Prevalence of bilateral loco-regional spread in unilateral pelvic PSMA PET positive recurrent prostate cancer.

BACKGROUND: Defining the best surgical template for salvage lymph node dissection (SLND) in patients exhibiting unilateral prostate cancer (PCa) recurrence in pelvic lymph nodes (LNs) is an unmet need. We assessed the risk of missing contralateral nodal recurrence in patients with unilateral positive PSMA-PET who were treated with bilateral PSMA-radioguided (RGS) SLND. METHODS: Patients who consecutively underwent bilateral PSMA-radioguided SLND for PCa recurrence between April 2014 and January 2023 were identified. We compared PSMA PET findings with the number and the location of PCa LN metastases of the final pathological report. Univariable logistic regression models to try to predict contralateral missed disease were performed. RESULTS: Sixty patients were identified. At PSMA-RGS, the median PSA level was 0.71 ng/mL (IQR: 0.38-2.28). At PSMA-PET pre-SLND, 49 (82%) patients had unilateral exclusively pelvic lesions, 2 (3%) had unilateral positive nodes at the level of the common iliac arteries, and 9 (15%) had unilateral positive nodes in both levels. Final pathology revealed unilateral LN involvement in 43 (72%), a negative report in 3 (5%), and bilateral positive lesions in 14 (23%) patients. In the univariable logistic regression models, none of the tested factors showed influence on missing contralateral lesions. Four patients out of 35 (11%) with one positive LN at PSMA-PET had bilateral PCa recurrence. CONCLUSIONS: Patients with one-sided positive LNs on PSMA PET can be considered for a unilateral PSMA-radioguided SLND template with the caveat that about a quarter of patients ultimately have bilateral positive LNs. Larger prospective randomized trials are needed to confirm our findings.

PROPOSe: A Real-life Prospective Study of Proclarix, a Novel Blood-based Test to Support Challenging Biopsy Decision-making in Prostate Cancer.

BACKGROUND: Prostate-specific antigen (PSA)-based detection of prostate cancer (PCa) often leads to negative biopsy results or detection of clinically insignificant PCa, more frequently in the PSA range of 2-10 ng/ml, in men with increased prostate volume and normal digital rectal examination (DRE). OBJECTIVE: This study evaluated the accuracy of Proclarix, a novel blood-based diagnostic test, to help in biopsy decision-making in this challenging patient population. DESIGN, SETTING, AND PARTICIPANTS: Ten clinical sites prospectively enrolled 457 men presenting for prostate biopsy with PSA between 2 and 10 ng/ml, normal DRE, and prostate volume ≥35 cm3. Transrectal ultrasound-guided and multiparametric magnetic resonance imaging (mpMRI)-guided biopsy techniques were allowed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Serum samples were tested blindly at the end of the study. Diagnostic performance of Proclarix risk score was established in correlation to systematic biopsy outcome and its performance compared with %free PSA (%fPSA) and the European Randomised Study of Screening for Prostate Cancer (ERSPC) risk calculator (RC) as well as Proclarix density compared with PSA density in men undergoing mpMRI. RESULTS AND LIMITATIONS: The sensitivity of Proclarix risk score for clinically significant PCa (csPCa) defined as grade group (GG) ≥2 was 91% (n = 362), with higher specificity than both %fPSA (22% vs 14%; difference = 8% [95% confidence interval {CI}, 2.6-14%], p = 0.005) and RC (22% vs 15%; difference = 7% [95% CI, 0.7-12%], p = 0.028). In the subset of men undergoing mpMRI-fusion biopsy (n = 121), the specificity of Proclarix risk score was significantly higher than PSA density (26% vs 8%; difference = 18% [95% CI, 7-28%], p < 0.001), and at equal sensitivity of 97%, Proclarix density had an even higher specificity of 33% [95% CI, 23-43%]. CONCLUSIONS: In a routine use setting, Proclarix accurately discriminated csPCa from no or insignificant PCa in the most challenging patients. Proclarix represents a valuable rule-out test in the diagnostic algorithm for PCa, alone or in combination with mpMRI. PATIENT SUMMARY: Proclarix is a novel blood-based test with the potential to accurately rule out clinically significant prostate cancer, and therefore to reduce the number of unneeded biopsies.

Shear wave elastography for localization of prostate cancer lesions and assessment of elasticity thresholds: implications for targeted biopsies and active surveillance protocols.

PURPOSE: Shear wave elastography allows the detection of cancer by using focused ultrasound pulses for locally deforming tissue. The differences in tissue elasticity and stiffness have been used increasingly in breast cancer imaging and help detect potential tumor lesions in the prostate. In this study we localized prostate cancer lesions using shear wave elastography before radical prostatectomy and assessed the examiner independent elasticity threshold for cancer foci detection. MATERIALS AND METHODS: Shear wave elastography scanning of the whole prostate was performed before radical prostatectomy in 60 consecutive patients with high, intermediate and low risk disease. Localization of suspected lesions and density threshold (kPa) were recorded in up to 12 areas and resulted in 703 different fields. Shear wave elastography findings were correlated with final pathology. Initially 381 areas were used to establish shear wave elastography cutoffs (development cohort 32 patients). Subsequently these cutoffs were validated in 322 areas (validation cohort 28 patients). RESULTS: Using shear wave elastography significant differences were recorded for the elasticity of benign tissue vs prostate cancer nodules at 42 kPa (range 29 to 71.3) vs 88 kPa (range 54 to 132) (all p <0.001). Median cancer lesion diameter was 26 mm (range 18 to 41). Applying the most informative cutoff of 50 kPa to the validation cohort resulted in 80.9% and 69.1% sensitivity and specificity, respectively, and 74.2% accuracy for detecting cancer nodules based on final pathological finding. The corresponding positive and negative predictive values were 67.1% and 82.2%, respectively. CONCLUSIONS: Shear wave elastography allows the identification of cancer foci based on shear wave elastography differences. Moreover, reliable cutoffs for this approach can be established, allowing examiner independent localization of prostate cancer foci.

Functional and oncological outcomes of patients aged <50 years treated with radical prostatectomy for localised prostate cancer in a European population.

OBJECTIVE: To address the biochemical and functional outcomes after radical prostatectomy (RP) of men aged <50 years in a large European population. PATIENTS AND METHODS: Among 13,268 patients who underwent RP for clinically localised prostate cancer at our centre (1992-2011), 443 (3.3%) men aged <50 were identified. Biochemical recurrence (BCR) and functional outcomes (International Index of Erectile Function [IIEF-5], use of pads), were prospectively evaluated and compared between men aged <50 years and older patients. RESULTS: Men aged <50 years were more likely to harbour D'Amico low-risk (49.4 vs 34.9%, P < 0.001), organ-confined (82.6 vs 69.4%, P < 0.001) and low-grade tumours (Gleason score <7: 33.1 vs 28.7%, P < 0.001). Multivariate Cox regression analysis showed that age <50 years (hazard ratio 0.99; confidence interval 0.72-1.31; P = 0.9) was not a predictor of BCR. Urinary continence was more favourable in younger patients, resulting in continence rates of 97.4% vs 91.6% in most recent years (2009-2011) for patients aged <50 vs ≥50 years. After RP, a median IIEF-5 drop of 4 points in younger men vs 8 points in older patients was recorded (P < 0.001). Favourable recovery of urinary continence and erectile function in patients aged <50 years compared with their older counterparts was confirmed after multivariable adjustment. CONCLUSION: Men aged <50 years diagnosed with localised prostate cancer should not be discouraged from RP, as the postoperative rates of urinary incontinence and erectile dysfunction are low and probability of BCR-free survival at 2 and 5 years is high.

Gleason 6 prostate cancer in one or two biopsy cores can harbor more aggressive disease.

BACKGROUND AND PURPOSE: Patients with Gleason (GL) 6 prostate cancer in one or two biopsy cores can be upgraded and/or upstaged at the time of surgery, which may adversely impact long-term outcome. A novel model for prediction of adverse pathologic outcomes was developed using preoperative characteristics. PATIENTS AND METHODS: Between 2003 and 2007, 1159 patients underwent robot-assisted radical prostatectomy (RARP) at our institution. GL 6 prostate cancer in one or two biopsy cores was identified in 416 (36%) patients. Logistic regression analyses were used to assess the rate of GL ≥7 and/or extraprostatic extension at RARP. Covariates consisted of age, body mass index (BMI), number of positive cores, greatest percent of cancer in a core (GPC), clinical stage, and preoperative prostate-specific antigen (PSA) level. After backward variable selection, the developed model was internally validated using the area under the curve and subjected to methods of calibration. RESULTS: Respectively, 278 (67%) and 138 (33%) patients had one or two positive biopsy cores. At RARP, 90 (22%) patients were upgraded to GL ≥7 and 37 (9%) had extraprostatic extension. The novel model relied on age, BMI, preoperative PSA level, and GPC for prediction of adverse pathologic outcomes and was 69% accurate. Calibration plot revealed a virtually perfect relationship between predicted and observed probabilities. CONCLUSIONS: In patients with GL 6 prostate cancer in one or two biopsy cores, 25% have more ominous pathology at RARP. The model provides an individual assessment of adverse outcomes at surgery. Consequently, it may be considered when counseling patients regarding their management options.

Importance of baseline potency rate assessment of men diagnosed with clinically localized prostate cancer prior to radical prostatectomy.

INTRODUCTION: Erectile dysfunction (ED) is a common, and multifactorial medical problem with significant impact on quality of life. Knowledge about baseline potency is highly important in men undergoing treatment for prostate cancer (PCa) as it might influence judgments about impact of treatment and thereby treatment decisions. AIMS: To analyze the baseline potency rate of men with clinically localized PCa prior to radical prostatectomy (RP). Furthermore, it was of interest to identify comorbid factors of preoperative ED. MAIN OUTCOME MEASURE: Prevalence of preoperative ED and association between comorbidities and ED in men prior to RP in bi- and multivariable logistic regression analyses. METHODS: Retrospective analysis of a large single center cohort of 1,330 evaluable PCa patients who were preoperatively assessed with the abridged 5-item version of the International Index of Erectile Function (IIEF) also described as Sexual Health Inventory for Men. Baseline potency and comorbidity rates, and their distribution were described. The risk of baseline ED associated with age, body mass index (BMI), the presence of hyperlipoproteinemia (HLP), non-insulin-dependent diabetes mellitus (NIDDM), hypertension, and depression were analyzed in bi- and multivariable logistic regression analyses. RESULTS: Using the IIEF-5 cutoff value of 21, 48% demonstrated some degree of ED. Severe, moderate, mild to moderate, mild, and no ED was observed in 9.2, 4.0, 10.2, 24.7, and 52% respectively. In univariable analyses, ED significantly increased according to increasing age, BMI, presence of HLP, hypertension, NIDDM, and depression (P