ABSTRACT
Objective:To explore the feasibility of radical prostatectomy without biopsy for patients with highly suspected localized prostate cancer diagnosed by multiparametric magnetic resonance imaging (mpMRI) and 68Ga-PSMA PET/CT. Methods:Patients were enrolled in this single-arm prospective study from March 2019 to January 2022 in the Second Hospital of Tianjin Medical University. Eligible patients were aged ≤80 years with an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1. Based on mpMRI and 68Ga-PSMA PET/CT, patients were diagnosed with highly suspected localized prostate cancer with no evidence of distant lymphatic, bone or visceral metastases. Patients were excluded if they had obvious important organs dysfunction, suspected metastatic lesions or history of other malignant tumor. After fully informed of the surgical risks and possibilities of final pathology, patients received laparoscopic or robot-assisted laparoscopic radical prostatectomy. According to final pathological results, the diagnostic accuracy of mpMRI and 68Ga-PSMA PET/CT was evaluated. Pathological features were compared between low 68Ga-PSMA PET/CT maximum standardized uptake value (SUV max) group (SUV max<10) and high SUV max group (SUV max≥10). Baseline characteristics were compared between clinically significant prostate cancer (CsPCa) and clinically insignificant prostate cancer (cisPCa) + high grade prostatic intraepithelial neoplasia (HGPIN) patients. Additional analysis of the correlation between baseline parameters and different subgroups including pathological stage, ISUP grades and risk groups were performed in CsPCa patients. Results:31 patients were enrolled. Median age was 68 (ranging 48-79)years old. Median BMI was 25.6(ranging 21.9-31.4)kg/m 2. Median prostate specific antigen (PSA) was 23.5 (ranging 5.6-94.7)ng/ml. Median prostate volume was 37.6(ranging 16.2-127.9)ml. Median PSA density (PSAD) was 0.56(ranging 0.11-2.86)ng/ml 2. Fifteen cases were scored prostate imaging reporting and data system (PI-RADS) 4 and 16 cases were scored PI-RADS 5. Median 68Ga-PSMA PET/CT SUV max was 13.3 (ranging 4.6-36.7). All surgeries were successfully accomplished without open conversion. Median postoperative hospitalization time was 5 (ranging 4-7)d. No major complication occurred perioperatively. Recovery of urinary continence was within 6 months in all patients. According to the final pathological results, 1(3.2%) patient was confirmed with HGPIN. 30 (96.8%) patients were confirmed with adenocarcinoma, including 26 (86.7%) patients with CsPCa and 4(13.3%) patients with cisPCa. Among prostate cancer cases, the pathological stage of 11(36.7%) was T 2 and 19(63.3%) was T 3. Four(13.3%) cases were with ISUP grade 1, 7(23.3%) cases were with ISUP grade 2, 7(23.3%) cases were with ISUP grade 3 and 12 (40.0%) cases were with ISUP grade≥4.Two(6.7%) cases were in low risk group, 3(10.0%) cases were in intermediate risk group and 25 (83.3%) cases were in high risk group. Twelve(40.0%) patients had positive surgical margins. Standard pelvic lymph node dissection was carried out in 18 (17 prostate cancer and 1 HGPIN) cases. Sixty-two lymph nodes were dissected and none of them was positive. The diagnostic accuracy of mpMRI and 68Ga-PSMA PET/CT was 96.8%(30/31) in prostate cancer. Compared to low SUV max group, patients in high SUV max group had higher ISUP grade ( P=0.003) but there was no significant difference in positive surgical margin, seminal vesical invasion or pathological stage ( P>0.05). Among CsPCa patients, 10 (38.5%) cases were scored PI-RADS 4 and 16(61.5%) cases were scored PI-RADS 5. Median 68Ga-PSMA PET/CT SUV max was 14.3 (range 6.1-36.7). Compared to cisPCa and HGPIN patients, a smaller median prostate volume (34.3 vs. 73.0 ml, P=0.006), higher median PSAD (0.70 vs. 0.13 ng/ml 2, P=0.001), higher rates of PI-RADS 5 patients (61.5% vs. 0, P=0.018) and higher 68Ga-PSMA PET/CT SUV max (14.3 vs. 6.1, P=0.001) were found in CsPCa patients. Subgroup analysis showed no significant difference between SUV max and pathological stage (25.5 vs. 13.9), ISUP grades (15.4 vs. 14.4 vs. 14.0) and risk groups (9.7 vs. 14.9) in CsPCa patients ( P>0.05). Conclusions:The diagnostic accuracy of mpMRI and 68Ga-PSMA PET/CT is high in prostate cancer. With efficient communication, radical prostatectomy without biopsy for patients with highly suspected localized prostate cancer diagnosed by mpMRI and 68Ga-PSMA PET/CT is safe.
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Objective:To evaluate the efficacy and safety of docetaxel plus hormone therapy in metastatic prostate cancer.Methods:From April 2016 to April 2019, 204 cases with bone metastatic prostate cancer in the Second Hospital of Tianjin Medical University were analyzed retrospectively. There were 97 patients responded to hormone therapy including 92 cases with high-burden metastasis (more than 4 bone metastases with one or more beyond the axial skeleton) and 5 cases with low-burden metastasis, with average age of 70 years (range 42-87 years) and median prostate specific antigen (PSA) of 74.1 ng/ml (range 11.0-145.0 ng/ml). Among them, there were 35 patients (36.1%) with a Gleason score of 7 or lower, and 62 patients (63.9%) with a Gleason score of 8 or higher. There were 26 patients suffering from bone pain, with average numerical rating scales(NRS) score of 3.7. In addition, there were 107 patients being resistant to hormone therapy, with average age of 73 years (range 56-83 years), and median PSA of 84.5 ng/ml (range 12.4-490.2 ng/ml), including 32 patients (29.9%) with a Gleason score of 7 or lower, and 75 patients (70.1%) with a Gleason score of 8 or higher. Among them, there were 75 patients suffering from bone pain, with average NRS score of 5.4. All patients received continuous hormone therapy combined with docetaxel (at a dose of 75 mg per square meter of body-surface area every 3w, plus prednisone 5 mg twice a day), and PSA progression-free survival (PSA-PFS), NRS score, pain relief, and adverse events were analyzed. Additional analysis of the correlation between PSA-PFS and subgroups with age, PSA level and Gleason score were performed.Results:For patients with metastatic hormone sensitive prostate cancer (mHSPC), 6 (6.2%) cases only received 1-2 cycles of chemotherapy due to different reasons, and the others received 3-6 cycles(average 4.7)with the median follow-up of 15 months. Of patients who received ≥3 cycles, there were 36 cases presenting PSA progression, with the median PSA-PFS of 22 months, average NRS score decline from 3.9 to 3.0, and pain relief rate of 72.0%(18/25). For patients with metastatic castration-resistant prostate cancer (mCRPC), 9 (8.4%)cases only received 1-2 cycles of chemotherapy, and the others received 3-14 cycles (average 5.6). Of patients who received≥3 cycles, there were 51 cases with PSA progression, with the median PSA-PFS of 11 months, average NRS score decline from 5.6 to 4.4, and pain relief rate of 48.6%(35/72). Subgroup analysis showed a significant correlation between PSA level and PSA-PFS for patients with mCRPC( P=0.026). Age or Gleason score was not significantly correlated to PSA-PFS in mHSPC or mCRPC( P>0.05). For patients with mHSPC, grade 3 or 4 neutropenia occurred in 17 cases(17.5%), nausea and vomiting in 27 cases(27.8%), and fatigue in 25 cases(25.8%). For patients with mCRPC, grade 3 or 4 neutropenia occurred in 24 cases (22.4%), nausea and vomiting in 34 cases(31.8%), and fatigue in 26 cases(24.3%). Allergic reaction and sensory neuropathy toxicity were occasional. Conclusion:Efficacy of docetaxel plus hormone therapy was confirmed in metastatic prostate cancer and adverse events were tolerable.
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Objective:To investigate the correlation of preoperative peripheral lymphocyte-to-monocyte ratio(LMR)with the biochemical relapse and prognosis in prostate cancer(PCa)patients treated with endocrine therapy after radical prostatectomy(RP).Methods:Clinical data of 306 prostate cancer patients treated with endocrine therapy after radical prostatectomy were retrospectively analyzed in our hospital from June 2008 to June 2019.The end point of observation was biochemical relapse-free survival(RFS)in all patients receiving RP.The best cutoff value of preoperative LMR was calculated by receiver operating characteristic(ROC)curve.All patients were divided into the high LMR group(LMR≥2.8, n=93, 30.4%)and the low LMR group(LMR<2.8, n=213, 69.6%). The differences in clinical indicators of PCa were compared between high and low LMR groups.CoX regression model on the risk ratio of single and multiple factors were used to analyze the survival effect of preoperative LMR on the prognosis of PCa patients undergoing endocrine therapy after operation.Results:The median follow-up time was ranged from 4 to 132 months.The area under the ROC curve of LMR was 0.582(95% CI: 0.511-0.652, P<0.05), and the cutoff value of the preoperative LMR was 2.8, which was significantly associated with clinical T stage( P=0.023)and lymphatic metastasis( P=0.031). Kaplan-Meier analysis demonstrated that the low LMR group had a short RFS and a poor prognosis(31.0 months vs.38.5 months)than those in the high LMR group( P<0.05). Lymphatic metastasis and preoperative LMR were independent predictors for RFS in PCa patients treated with endocrine therapy after radical prostatectomy. Conclusions:Preoperative peripheral LMR can be used as an auxiliary indicator of the prognosis in PCa patients treated with endocrine therapy after radical prostatectomy.
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Objective:To investigate the correlation between chronic inflammation and biopsy results in the first prostate biopsy and the predictive effect of chronic inflammation on the results of repeated prostate biopsy.Method:From January 2016 to January 2019, 771 patients who underwent transperineal prostate biopsy for the first time in the Second Hospital of Tianjin Medical University were included. The average age was 69.6 years old(39-89), with PSA level of 16.1 ng/ml(4-50), PSAD level of 0.6 ng/ml 2(0.1-1.3), prostate volume(PV)of 40.2 ml(16.7-129.5), transition zone volume(TZ) of 23.9 ml(0.7-49.5). The biopsy was performed under general anesthesia in the lithotomy position, and transrectal ultrasound(TRUS)and prostate puncture template were used to guide the biopsy. The association between chronic inflammation and pathological results or Gleason scores in prostate cancer (PCa) were analyzed. The univariate and multivariate logistic regression analyses were performed to select the independent risk factors for prostate biopsy results. The relationship between chronic inflammation and pathological results in patients with repeated biopsy within 3 years after the first biopsy was assessed. The independent risk factors related to the results of the repeated biopsy were also evaluated. Result:A total of 771 patients were included, including 354 cases of PCa and 144(40.7%) cases associated with chronic inflammation. In addition, 332 cases were benign prostatic disease (BPD), including 263(79.2%) cases with chronic inflammation, and 85 cases were prostate high-grade intraepithelial neoplasia group (HGPIN), including 13(15.3%) cases with chronic inflammation. The PV, TZ and chronic inflammation rates were statistically significantly lower in PCa and HGPIN than those in BPD, while the level of PSA and PSAD were significantly higher than those in BPD. Multivariate logistics regression analysis showed that PSAD and chronic inflammation rates were independent risk factors for PCa and HGPIN. According to the biopsy results of Gleason score from 6 to 10, the chronic inflammation rates was 70%(35/50), 61%(36/59), 33%(69/209), 12%(3/25) and 9%(1/11) respectively ( P<0.05), which indicated that the chronic inflammation was negatively correlated with higher grade tumors. The repeated biopsy was performed in 30 patients within 3 years after the first biopsy. The average age was 71.2 years old (45-80), with PSA level of 20.1 ng/ml (4-39), PSAD level of 0.7 ng/ml 2(0.2-1.3), PV of 39.3 ml(18.5-119.0), and TZ of 19.9 ml(12.5-40.5). The results of the repeated biopsy showed that there were 9 cases with PCa(3 cases with chronic inflammation)and 21 cases without PCa (16 cases with chronic inflammation). The level of PSA ( P=0.031) and PSAD ( P=0.032) were statistically significantly higher in PCa than those in benign disease, while the chronic inflammation rates were significantly lower than those in benign disease( P=0.042). Multivariate logistics regression analysis showed that PSAD ( OR=0.7, P=0.012) and chronic inflammation( OR=13.7, P<0.001)were independent risk factors in the positive repeated biopsy. In patients with repeated biopsy, considering PSAD (cut off value 0.15) and first biopsy with chronic inflammation, the predicted results were positive in 8 cases and negative in 22 cases. The real number of cases in the two groups is 6 and 19 respectively. The sensitivity, specificity, positive predictive value, and negative predictive value of repeated biopsy results were 66.7%, 90.4%, 75.0%, and 86.3%, respectively. Conclusion:Chronic inflammation was negatively correlated with positive biopsy results and high-grade tumors. For the patients with PSAD<0.15 and the first biopsy with chronic inflammation, the repeated biopsy should be avoided in most of the cases.