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Chinese Medical Journal ; (24): 1207-1215, 2023.
Article in English | WPRIM | ID: wpr-980845


BACKGROUND@#LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.@*METHODS@#We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.@*RESULTS@#On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).@*CONCLUSION@#LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.@*TRIAL, NCT04563936.

Humans , Male , Antineoplastic Agents, Hormonal/therapeutic use , East Asian People , Gonadotropin-Releasing Hormone/agonists , Goserelin/therapeutic use , Prostate-Specific Antigen , Prostatic Neoplasms/drug therapy , Testosterone
Asian Journal of Andrology ; (6): 179-183, 2023.
Article in English | WPRIM | ID: wpr-971024


Management and treatment of terminal metastatic castration-resistant prostate cancer (mCRPC) remains heavily debated. We sought to investigate the efficacy of programmed cell death 1 (PD-1) inhibitor plus anlotinib as a potential solution for terminal mCRPC and further evaluate the association of genomic characteristics with efficacy outcomes. We conducted a retrospective real-world study of 25 mCRPC patients who received PD-1 inhibitor plus anlotinib after the progression to standard treatments. The clinical information was extracted from the electronic medical records and 22 patients had targeted circulating tumor DNA (ctDNA) next-generation sequencing. Statistical analysis showed that 6 (24.0%) patients experienced prostate-specific antigen (PSA) response and 11 (44.0%) patients experienced PSA reduction. The relationship between ctDNA findings and outcomes was also analyzed. DNA-damage repair (DDR) pathways and homologous recombination repair (HRR) pathway defects indicated a comparatively longer PSA-progression-free survival (PSA-PFS; 2.5 months vs 1.2 months, P = 0.027; 3.3 months vs 1.2 months, P = 0.017; respectively). This study introduces the PD-1 inhibitor plus anlotinib as a late-line therapeutic strategy for terminal mCRPC. PD-1 inhibitor plus anlotinib may be a new treatment choice for terminal mCRPC patients with DDR or HRR pathway defects and requires further investigation.

Male , Humans , Prostate-Specific Antigen , Treatment Outcome , Prostatic Neoplasms, Castration-Resistant/drug therapy , Immune Checkpoint Inhibitors/therapeutic use , Retrospective Studies
Asian Journal of Andrology ; (6): 82-85, 2023.
Article in English | WPRIM | ID: wpr-970999


This study investigated whether free prostate-specific antigen (fPSA) performs better than total PSA (tPSA) in predicting prostate volume (PV) in Chinese men with different PSA levels. A total of 5463 men with PSA levels of <10 ng ml-1 and without prostate cancer diagnosis were included in this study. Patients were classified into four groups: PSA <2.5 ng ml-1, 2.5-3.9 ng ml-1, 4.0-9.9 ng ml-1, and 2.5-9.9 ng ml-1. Pearson/Spearman's correlation coefficient (r) and receiver operating characteristic (ROC) curves were used to evaluate the ability of tPSA and fPSA to predict PV. The correlation coefficient between tPSA and PV in the PSA <2.5 ng ml-1 cohort (r = 0.422; P < 0.001) was markedly higher than those of the cohorts with PSA levels of 2.5-3.9 ng ml-1, 4.0-9.9 ng ml-1, and 2.5-9.9 ng ml-1 (r = 0.114, 0.167, and 0.264, respectively; all P ≤ 0.001), while fPSA levels did not differ significantly among different PSA groups. Area under ROC curve (AUC) analyses revealed that the performance of fPSA in predicting PV ≥40 ml (AUC: 0.694, 0.714, and 0.727) was better than that of tPSA (AUC = 0.545, 0.561, and 0.611) in men with PSA levels of 2.5-3.9 ng ml-1, 4.0-9.9 ng ml-1, and 2.5-9.9 ng ml-1, respectively, but not at PSA levels of <2.5 ng ml-1 (AUC: 0.713 vs 0.720). These findings suggest that the relationship between tPSA and PV may vary with PSA level and that fPSA is more powerful at predicting PV only in the ''gray zone'' (PSA levels of 2.5-9.9 ng ml-1), but its performance was similar to that of tPSA at PSA levels of <2.5 ng ml-1.

Male , Humans , Prostate-Specific Antigen , Prostate , East Asian People , Prostatic Neoplasms/diagnosis , ROC Curve
Asian Journal of Andrology ; (6): 132-136, 2023.
Article in English | WPRIM | ID: wpr-970993


A cross-sectional study was conducted to estimate the age-stratified normal levels and age-related changes in the risk predictors of benign prostatic hyperplasia (BPH) progression. A total of 4706 male participants aged 40 years or older in Zhengzhou (China) were enrolled. The values of the International Prostate Symptom Score (IPSS), prostate-specific antigen (PSA), prostate volume (PV), and postvoid residual urine volume (PVR) significantly increased with age. Nonlinear relationships between age and IPSS scores ≥8 (P for nonlinearity = 0.046), PSA level ≥1.6 ng ml-1, PV ≥31 ml, or PVR ≥39 ml (all P for nonlinearity <0.001) were observed. After the age of 61 years, the risk indicators related to BPH progression were positively correlated with age (odds ratio [OR] >1), regardless of the predictors of the IPSS score, PSA level, PV, or PVR; and the OR values increased gradually. Therefore, after the age of 61 years, the risk predictors related to BPH progression were positively correlated with age.

Humans , Male , Prostatic Hyperplasia/diagnosis , Prostate-Specific Antigen , Cross-Sectional Studies , East Asian People , Risk Factors
Asian Journal of Andrology ; (6): 126-131, 2023.
Article in English | WPRIM | ID: wpr-970991


This study explored a new model of Prostate Imaging Reporting and Data System (PIRADS) and adjusted prostate-specific antigen density of peripheral zone (aPSADPZ) for predicting the occurrence of prostate cancer (PCa) and clinically significant prostate cancer (csPCa). The demographic and clinical characteristics of 853 patients were recorded. Prostate-specific antigen (PSA), PSA density (PSAD), PSAD of peripheral zone (PSADPZ), aPSADPZ, and peripheral zone volume ratio (PZ-ratio) were calculated and subjected to receiver operating characteristic (ROC) curve analysis. The calibration and discrimination abilities of new nomograms were verified with the calibration curve and area under the ROC curve (AUC). The clinical benefits of these models were evaluated by decision curve analysis and clinical impact curves. The AUCs of PSA, PSAD, PSADPZ, aPSADPZ, and PZ-ratio were 0.669, 0.762, 0.659, 0.812, and 0.748 for PCa diagnosis, while 0.713, 0.788, 0.694, 0.828, and 0.735 for csPCa diagnosis, respectively. All nomograms displayed higher net benefit and better overall calibration than the scenarios for predicting the occurrence of PCa or csPCa. The new model significantly improved the diagnostic accuracy of PCa (0.945 vs 0.830, P < 0.01) and csPCa (0.937 vs 0.845, P < 0.01) compared with the base model. In addition, the number of patients with PCa and csPCa predicted by the new model was in good agreement with the actual number of patients with PCa and csPCa in high-risk threshold. This study demonstrates that aPSADPZ has a higher predictive accuracy for PCa diagnosis than the conventional indicators. Combining aPSADPZ with PIRADS can improve PCa diagnosis and avoid unnecessary biopsies.

Male , Humans , Prostate/pathology , Prostate-Specific Antigen/analysis , Prostatic Neoplasms/diagnostic imaging , Biopsy , Nomograms , Retrospective Studies
Asian Journal of Andrology ; (6): 43-49, 2023.
Article in English | WPRIM | ID: wpr-970989


Magnetic resonance imaging (MRI)-targeted prostate biopsy is the recommended investigation in men with suspicious lesion(s) on MRI. The role of concurrent systematic in addition to targeted biopsies is currently unclear. Using our prospectively maintained database, we identified men with at least one Prostate Imaging-Reporting and Data System (PI-RADS) ≥3 lesion who underwent targeted and/or systematic biopsies from May 2016 to May 2020. Clinically significant prostate cancer (csPCa) was defined as any Gleason grade group ≥2 cancer. Of 545 patients who underwent MRI fusion-targeted biopsy, 222 (40.7%) were biopsy naïve, 247 (45.3%) had previous prostate biopsy(s), and 76 (13.9%) had known prostate cancer undergoing active surveillance. Prostate cancer was more commonly found in biopsy-naïve men (63.5%) and those on active surveillance (68.4%) compared to those who had previous biopsies (35.2%; both P < 0.001). Systematic biopsies provided an incremental 10.4% detection of csPCa among biopsy-naïve patients, versus an incremental 2.4% among those who had prior negative biopsies. Multivariable regression found age (odds ratio [OR] = 1.03, P = 0.03), prostate-specific antigen (PSA) density ≥0.15 ng ml-2 (OR = 3.24, P < 0.001), prostate health index (PHI) ≥35 (OR = 2.43, P = 0.006), higher PI-RADS score (vs PI-RADS 3; OR = 4.59 for PI-RADS 4, and OR = 9.91 for PI-RADS 5; both P < 0.001) and target lesion volume-to-prostate volume ratio ≥0.10 (OR = 5.26, P = 0.013) were significantly associated with csPCa detection on targeted biopsy. In conclusion, for men undergoing MRI fusion-targeted prostate biopsies, systematic biopsies should not be omitted given its incremental value to targeted biopsies alone. The factors such as PSA density ≥0.15 ng ml-2, PHI ≥35, higher PI-RADS score, and target lesion volume-to-prostate volume ratio ≥0.10 can help identify men at higher risk of csPCa.

Male , Humans , Prostate/pathology , Prostatic Neoplasms/pathology , Prostate-Specific Antigen , Magnetic Resonance Imaging/methods , Image-Guided Biopsy/methods , Retrospective Studies
Frontiers of Medicine ; (4): 231-239, 2023.
Article in English | WPRIM | ID: wpr-982562


To evaluate the safety and efficacy of neoadjuvant radiohormonal therapy for oligometastatic prostate cancer (OMPC), we conducted a 3 + 3 dose escalation, prospective, phase I/II, single-arm clinical trial (CHiCTR1900025743), in which long-term neoadjuvant androgen deprivation was adopted 1 month before radiotherapy, comprising intensity modulated radiotherapy to the pelvis, and stereotactic body radiation therapy to all extra-pelvic bone metastases for 4-7 weeks, at 39.6, 45, 50.4, and 54 Gy. Robotic-assisted radical prostatectomy was performed after 5-14 weeks. The primary outcome was treatment-related toxicities and adverse events; secondary outcomes were radiological treatment response, positive surgical margin (pSM), postoperative prostate-specific antigen (PSA), pathological down-grading and tumor regression grade, and survival parameters. Twelve patients were recruited from March 2019 to February 2020, aging 66.2 years in average (range, 52-80). Median baseline PSA was 62.0 ng/mL. All underwent RARP successfully without open conversions. Ten patients recorded pathological tumor down-staging (83.3%), and 5 (41.7%) with cN1 recorded negative regional lymph nodes on final pathology. 66.7% (8/12) recorded tumor regression grading (TRG) -I and 25% (3/12) recorded TRG-II. Median follow-up was 16.5 months. Mean radiological progression-free survival (RPFS) was 21.3 months, with 2-year RPFS of 83.3%. In all, neoadjuvant radiohormonal therapy is well tolerated for oligometastatic prostate cancer.

Male , Humans , Prostatic Neoplasms/radiotherapy , Prostate-Specific Antigen/therapeutic use , Neoadjuvant Therapy , Androgen Antagonists/therapeutic use , Prospective Studies
Article in English | WPRIM | ID: wpr-982027


OBJECTIVES@#To investigate the prevalence of pathogenic germline mutations of mismatch repair (MMR) genes in prostate cancer patients and its relationship with clinicopathological characteristics.@*METHODS@#Germline sequencing data of 855 prostate cancer patients admitted in Fudan University Shanghai Cancer Center from 2018 to 2022 were retrospectively analyzed. The pathogenicity of mutations was assessed according to the American College of Medical Genetics and Genomics (ACMG) standard guideline, Clinvar and Intervar databases. The clinicopathological characteristics and responses to castration treatment were compared among patients with MMR gene mutation (MMR+ group), patients with DNA damage repair (DDR) gene germline pathogenic mutation without MMR gene (DDR+MMR- group) and patients without DDR gene germline pathogenic mutation (DDR- group).@*RESULTS@#Thirteen (1.52%) MMR+ patients were identified in 855 prostate cancer patients, including 1 case with MLH1 gene mutation, 6 cases with MSH2 gene mutation, 4 cases with MSH6 gene mutation and 2 cases with PMS2 gene mutation. 105 (11.9%) patients were identified as DDR gene positive (except MMR gene), and 737 (86.2%) patients were DDR gene negative. Compared with DDR- group, MMR+ group had lower age of onset (P<0.05) and initial prostate-specific antigen (PSA) (P<0.01), while no significant differences were found between the two groups in Gleason score and TMN staging (both P>0.05). The median time to castration resistance was 8 months (95%CI: 6 months-not achieved), 16 months (95%CI: 12-32 months) and 24 months (95%CI: 21-27 months) for MMR+ group, DDR+MMR- group and DDR- group, respectively. The time to castration resistance in MMR+ group was significantly shorter than that in DDR+MMR- group and DDR- group (both P<0.01), while there was no significant difference between DDR+MMR- group and DDR- group (P>0.05).@*CONCLUSIONS@#MMR gene mutation testing is recommended for prostate cancer patients with early onset, low initial PSA, metastasis or early resistance to castration therapy.

Male , Humans , Prostate-Specific Antigen/genetics , Germ-Line Mutation , Retrospective Studies , DNA Mismatch Repair/genetics , DNA-Binding Proteins/metabolism , China , Prostatic Neoplasms/pathology
Oncología (Guayaquil) ; 32(3): 273-281, 2 de diciembre del 2022.
Article in Spanish | LILACS | ID: biblio-1411144


Introducción: El cáncer de próstata (CP) el segundo cáncer diagnosticado en hombres, con mayor incidencia a los 66 años. La obesidad, el tabaquismo, alcoholismo y antecedentes familiares de CP se han encontrado asociados al riesgo de metástasis. El objetivo del presente estudio fue medir la aso-ciación entre factores y el estado metastásico en pacientes con CP en un centro único de referencia en Ecuador. Metodología: El presente estudio analítico, se realizó en el Hospital "Teodoro Maldonado Carbo", en Guayaquil-Ecuador, en el período enero-diciembre del 2019. El cálculo muestral fue no probabilístico, tipo censo. Se incluyeron casos con CP. Las variables fueron: edad, PSA, escala de Gleason, presencia de metástasis, sintomatología, tabaquismo, obesidad y antecedentes. Se presenta Odds Ratio como medida de asociación con intervalo de confianza del 95% y valor P. Resultados: El estudio incluyó 363 pacientes, con edad promedio de 75.2 ± 9.6 años. El grupo con metástasis fue de 202 casos (55.65%). Metástasis ósea 32.5%, pulmonar 9.6%, ganglionar 8.8% y hepático 4.75%. En la sintomatología la más frecuente fue, disuria (44.4%); el 33.6% con polaquiuria, un 13.2% hematuria y 8.8% tenesmo. El estadio Gleason-9 OR=24.85 (IC 95% 1.47-419.8) P=0.0259. El nivel de PSA >19 ng/ml OR= 6.996 (IC 95% 2.68-18.29) P=0.0001. El tabaquismo OR=2.34 (IC 95% 1.52-3.60) P=0.0001. Fueron factores protectores el valor de PSA <19 ng/ml OR=0.082 (IC 95% 0.043-0.157) P<0.0001, acudir a consulta de Hipertensión arterial OR=0.33 (IC 95% 0.161-0.691) P=0.0032 y el estadío Gleason-6 OR=0.108 (IC 95% 0.0665-9.1736) P<0.0001. Conclusión: Los niveles de PSA >19 ng/ml y el estadio Gleason >9 se asocian a la presencia de metástasis en pacientes con CP.

Introduction: Prostate cancer (PC) is the second most common cancer diagnosed in men, with the highest incidence at 66 years of age. Obesity, smoking, alcoholism, and a family history of PC are associated with the risk of metastasis. This study aimed to measure the association between factors and the metastatic state in patients with PC in a single reference center in Ecuador. Methodology: This analytical study was conducted at the "Teodoro Maldonado Carbo" Hospital in Guayaquil-Ecuador, January-December 2019. The sample calculation was nonprobabilistic, census type, and cases with PC were included. The variables were age, PSA, Gleason score, presence of me-tastases, symptoms, smoking, obesity, and history. The odds ratio was used to measure the associa-tion with a 95% confidence interval and P value. Results: The study included 363 patients, with a mean age of 75.2 ± 9.6 years. The group with me-tastasis included 202 patients (55.65%). Bone metastasis 32.5%, lung 9.6%, lymph nodes 8.8%, and liver 4.75%. In the symptomatology, the most frequent were dysuria (44.4%), 33.6% with pollakiuria, 13.2% hematuria, and 8.8% tenesmus. Gleason stage-9 OR=24.85 (95% CI 1.47-419.8) P=0.0259. PSA level >19 ng/ml OR= 6.996 (95% CI 2.68-18.29) P =0.0001. Smoking OR=2.34 (95% CI 1.52-3.60) P=0.0001. Protective factors were PSA value <19 ng/ml OR=0.082 (95% CI 0.043-0.157) P<0.0001, arterial hypertension consultation OR=0.33 (95% CI 0.161-0.691) P=0.0032 and stage Gleason-6 OR=0.108 (95% CI 0.0665-9.1736) P<0.0001. Conclusión: PSA levels >19 ng/ml and Gleason stage > nine are associated with metastases in patients with PC.

Humans , Prostatic Neoplasms , Prostate-Specific Antigen , Odds Ratio , Risk Factors , Neoplasm Metastasis
Rev. cuba. med ; 61(3)sept. 2022.
Article in Spanish | LILACS, CUMED | ID: biblio-1441678


Introducción: El desarrollo de la tecnología con el ultrasonido transrectal ha permitido obtener imágenes diagnósticas de la glándula prostática; su interés deriva de la inmensa frecuencia de problemas clínicos, tanto benignos como malignos. El medio diagnóstico del cáncer de próstata se basa en una biopsia dirigida por ultrasonido transrectal en la mayoría de los casos. Objetivo: Determinar los hallazgos ultrasonográficos y su relación con estudios histopatológico en el diagnóstico de la neoplasia prostática, de los pacientes con sospecha, atendidos en la consulta de urooncología. Métodos: Se realizó un estudio descriptivo transversal en pacientes con sospecha clínica de cáncer prostático, procedentes del servicio de urología en el Hospital Celia Sánchez Manduley en el período comprendido entre julio de 2019 a julio de 2021; que acudieron a consulta con indicación de ultrasonido transrectal. El universo estuvo constituido por 105 pacientes. Se utilizaron criterios de inclusión y exclusión para la selección del universo, previo consentimiento informado de los pacientes. Las variables estudiadas fueron: edad, color de la piel, síntomas clínicos, hallazgos del ultrasonido transrectal, relación ecosonográfica- anatomopatológico. Resultados: Predominó el grupo de edad de 60 a 79 años, de la raza negra, con síntomas urinarios obstructivos bajos, con presencia del nódulo hipoecoico. Predominó la localización ultrasonográfica periférica, así como el adenocarcinoma prostático como hallazgos anatomopatológico encontrado a través de la biopsia. Conclusiones: Se demostró correlación ecográfica-histológica y anatomopatológica(AU)

Introduction: The development of transrectal ultrasound technology has made it possible to obtain diagnostic images of the prostate gland; its interest derives from the massive frequency of clinical problems, both benign and malignant. The diagnosis of prostate cancer is based on a transrectal ultrasound-guided biopsy in most cases. Objective: To determine the ultrasonographic findings and the how they relate with histopathological studies in the diagnosis of prostatic neoplasia in suspected patients treated in the uro-oncology clinic. Methods: A cross-sectional descriptive study was carried out in patients with clinical suspicion of prostate cancer, in the urology service at Celia Sánchez Manduley Hospital from July 2019 to July 2021; they attended the consultation with an indication for transrectal ultrasound. The universe consisted of 105 patients. Inclusion and exclusion criteria were used for the selection of the universe, with the prior informed consent of the patients. The variables studied were age, skin color, clinical symptoms, transrectal ultrasound findings, echosonographic-pathological relationship. Results: Predominance was observed of subjects from the age group of 60 to 79 years, black race, with lower obstructive urinary symptoms, and presence of hypoechoic nodule. Peripheral ultrasonographic location prevailed, as well as prostatic adenocarcinoma as pathological findings found through biopsy. Conclusions: Ultrasound-histological and pathological correlation was demonstrated(AU)

Humans , Male , Female , Prostate-Specific Antigen , Prostatic Intraepithelial Neoplasia/epidemiology , Ultrasound, High-Intensity Focused, Transrectal/methods , Digital Rectal Examination/methods , Epidemiology, Descriptive , Cross-Sectional Studies
Rev. cuba. med ; 61(2): e2583, abr.-jun. 2022. tab, graf
Article in Spanish | LILACS, CUMED | ID: biblio-1408990


Introducción: Al día de hoy no se ha alcanzado un consenso sobre el mejor enfoque para realizar el tamizaje y la detección precoz del Cáncer de Próstata (CaP), en la población. No obstante, hay programas que recomiendan la utilización de la prueba de antígeno prostático específico rápida para la detección de CaP sin un análisis de correlación frente a la prueba sérica. Objetivo: Identificar la correlación entre las pruebas de antígeno prostático específico rápida y sérica, en la población mexicana. Métodos: Se realizó un estudio descriptivo, transversal y retrospectivo, bajo un muestreo no probabilístico por conveniencia. En el período comprendido entre el 25 de mayo al 13 de julio de 2017. Se calcularon los coeficientes de correlación punto biserial (r pb ) y phi (r phi ). Resultados: Se incluyeron 1 635 registros, principalmente de la Ciudad de México y del Estado de México (n= 1 398; 85,5 por ciento, IC95 por ciento 81-89,9). La edad promedio fue de 51 años (DE= 7,68). El valor promedio de antígeno prostático sérico fue de 1,49 ng/mL (DE= 1,91). La proporción de hombres con una prueba rápida positiva (n=60; 3,7 por ciento; IC95 por ciento 2,9-4,6) fue menor (p= 0,0415) en comparación con la proporción de pacientes con una prueba sérica ≥ 4 ng/mL (n=85; 5,2 por ciento; IC95 por ciento 4,1-6,3). El número de casos dobles negativos fue de 1 530 (93,6 por ciento; IC95 por ciento 92,3-94,6) y de dobles positivos fue de 40 (2,4 por ciento; IC95 por ciento1,7-3,2). Los coeficientes de correlación punto biserial y phi mostraron una correlación baja entre la prueba rápida y la prueba sérica de antígeno prostático (rpb= 0,469; p < 0,001; r2= 0,2199 y r ph i= 0,540; p < 0,001; r2= 0,2916). Conclusiones: La prueba de antígeno prostático específico rápida es una herramienta conveniente para los programas de detección de alteración prostática en unidades médicas del primer nivel de atención, donde la prueba sérica no se puede realizar, al ser una prueba con una baja sensibilidad y con un bajo coeficiente de correlación respecto de la prueba de antígeno prostático específico sérica, esto es un punto importante que debe considerarse al diseñar programas de detección oportuna de cáncer de próstata(AU)

Introduction: To date, no consensus has been reached on the best approach for screening and early detection of Prostate Cancer (PCa) in the population. However, there are programs recommending the use of the rapid prostate-specific antigen test for the detection of PCa without a correlation analysis versus the serum test. Objective: To identify the correlation between rapid and serum prostate specific antigen tests in the Mexican population. Methods: A descriptive, cross-sectional and retrospective study was carried out, under a non-probabilistic convenience sampling from May 25 to July 13, 2017. The correlation coefficients of point biserial (rpb) and phi (rphi) were calculated. Results: One thousand six hundred thirty five (1,635) records were included, mainly from Mexico City and the State of Mexico (n= 1,398; 85.5 percent, 95 percent CI 81-89.9). The average age was 51 years (SD= 7.68). The mean value of serum prostate antigen was 1.49 ng/ml (SD= 1.91). The proportion of men with positive rapid test (n=60; 3.7 percent; 95 percent CI 2.9-4.6) was lower (p= 0.0415) compared to the proportion of patients with a serum test ≥ 4 ng/ml (n= 85; 5.2 percent; 95 percent CI 4.1-6.3). The number of double negative cases was 1,530 (93.6 percent; CI95 percent 92.3-94.6) and of double positives was 40 (2.4 percent; CI95 percent 1.7-3.2). The point biserial and phi correlation coefficients showed low correlation between the rapid test and the serum prostate antigen test (rpb= 0.469; p < 0.001; r2= 0.2199 and rphi= 0.540; p < 0.001; r2= 0. 2916). Conclusions: The rapid prostate-specific antigen test is a convenient tool for prostatic alteration detection programs in primary care medical units, where the serum test cannot be performed, however, as it is a test with low sensitivity and with low correlation coefficient with respect to serum prostate-specific antigen testing, this is an important point to consider when designing prostate cancer early detection programs(AU)

Humans , Male , Prostatic Neoplasms/diagnosis , Mass Screening , Prostate-Specific Antigen , Epidemiology, Descriptive , Cross-Sectional Studies , Retrospective Studies , Mexico
Acta bioquím. clín. latinoam ; 56(1): 11-15, ene. 2022. graf
Article in Spanish | LILACS, BINACIS | ID: biblio-1402942


Resumen El antígeno prostático específico (PSA) en circulación se encuentra ligado a la alfa-1-quimiotripsina y una pequeña fracción circula de manera libre (PSAl). Se valoró la utilidad clínica del PSA total (PSAt) y el índice de PSA libre para la detección de cáncer prostático en pacientes asintomáticos. Se cuantificó el PSAt, el PSAl y el índice de PSAl en 364 pacientes estratificados por grupo de edad. La frecuencia de valores anormales de PSAt fue del 8,79% (32/364). El grupo de 50-59 años presentó la mayor incidencia de resultados anormales (19/32). No hubo diferencia estadísticamente significativa entre PSAt y el índice de PSAl (p<0,05). El índice PSAl puede potencializar el valor del PSAt para determinar la presencia o ausencia de cáncer prostático. Un índice superior a 0,24 ng/mL puede ayudar a evitar o posponer la indicación de biopsia, principalmente cuando los valores de PSAt están entre 4 y 10 ng/mL.

Abstract Circulating prostate-specific antigen (PSA) is bound to alpha-1-chymotrypsin and a small fraction is free (PSAl). The clinical utility of the total PSA (PSAt) and the PSAl index for prostate cancer screening in asymptomatic patients was assessed. PSAt, PSAl and the PSAl index were quantified in 364 patients stratified by age group. The frequency of abnormal PSAt values was 8.79% (32/364). The 50-59 year-old group presented the highest incidence of abnormal results (19/32). There was no statistically significant difference between PSAt and the PSAl index (p<0.05). The PSAl index can potentiate the PSAt value to determine the presence or absence of prostate cancer. An index greater than 0.24 ng/mL can help to avoid or postpone the indication for a biopsy, especially when the PSAt values are between 4 and 10 ng/mL.

Resumo O antígeno prostático específico (PSA) em circulação é ligado à alfa-1-quimotripsina e a uma pequena fração circula livremente (PSAl). A utilidade clínica do PSA total (PSAt) e do índice de PSAl livre para o rastreamento do câncer de próstata em pacientes assintomáticos foi avaliada. PSAt, PSAl e o índice de PSAl foram quantificados em 364 pacientes estratificados por faixa etária. A frequência de valores anormais de PSAt foi de 8,79% (32/364). O grupo de 50-59 anos apresentou a maior incidência de resultados anormais (19/32). Não houve diferença estatisticamente significativa entre o PSAt e o índice PSAl (p<0,05). O índice PSAl pode potencializar o valor do PSAt para determinar a presença ou ausência de câncer de próstata. Um índice superior a 0,24 ng/mL pode ajudar a evitar ou adiar a indicação de biópsia, principalmente quando os valores de PSAt estão entre 4 e 10 ng/mL.

Male , Adult , Middle Aged , Aged , Prostatic Hyperplasia , Prostatic Neoplasms , Prostate-Specific Antigen , Serine Peptidase Inhibitor Kazal-Type 5 , Patients , Biopsy , Chymotrypsin , Mass Screening , Incidence , Morbidity , Diagnosis , Absenteeism , AlkB Homolog 3, Alpha-Ketoglutarate-Dependent Dioxygenase , Age Groups
Article in Portuguese | LILACS, CONASS, ColecionaSUS, SES-GO | ID: biblio-1370822


O antígeno prostático específico (PSA) é o marcador mais importante para a detecção e monitoramento do câncer de próstata. Objetivo: O estudo objetivou analisar os dados laboratoriais e epidemiológicos do antígeno prostático específico de pacientes atendidos no Laboratório Clínico do Hospital do Policial Militar de Goiânia-GO (LC/HPM), considerando as medidas preventivas em relação ao câncer de próstata. Trata-se de um estudo retrospectivo baseado na análise de 1.249 prontuários de usuários do LC/HPM. O levantamento de dados laboratoriais e epidemiológicos, como idade, resultados do PSA total e PSA livre foi realizado por meio de um formulário padronizado pelos pesquisadores. Foram analisados 1.249 exames de PSA L/T, dos quais 58 (4,6%) apresentaram PSA total com resultados entre 4,0 e 10,0 ng/mL e 16 (1,3%) apresentaram concomitantemente valores de PSA total entre 4,0 e 10,0 ng/mL e relação PSA L/T < 25%. Os pacientes apresentaram faixa etária entre 34 e 93 anos, sendo a média 60 anos. Tornou-se evidente que tanto no ano de 2018 quanto em 2019, realizou-se um número maior de exames de PSA L/T, em comparação ao ano de 2020. O estudo revelou que 16 (1,3%) pacientes apresentaram risco aumentado para o desenvolvimento de neoplasia prostática, sendo observada uma diminuição do número de indivíduos que procuraram o LC/HPM para realização de exames de PSA livre e total no ano de 2020, quando comparado aos anos de 2019 e 2018, possivelmente em razão da pandemia de Covid-19, uma tendência global

Prostate-specific antigen (PSA) is the most important marker for the detection and monitoring of prostate cancer. This study aimed to analyse the epidemiological and laboratory data of prostate-specific antigen of patients treated at the Clinical Laboratory of the Military Police Hospital at Goiânia-GO (CL/MPH), considering preventive measures in relation to prostate cancer. Methods: This is a retrospective study with analysis of 1,249 medical records of CL/MPH users. The collection of epidemiological and laboratory data, such as age, total PSA and free PSA results, was performed using a form standardized by the researchers. We analyzed 1,249 PSA T/F tests, and of these, of which 58 (4.6%) total PSA sink with results between 4.0 and 10.0 ng/mL and 16 (1.3%) were concomitantly presenting total PSA values between 4.0 and 10.0 ng/mL and PSA T/F < 25%. The patients were aged between 34 and 93 years, with a mean age of 59 years. It became evident that both in 2018 and in 2019, there were a greater number of PSA T/F exams, compared to 2020. This study revealed that 16 (1.3%) patients were at increased risk for the development of prostate cancer, with a decrease in the number of individuals who sought the CL/MPH for free and total PSA tests in 2020, compared to 2019 and 2018, possibly due to Covid-19 pandemic, a global trend

Humans , Male , Adult , Middle Aged , Aged , Aged, 80 and over , Prostatic Neoplasms/prevention & control , Prostate-Specific Antigen/blood , Prostatic Neoplasms/diagnosis , Medical Records/statistics & numerical data , Retrospective Studies , Hospitals, Military
Med. lab ; 26(1): 91-98, 2022. ilus, Grafs, Tabs
Article in Spanish | LILACS | ID: biblio-1370967


El antígeno específico de próstata (PSA, del inglés, Prostate Specific Antigen) es una glicoproteína producida por la próstata, y es el marcador tumoral de mayor uso. Sin embargo, su baja especificidad para diferenciar entre cáncer de próstata y otras alteraciones no malignas, como la hipertrofia benigna de la próstata (HBP) y la prostatitis aguda, limitan su utilidad diagnóstica

Prostate Specific Antigen (PSA) is a glycoprotein produced by the prostate and is the most widely used tumor marker. However, its low specificity to differentiate between prostate cancer and other non-malignant conditions, such as benign prostate hypertrophy (BPH) and acute prostatitis, limits its diagnostic utility

Prostate-Specific Antigen , Prostatic Hyperplasia , Prostatitis , Platelet Membrane Glycoproteins , Biomarkers, Tumor
urol. colomb. (Bogotá. En línea) ; 31(2): 73-81, 2022. ilus
Article in English | LILACS, COLNAL | ID: biblio-1411986


Purpose To identify metabolites in humans that can be associated with the presence of malignant disturbances of the prostate. Methods In the present study, we selected male patients aged between 46 and 82 years who were considered at risk of prostate cancer due to elevated levels of prostate-specific antigen (PSA) or abnormal results on the digital rectal examination. All selected patients came from two university hospitals (Hospital Universitario del Valle and Clínica Rafael Uribe Uribe) and were divided into 2 groups: cancer (12 patients) and non-cancer (20 patients). Cancer was confirmed by histology, and none of the patients underwent any previous treatment. Standard protocols were applied to all the collected blood samples. The resulting plasma samples were kept at -80°C, and a profile of each one was acquired by nuclear magnetic resonance (NMR) using established experiments. Multivariate analyses were applied to this dataset, first to establish the quality of the data and identify outliers, and then, to model the data. Results We included 12 patients with cancer and 20 without it. Two patients were excluded due to contamination with ethanol. The remaining ones were used to build an Orthogonal Projections to Latent Structures Discriminant Analysis (OPLS-DA) model (including 15 non-cancer and 10 cancer patients), with acceptable discrimination (Q2 = 0.33). This model highlighted the role of lactate and lipids, with a positive association of these two metabolites and prostate cancer. Conclusions The primary discriminative metabolites between patients with and without prostate cancer were lactate and lipids. These might be the most reliable biomarkers to trace the development of cancer in the prostate.

Objetivo Identificar metabolitos en humanos que pueden estar asociados con la presencia de alteraciones malignas de la próstata. Métodos Se incluyeron muestras de pacientes masculinos entre 46 y 82 años y que se consideraron en riesgo de cáncer de próstata debido a la elevación del antígeno prostático específico (PSA) o el examen rectal anormal. Todos los pacientes seleccionados procedían de dos hospitales universitarios (Hospital Universitario del Valle y Clínica Rafael Uribe Uribe) y se dividieron en dos grupos: Oncológicos (12) vs no oncológicos (20). El cáncer fue confirmado por histología, y ninguno de ellos recibió tratamiento previo. Se aplicaron protocolos estándar a todas las muestras de sangre recolectadas. Las muestras de plasma resultantes se mantuvieron a −80°C y se adquirió un perfil de cada muestra mediante RMN. Se aplicaron análisis multivariantes a este conjunto de datos, primero para establecer la calidad de los datos e identificar valores atípicos, y para modelar los datos. Resultados Se incluyeron 12 pacientes con cáncer y 20 pacientes sin cáncer. Dos pacientes fueron excluidos por contaminación con etanol. Los restantes se utilizaron para construir un modelo OPLS-DA (15 pacientes no oncológicos y diez oncológicos), con una discriminación aceptable (Q2 = 0,33). Este modelo destacó el papel del lactato y los lípidos, encontrando una asociación positiva entre estos dos metabolitos y el cáncer de próstata. Conclusiones Los principales metabolitos discriminativos entre pacientes con cáncer de próstata versus no cáncer fueron el lactato y los lípidos. Estos podrían ser los biomarcadores más confiables para rastrear el desarrollo del cáncer en la próstata.

Humans , Male , Prostate , Prostatic Neoplasms , Metabolomics , Magnetic Resonance Spectroscopy , Discriminant Analysis , Multivariate Analysis , Prostate-Specific Antigen , Lactic Acid , Digital Rectal Examination , Social Discrimination
urol. colomb. (Bogotá. En línea) ; 31(3): 116-120, 2022. ilus
Article in English | LILACS, COLNAL | ID: biblio-1412081


Introduction For low-risk prostate cancer (PCa), curative treatment with radical prostatectomy (RP) can be performed, reporting a biochemical relapse-free survival rate (bRFS) at 5 and 7 years of 90.1% and 88.3%, respectively. Prostatic specific antigen (PSA), pathological stage (pT), and positive margins (R1) are significant predictors of biochemical relapse (BR). Even though pelvic lymphadenectomy is not recommended during RP, in the literature, it is performed in 34% of these patients, finding 0.37% of positive lymph nodes (N1). In this study, we aim to evaluate the 10-year bRFS in patients with low-risk PCa who underwent RP and extended pelvic lymph node dissection (ePLND). Methodology All low-risk patients who underwent RP plus bilateral ePLND at the National Cancer Institute of Colombia between 2006 and 2019 were reviewed. Biochemical relapse was defined as 2 consecutive increasing levels of PSA > 0.2 ng/mL. A descriptive analysis was performed using the STATA 15 software (Stata Corp., College Station, TX, USA), and the Kaplan-Meier curves and uni and multivariate Cox proportional hazard models were used for the survival outcome analysis. The related regression coefficients were used for the hazard ratio (HR), and, for all comparisons, a two-sided p-value ˂ 0.05 was used to define statistical significance. Results Two hundred and two patients met the study criteria. The 10-year bRFS for the general population was 82.5%, statistically related to stage pT3 (p = 0.047), higher Gleason grade group (GG) (p ≤ 0.001), and R1 (p ≤ 0.001), but not with N1. A total of 3.9% of the patients had N1; of these, 75% had R1, 25% GG2, and 37% GG3. Among the N0 (non-lymph node metástasis in prostate cáncer) patients, 31% of the patients had R1, 41% GG2, and 13% GG3. Conclusions Our bRFS was 82.5% in low-risk patients who underwent RP and ePLND. With higher pT, GG, and presence of R1, the probability of BR increased. Those with pN1 (pathologicaly confirmed positive lymph nodes) were not associated with bRFS, with a pN1 detection rate of 3.9%. Details: In low-risk PCa, curative treatment with RP can be performed, reporting a bRFS rate at 5 and 7 years of 90.1% and 88.3%, respectively. Despite the fact that pelvic lymphadenectomy is not recommended during RP in clinical guidelines, in the literature, it is performed in 34% of these patients, finding 0.37% of N1. In this study, we report the 10-year bRFS in patients with low-risk PCa who underwent surgery.

Introducción En el cáncer de próstata (CaP) de bajo riesgo se puede realizar un tratamiento curativo mediante prostatectomía radical (PR), con una tasa de supervivencia libre de recaída bioquímica (SLRb) a 5 y 7 años del 90,1% y el 88,3%, respectivamente. El antígeno prostático específico (PSA), el estadio patológico (pT) y los márgenes positivos (R1) son predictores significativos de recaída bioquímica (BR). Aunque la linfadenectomía pélvica no está recomendada durante la PR, en la literatura se realiza en el 34% de estos pacientes, encontrándose un 0,37% de ganglios linfáticos positivos (N1). En este estudio, nuestro objetivo es evaluar la SLB a 10 años en pacientes con CaP de bajo riesgo sometidos a PR y disección ganglionar pélvica extendida (DGLPe). Metodología Se revisaron todos los pacientes de bajo riesgo sometidos a PR más ePLND bilateral en el Instituto Nacional de Cancerología de Colombia entre 2006 y 2019. La recaída bioquímica se definió como 2 niveles crecientes consecutivos de PSA > 0,2 ng/mL. Se realizó un análisis descriptivo utilizando el software STATA 15 (Stata Corp., College Station, TX, USA), y se utilizaron las curvas de Kaplan-Meier y los modelos uni y multivariados de riesgos proporcionales de Cox para el análisis de resultados de supervivencia. Los coeficientes de regresión relacionados se utilizaron para la hazard ratio (HR), y, para todas las comparaciones, se utilizó un valor p de dos caras ˂ 0,05 para definir la significación estadística. Resultados Doscientos dos pacientes cumplieron los criterios del estudio. La bRFS a 10 años para la población general fue del 82,5%, estadísticamente relacionada con el estadio pT3 (p = 0,047), mayor grupo de grado Gleason (GG) (p ≤ 0,001), y R1 (p ≤ 0,001), pero no con N1. Un total del 3,9% de los pacientes tenían N1; de ellos, el 75% tenían R1, el 25% GG2, y el 37% GG3. Entre los pacientes N0 (metástasis no ganglionar en el cáncer de próstata), el 31% de los pacientes tenían R1, el 41% GG2 y el 13% GG3. Conclusiones Nuestra SSEb fue del 82,5% en los pacientes de bajo riesgo que se sometieron a RP y ePLND. A mayor pT, GG y presencia de R1, mayor probabilidad de RB. Aquellos con pN1 (ganglios linfáticos patológicamente confirmados como positivos) no se asociaron con la SSEb, con una tasa de detección de pN1 del 3,9%. Detalles: En el CaP de bajo riesgo se puede realizar tratamiento curativo con PR, reportando una tasa de SSEb a 5 y 7 años de 90,1% y 88,3%, respectivamente. A pesar de que la linfadenectomía pélvica no está recomendada durante la PR en las guías clínicas, en la literatura se realiza en el 34% de estos pacientes, encontrando un 0,37% de N1. En este estudio, reportamos la SLB a 10 años en pacientes con CaP de bajo riesgo sometidos a cirugía.

Humans , Male , Prostatectomy , Biochemistry , Proportional Hazards Models , Medical Oncology , Neoplasm Metastasis , Prostatic Neoplasms , Therapeutics , Passive Cutaneous Anaphylaxis , Probability , Prostate-Specific Antigen , Hazards , Lymphatic Metastasis
Journal of Integrative Medicine ; (12): 244-251, 2022.
Article in English | WPRIM | ID: wpr-929229


OBJECTIVE@#Emerging evidence shows the effectiveness of speech and language therapy (SLT); however, precise therapeutic parameters remain unclear. Evidence for the use of adjunctive transcranial direct current stimulation (tDCS) to treat post-stroke aphasia (PSA) is promising; however, the utility of combining tDCS and electroacupuncture (EA) has not yet been analyzed. This study assessed the therapeutic consequences of EA and tDCS coupled with SLT in subacute PSA patients who were also undergoing hyperbaric oxygen therapy (HBOT).@*METHODS@#A retrospective analysis was conducted on subacute (< 6 months) PSA patients who were divided into three groups: patients who received EA plus tDCS (acupuncture group), patients who underwent tDCS (tDCS group), and patients who experienced conventional therapy (HBOT + SLT). All subjects underwent 21 days of treatment and also received conventional treatment. The aphasia battery of Chinese (ABC) was used to score pre- and post-intervention status.@*RESULTS@#The analysis comprised 238 patients. Cerebral infarction was the most frequent stroke type (137 [57.6%]), while motor (66 [27.7%]) and global aphasia (60 [25.2%]) were the most common types of aphasia. After 21 days of intervention, the ABC scores of all patients were improved. The acupuncture group had the highest ABC scores, but only repetition, naming, and spontaneous speech were statistically improved (P < 0.01). Post-hoc tests revealed significant improvement in word retrieval in the acupuncture and tDCS groups (P < 0.01, P = 0.037), while the acupuncture group had additional significant improvement in spontaneous conversation (P < 0.01).@*CONCLUSION@#Combining acupuncture and tDCS as an adjuvant therapy for subacute PSA led to significant spontaneous speech and word retrieval improvements. Future prospective, multi-ethnic, multi-center trials are warranted.

Humans , Male , Aphasia/therapy , Electroacupuncture , Prostate-Specific Antigen , Retrospective Studies , Transcranial Direct Current Stimulation
Asian Journal of Andrology ; (6): 195-200, 2022.
Article in English | WPRIM | ID: wpr-928548


The goal of this study was to investigate the clinical application of free/total prostate-specific antigen (F/T PSA) ratio, considering the new broad serum total PSA (T-PSA) "gray zone" of 2.0-25.0 ng ml-1 in differential diagnosis of prostate cancer (PCa) and benign prostate diseases (BPD) in men over 50 years in Western China. A total of 1655 patients were included, 528 with PCa and 1127 with BPD. Serum T-PSA, free PSA (F-PSA), and F/T PSA ratio were analyzed. Receiver operating characteristic curves were used to assess the efficiency of PSA and F/T PSA ratio. There were 47.4% of cancer patients with T-PSA of 2.0-25.0 ng ml-1. When T-PSA was 2.0-4.0 ng ml-1, 4.0-10.0 ng ml-1, and 10.0-25.0 ng ml-1, the area under the curve (AUC) of F/T PSA ratio was 0.749, 0.769, and 0.761, respectively. The best AUC of F/T PSA ratio was 0.811 when T-PSA was 2.0-25.0 ng ml-1, with a specificity of 0.732, a sensitivity of 0.788, and an optimal cutoff value of 15.5%. The AUC of F/T PSA ratio in different age groups (50-59 years, 60-69 years, 70-79 years, and ≥80 years) was 0.767, 0.806, 0.815, and 0.833, respectively, and the best sensitivity (0.857) and specificity (0.802) were observed in patients over 80 years. The T-PSA trend was in accordance with the Gleason score, tumor node metastasis (TNM) stage, and American Joint Committee on Cancer prognosis group. Therefore, the F/T PSA ratio can facilitate the differential diagnosis of PCa and BPD in the broad T-PSA "gray zone". Serum T-PSA can be a Gleason score and prognostic indicator.

Humans , Male , Middle Aged , Area Under Curve , Prostate-Specific Antigen , Prostatic Neoplasms/pathology , ROC Curve , Sensitivity and Specificity
Asian Journal of Andrology ; (6): 154-160, 2022.
Article in English | WPRIM | ID: wpr-928527


Corticosteroid switching can reverse abiraterone resistance in some patients with metastatic castration-resistant prostate cancer (mCRPC). Here, we investigated the potential biomarkers for predicting the efficacy of corticosteroid switching during treatment with abiraterone acetate (AA). We retrospectively analyzed 101 mCRPC patients receiving corticosteroid switching from West China Hospital and Sun Yat-Sen University Cancer Center between January 2016 and December 2018. All cases received AA plus prednisone as first-line therapy during mCRPC. Primary end points were biochemical progression-free survival (bPFS) and overall survival (OS). The risk groups were defined based on multivariate analysis. A total of 42 (41.6%) and 25 (24.8%) patients achieved 30% and 50% decline in prostate-specific antigen (PSA), respectively, after corticosteroid switching. The median bPFS and median OS on AA plus dexamethasone were 4.9 (95% confidence interval [CI]: 3.7-6.0) months and 18.8 (95% CI: 16.2-30.2) months, respectively. Aldo-keto reductase family 1 member C3 (AKR1C3) expression (hazard ratio [HR]: 2.15, 95% Cl: 1.22-3.80, P = 0.008) and baseline serum alkaline phosphatase (ALP; HR: 4.95, 95% Cl: 2.40-10.19, P < 0.001) were independent predictors of efficacy before corticosteroid switching in the multivariate analysis of bPFS. Only baseline serum ALP >160 IU l-1 (HR: 3.41, 95% Cl: 1.57-7.38, P = 0.002) together with PSA level at switch ≥50 ng ml-1 (HR: 2.59, 95% Cl: 1.22-5.47, P = 0.013) independently predicted poorer OS. Based on the predictive factors in multivariate analysis, we developed two risk stratification tools to select candidates for corticosteroid switching. Detection of serum ALP level, PSA level, and tissue AKR1C3 expression in mCRPC patients could help make clinical decisions for corticosteroid switching.

Humans , Male , Abiraterone Acetate/therapeutic use , Adrenal Cortex Hormones/therapeutic use , Androstenes , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Dexamethasone/therapeutic use , Disease-Free Survival , Prednisone/therapeutic use , Prostate-Specific Antigen , Prostatic Neoplasms, Castration-Resistant/pathology , Retrospective Studies , Treatment Outcome
Asian Journal of Andrology ; (6): 161-166, 2022.
Article in English | WPRIM | ID: wpr-928524


Ethnicity might be associated with treatment outcomes in advanced prostate cancer. This study aimed to evaluate the efficacy and safety of androgen deprivation therapy (ADT) combined with apalutamide in East Asians with metastatic castration-sensitive prostate cancer (mCSPC). The original phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) trial was conducted at 260 sites in 23 countries. This subgroup analysis included patients enrolled in 62 participating centers in China, Japan, and Korea. Radiographic progression-free survival (PFS), time to prostate-specific antigen (PSA) progression, and PSA changes from baseline were compared between groups in the East Asian population. The intent-to-treat East Asian population included 111 and 110 participants in the apalutamide and placebo groups, respectively. The 24-month radiographic PFS rates were 76.1% and 52.3% in the apalutamide and placebo groups, respectively (apalutamide vs placebo: hazard ratio [HR] = 0.506; 95% confidence interval [CI], 0.302-0.849; P = 0.009). Median time to PSA progression was more favorable with apalutamide than placebo (HR = 0.210; 95% CI, 0.124-0.357; P < 0.001). Median maximum percentages of PSA decline from baseline were 99.0% and 73.9% in the apalutamide and placebo groups, respectively. The most common adverse event (AE) was rash in the apalutamide group, with a higher rate than that in the placebo group (37.3% vs 9.1%). The most common grade 3 or 4 AEs were rash (12 [10.9%]) and hypertension (12 [10.9%]) for apalutamide. The efficacy and safety of apalutamide in the East Asian subgroup of the TITAN trial are consistent with the global results.

Humans , Male , Androgen Antagonists/adverse effects , Exanthema/chemically induced , Asia, Eastern , Prostate-Specific Antigen , Prostatic Neoplasms, Castration-Resistant/pathology , Thiohydantoins/adverse effects