Addressing racial disparities in prostate cancer pathology prediction models: external validation and comparison of four models of pathological outcome prediction before radical prostatectomy in the multiethnic SEARCH cohort.

BACKGROUND: Certain widely used pathological outcome prediction models that were developed in tertiary centers tend to overpredict outcomes in the community setting; thus, the Michigan Urological-Surgery Improvement Collaborative (MUSIC) model was developed in general urology practice to address this issue. Additionally, the development of these models involved a relatively small proportion of Black men, potentially compromising the accuracy of predictions in this patient group. We tested the validity of the MUSIC and three widely used nomograms to compare their overall and race-stratified predictive performance. METHODS: We extracted data from 4139 (1138 Black) men from the Shared Equal Access Regional Cancer Hospital (SEARCH) database of the Veterans Affairs health system. The predictive performance of the MUSIC model was compared to the Memorial-Sloan Kettering (MSK), Briganti-2012, and Partin-2017 models for predicting lymph-node invasion (LNI), extra-prostatic extension (EPE), and seminal vesicle invasion (SVI). RESULTS: The median PSA of Black men was higher than White men (7.8 vs. 6.8 ng/ml), although they were younger by a median of three years and presented at a lower-stage disease. MUSIC model showed comparable discriminatory capacity (AUC:77.0%) compared to MSK (79.2%), Partin-2017 (74.6%), and Briganti-2012 (76.3%), with better calibration for LNI. AUCs for EPE and SVI were 72.7% and 76.9%, respectively, all comparable to the MSK and Partin models. LNI AUCs for Black and White men were 69.6% and 79.6%, respectively, while EPE and SVI AUCs were comparable between races. EPE and LNI had worse calibration in Black men. Decision curve analysis showed MUSIC superiority over the MSK model in predicting LNI, especially among Black men. CONCLUSION: Although the discriminatory performance of all models was comparable for each outcome, the MUSIC model exhibited superior net benefit to the MSK model in predicting LNI outcomes among Black men in the SEARCH population.

Urinary volatile organic compounds in prostate cancer biopsy pathologic risk stratification using logistic regression and multivariate analysis models.

Prostate cancer (PCa) is the second leading cause of cancer-related death in American men after lung cancer. The current PCa diagnostic method, the serum prostate-specific antigen (PSA) test, is not specific, thus, alternatives are needed to avoid unnecessary biopsies and over-diagnosis of clinically insignificant PCa. To explore the application of metabolomics in such effort, urine samples were collected from 386 male adults aged 44-93 years, including 247 patients with biopsy-proven PCa and 139 with biopsy-proven negative results. The PCa-positive group was further subdivided into two groups: low-grade (ISUP Grade Group = 1; n = 139) and intermediate/high-grade (ISUP Grade Group ≥ 2; n = 108). Volatile organic compounds (VOCs) in urine were extracted by stir bar sorptive extraction (SBSE) and analyzed using thermal desorption with gas chromatography and mass spectrometry (GC-MS). We used machine learning tools to develop and evaluate models for PCa diagnosis and prognosis. In total, 22,538 VOCs were identified in the urine samples. With regularized logistic regression, our model for PCa diagnosis yielded an area under the curve (AUC) of 0.99 and 0.88 for the training and testing sets respectively. Furthermore, the model for differentiating between low-grade and intermediate/high-grade PCa yielded an average AUC of 0.78 based on a repeated test-sample approach for cross-validation. These novel methods using urinary VOCs and logistic regression were developed to fill gaps in PCa screening and assessment of PCa grades prior to biopsy. Our study findings provide a promising alternative or adjunct to current PCa screening and diagnostic methods to better target patients for biopsy and mitigate the challenges associated with over-diagnosis and over-treatment of PCa.

Urinary fatty acid biomarkers for prostate cancer detection.

The lack of accuracy in the current prostate specific antigen (PSA) test for prostate cancer (PCa) screening causes around 60-75% of unnecessary prostate biopsies. Therefore, alternative diagnostic methods that have better accuracy and can prevent over-diagnosis of PCa are needed. Researchers have examined various potential biomarkers for PCa, and of those fatty acids (FAs) markers have received special attention due to their role in cancer metabolomics. It has been noted that PCa metabolism prefers FAs over glucose substrates for continued rapid proliferation. Hence, we proposed using a urinary FAs based model as a non-invasive alternative for PCa detection. Urine samples collected from 334 biopsy-designated PCa positive and 232 biopsy-designated PCa negative subjects were analyzed for FAs and lipid related compounds by stir bar sorptive extraction coupled with gas chromatography/mass spectrometry (SBSE-GC/MS). The dataset was split into the training (70%) and testing (30%) sets to develop and validate logit models and repeated for 100 runs of random data partitioning. Over the 100 runs, we confirmed the stability of the models and obtained optimal tuning parameters for developing the final FA based model. A PSA model using the values of the patients' PSA test results was constructed with the same cohort for the purpose of comparing the performances of the FA model against PSA test. The FA final model selected 20 FAs and rendered an AUC of 0.71 (95% CI = 0.67-0.75, sensitivity = 0.48, and specificity = 0.83). In comparison, the PSA model performed with an AUC of 0.51 (95% CI = 0.46-0.66, sensitivity = 0.44, and specificity = 0.71). The study supports the potential use of urinary FAs as a stable and non-invasive alternative test for PCa diagnosis.

Intratumoural immunotherapy plus focal thermal ablation for localized prostate cancer.

Major advances have been made in the use of immunotherapy for the treatment of solid tumours, including the use of intratumourally injected immunotherapy instead of systemically delivered immunotherapy. The success of immunotherapy in prostate cancer treatment has been limited to specific populations with advanced disease, which is thought to be a result of prostate cancer being an immunologically 'cold' cancer. Accordingly, combining intratumoural immunotherapy with other treatments that would increase the immunological heat of prostate cancer is of interest. Thermal ablation therapy is currently one of the main strategies used for the treatment of localized prostate cancer and it causes immunological activation against prostate tissue. The use of intratumoural immunotherapy as an adjunct to thermal ablation offers the potential to elicit a systemic and lasting adaptive immune response to cancer-specific antigens, leading to a synergistic effect of combination therapy. The combination of thermal ablation and immunotherapy is currently in the early stages of investigation for the treatment of multiple solid tumour types, and the potential for this combination therapy to also offer benefit to prostate cancer patients is exciting.

Evaluation of Recurrent Disease after Radiation Therapy for Patients Considering Local Salvage Therapy: Past vs. Contemporary Management.

Recurrent prostate cancer after primary treatment with radiation therapy is a common problem. Patients with localized recurrence may benefit from salvage therapy, but careful patient selection is crucial because not all patients will benefit from local salvage therapy, and salvage therapy has increased morbidity compared to primary treatments for prostate cancer. This review aims to provide an overview of the evaluation of patients with recurrent disease after radiation therapy and how it is continuing to evolve with increasing data on outcomes, as well as improving technologies and techniques. Our enhanced understanding of treatment outcomes and risk stratification has influenced the identification of patients who may benefit from local salvage treatment. Advances in imaging and biopsy techniques have enhanced the accuracy of locating the recurrence, which affects treatment decisions. Additionally, the growing interest in image-targeted ablative therapies that have less morbidity and complications than whole-gland therapies for suitable patients influences the evaluation process for those considering focal salvage therapy. Although significant changes have been made in the diagnostic evaluation of patients with recurrent disease after radiation therapy, it remains unclear whether these changes will ultimately improve patient outcomes.

Comparison of procedural anxiety and pain associated with conventional transrectal ultrasound prostate biopsy to magnetic resonance imaging-ultrasound fusion-guided biopsy: a prospective cohort trial.

BACKGROUND: Prostate cancer (PCa) diagnosis relies on biopsies, with transrectal ultrasound (TRUS) biopsies being common. Fusion biopsy (FB) offers improved diagnostic accuracy, but the pain and anxiety experienced by patients during biopsies is often overlooked. This study aims to compare pain and anxiety levels between standard TRUS-guided biopsy (STB) and systematic plus MRI/US fusion biopsy (STB + FB). MATERIALS AND METHODS: The study involved adult men undergoing biopsies, receiving identical peri-procedural care, including 2% lidocaine jelly in the rectum and subsequent 1% lidocaine injections (10cc per side) into the prostate-seminal vesicle junction and prostatic apical areas bilaterally. The biopsy technique was chosen based on clinical and imaging findings. Pre- and post-biopsy anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, categorized as mild (20-37), moderate (38-44), or severe (45-80). Post-biopsy pain was evaluated on a numerical rating scale, ranging from 0 to 10. RESULTS: Of the 165 patients, 99 underwent STB, and 66 underwent STB + FB. No significant differences were observed in age, race, prostate-specific antigen, prostate volume, or prior biopsies between the groups. The STB + FB group had more biopsy cores taken (16.2 vs. 12, p = 0.001) and a longer procedure time (23 vs. 10 min, p = 0.001). STB biopsy patients experienced lower post-procedural anxiety compared to STB + FB, with a mean difference of -7 (p = 0.001, d = 0.92). In the STB + FB group, 89% experienced severe post-procedural anxiety compared to 59% in STB (p = 0.002). There was no significant difference in post-procedural pain (p = 0.7). Patients with prior biopsies had significantly higher STAI(S) anxiety scores (p = 0.005), and the number of prior biopsies correlated with anxiety severity (p = 0.04) in STB + FB group. CONCLUSION: In summary, STB + FB group demonstrated higher post-procedural anxiety levels than the STB group, with no difference in pain levels. Additionally, patients with a history of repeat biopsies were more likely to exhibit higher STAI(S) anxiety scores.

Surveillance one year post focal cryotherapy for clinically significant prostate cancer using mpMRI and PIRADS v2.1: An initial experience from a prospective phase II mandatory biopsy study.

Objectives: Multiparametric magnetic resonance imaging (mpMRI) surveillance post focal cryotherapy (FT) of prostate cancer is challenging as post treatment artefacts alter mpMRI findings. In this initial experience, we assessed diagnostic performance of mpMRI in detecting clinically significant prostate cancer (csPCa) after FT. Materials and methods: This single-centre phase II prospective clinical trial recruited 28 men with localized csPCa for FT between October 2019 and April 2021. 12-months post FT mpMRI were performed prior to biopsy and sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of all mpMRI positive subjects were analysed. Chi square goodness of fit test correlated biopsy positive PIRADS3 (P3) and PIRADS4/5 lesions with histology grade group. One way ANOVA test assessed performance of ADC values in differentiating csPCa, non csPCa and benign lesions. Results: Sensitivity, specificity, PPV and NPV of mpMRI were 100%, 14.28%, 53.84% and 100% for subjects with histologically proven cancer. Correlation of PIRADS v2.1 scores with histologically proven prostate cancer was statistically significant (p < 0.5). Correlation of P3 lesions with non-csPCa was statistically significant (p < 0.02535). Higher ADC value was associated with benign histology (adjusted odds ratio OR 0.97, 95% confidence interval: 0.94, 0.99) (p = 0.008). Among the malignant lesions, higher ADC value was associated with non-csPCa (adjusted OR: 0.97; 95% CI: 0.95, 0.99) (p = 0.032). Conclusion: mpMRI is highly sensitive in detecting residual cancer. ADC values and PIRADS scores may be of value in differentiating csPCa from non-csPCa with a potential for risk stratification of men requiring re-biopsy versus non-invasive surveillance of remnant prostate.

Salvage Cryoablation for Recurrent Prostate Cancer Following Primary External Beam Radiotherapy or Primary Cryotherapy: A Propensity Score Matched Analysis of Mid-term Oncologic and Functional Outcomes.

INTRODUCTION: Local prostate cancer recurrence following radiotherapy (XRT) or cryoablation (CRYO) may be addressed with salvage cryotherapy (SCT), although little is known about how the primary treatment modality affects SCT results. Oncologic and functional outcomes of patients who underwent SCT after primary XRT (XRT-SCT) or cryoablation (CRYO-SCT) were studied. METHODS: Data was collected using the Duke Prostate Cancer database and the Cryo On-Line Data (COLD) registry. The primary outcome was biochemical progression-free survival (BPFS).  Urinary incontinence, rectourethral fistula, and erectile dysfunction were secondary outcomes. The Kaplan-Meier log-rank test and univariable/multivariable Cox proportional hazards (CPH) models were utilized to evaluate BPFS between groups. RESULTS: 419 XRT-SCT and 63 CRYO-SCT patients met inclusion criteria, that was reduced to 63 patients in each cohort after propensity matching. There was no difference in BPFS at 2 and 5 years both before (P = .5 and P = .7) and after matching (P = .6 and P = .3). On multivariable CPH, BPFS was comparable between treatment groups (CRYO-SCT, HR=1.1, [0.2-2.2]).  On the same analysis, BPFS was lower in D'Amico high-risk (HR 3.2, P < .01) and intermediate-risk (HR 1.95, P < .05) categories compared to low-risk. There was no significant difference in functional outcomes between cohorts. CONCLUSION: Following primary cryotherapy, salvage cryoablation provides comparable intermediate oncological outcomes and functional outcomes compared to primary radiotherapy.

Intermediate-term oncological and functional outcomes of salvage cryotherapy for the management of prostate cancer recurrence after primary brachytherapy versus primary cryotherapy: A propensity score-matched analysis.

BACKGROUND: Salvage cryotherapy (SCT) is widely used to treat prostate cancer (PCa) recurrence after radiotherapy (RT). We studied the intermediate oncological and functional outcomes of patients who underwent SCT following cryotherapy (CRYO-SCT) recurrence and compare it to recurrence after brachytherapy (BT-SCT). METHODS: An IRB-approved retrospective cohort study utilizing patient data from the Cryo On-Line Data Registry and the Duke PCa database between 1992 and 2016. Biochemical recurrence (BCR) using Phoenix criteria was the primary endpoint assessed at 2- and 5-years post-SCT. Secondary endpoints assessed functional outcomes including urinary continence, erectile function, and recto-urethral fistula. Association between treatment and biochemical progression-free survival was assessed using inverse probability weighted (IPTW) Cox proportional hazards regression. The differences in the secondary functional outcomes were assessed by Pearson's χ2 test or Fisher's exact test, corrected for IPTW. RESULTS: A total of 194 patients met inclusion criteria. The BCR rate for BT-SCT and CRYO-SCT was 23 (20.4%) and 17 (21%) at 2 years and 30 (26.5%) and 22 (27.2%) at 5 years according to Phoenix criteria. There was no statistical difference in 2 years (hazard ratio [HR] 0.9; 95% confidence interval [CI], 0.5-1.7, p = 0.7) or 5-year BCR (HR: 0.86; 95% CI, 0.5-1.5, p = 0.6) between the groups. The functional outcomes like urinary continence (p = 0.4), erectile function (p = 0.1), and recto-urethral fistula (p = 0.3) were not statistically different. CONCLUSION: CRYO-SCT appears to be well tolerated, with comparable oncological and functional outcomes to patients failing primary BT. The findings also demonstrated that SCT can render a significant number of patients biochemically free of disease after initial CRYO with minimal morbidity. SCT is a viable treatment option to salvage local PCa recurrence following either BT or cryoablation failure.

Reconciling discordance between PI-RADS 4 lesions and targeted biopsy: Early experience of a multidisciplinary quality improvement protocol with PI-RADS 4 subcategorization.

PURPOSE: PI-RADS 4 lesions are considered to have a "high" likelihood of clinically-significant prostate cancer (csPCa). However, patients undergoing targeted biopsy have a range of histologic findings. Understanding discordant cases is critical to improve diagnostic accuracy and inform subsequent management. We studied early findings from implementation of a multidisciplinary Quality Improvement (QI) protocol for reconciling discordance and evaluate the potential heterogeneity of PI-RADS 4. METHODS: Patients with mpMRI PI-RADS 4 lesions undergoing fusion-targeted biopsy from January 2017 to May 2021 were retrospectively reviewed. The discordant targeted biopsy pathology (benign/GG1) was evaluated utilizing a QI protocol and all lesions were subcategorized based on ADC values. Positive Predictive Value (PPV) for PI-RADS 4 lesions overall and the Cancer Detection Rate (CDR) for subcategorized lesions were calculated. RESULTS: 248 patients with 286 lesions were reviewed. Prior to re-review, PI-RADS 4 PPV for ≥ GG1 and ≥ GG2 lesions were 0.55 and 0.34, increasing to 0.67 and 0.43 following reconciliation. Lesion subcategorization based on ADC value as higher suspicion (4+) and lower suspicion (4-) resulted in 158 and 117 lesions, with reverse-fusion analysis revealing that 61% and 17% of lesions contained csPCa, respectively. Subgroup analysis among PI-RADS 4+ lesions led to an increase in the CDR to 75% and 61% for ≥ GG1 and ≥ GG2. CONCLUSION: Use of multidisciplinary QI protocol to review discordance cases of PI-RADS 4 improves diagnostic accuracy and guides subsequent management. Our findings highlight the known heterogeneity of this category with reference to csPCa CDR, suggesting the potential value of PI-RADS 4 subcategorization.

Clinical utility of multiple secondary combined tests in prostate cancer screening.

INTRODUCTION: The clinical utility of concurrent Prostate Health Index (PHI) and ExosomeDx Prostate Intelliscore (EPI) testing is unclear. We sought to examine the performance of combined PHI and EPI testing on men undergoing elevated PSA work up. MATERIALS AND METHODS: Patients who received both EPI and PHI testing were identified from an institutional database of men referred to urology for an elevated total PSA. Cut points of EPI > 15.6 and PHI ≥ 36 were used to denote a positive test. Patients were placed into one of four groups determined by combination of EPI and PHI results. Demographic variables and biopsy recommendations were compared between groups. The concordance of test positivity between EPI and PHI was compared by Cohen's kappa. Demographic variables and secondary testing results were compared between patients' compliant and non-compliant with prostate biopsy recommendation. Biopsy pathology was compared between groups. RESULTS: A total of 162 patients had both EPI and PHI testing. Median age was 65 years, with a median PSA of 6.64 ng/mL. Age (p = 0.001), PSA (< 0.001) and biopsy recommendation (< 0.001) differed between combined secondary screening test result groups. Seventy-five percent of patients with both a positive EPI and PHI were found to have prostate cancer, with 54.2% being ≥ Gleason 7. Cohen's kappa was 0.19, indicating poor concordance. The AUC of EPI and PHI for clinically significant cancer was 0.563 (95% CI: 0.4331-0.6923) and 0.685 (95% CI: 0.569-0.8) (p = 0.147). CONCLUSIONS: Concurrently positive EPI and PHI indicate increased prostate cancer risk, with combined usage potentially influencing biopsy recommendation and compliance.

Combined ARFI and Shear Wave Imaging of Prostate Cancer: Optimizing Beam Sequences and Parameter Reconstruction Approaches.

This study demonstrates the implementation of a shear wave reconstruction algorithm that enables concurrent acoustic radiation force impulse (ARFI) imaging and shear wave elasticity imaging (SWEI) of prostate cancer and zonal anatomy. The combined ARFI/SWEI sequence uses closely spaced push beams across the lateral field of view and simultaneously tracks both on-axis (within the region of excitation) and off-axis (laterally offset from the excitation) after each push beam. Using a large number of push beams across the lateral field of view enables the collection of higher signal-to-noise ratio (SNR) shear wave data to reconstruct the SWEI volume than is typically acquired. The shear wave arrival times were determined with cross-correlation of shear wave velocity signals in two dimensions after 3-D directional filtering to remove reflection artifacts. To combine data from serially interrogated lateral push locations, arrival times from different pushes were aligned by estimating the shear wave propagation time between push locations. Shear wave data acquired in an elasticity lesion phantom and reconstructed using this algorithm demonstrate benefits to contrast-to-noise ratio (CNR) with increased push beam density and 3-D directional filtering. Increasing the push beam spacing from 0.3 to 11.6 mm (typical for commercial SWEI systems) resulted in a 53% decrease in CNR. In human in vivo data, this imaging approach enabled high CNR (1.61-1.86) imaging of histologically-confirmed prostate cancer. The in vivo images had improved spatial resolution and CNR and fewer reflection artifacts as a result of the high push beam density, the high shear wave SNR, the use of multidimensional directional filtering, and the combination of shear wave data from different push beams.

A Comprehensive Assessment of the Utility of Transperineal Template Prostate Mapping Biopsy: A 13-year Experience.

OBJECTIVE: To assess Duke's experience on the utility of transperineal template mapping biopsy (TTMB) for re-evaluating patients with persistently elevated prostate-specific antigen after prior negative biopsy, with pre-existing prostate cancer (PCa) already on active surveillance (AS), or considering focal therapy (FT). METHODS: We retrospectively reviewed Duke patients undergoing TTMB. Functional outcomes were evaluated using International Index of Erectile Function-5 (IIEF-5) and International Prostate Symptom Score (IPSS). Complications within 30 days were recorded. Nonparametric statistical analyses compared functional measures from baseline to 2 and 6 weeks post-TTMB. RESULTS: From 8/2009 to 1/2021, 218 patients underwent TTMB, with 57-month median follow-up. Complication rate was 17.4%, with the majority Clavien I. Overall PCa detection was 72.9%, with clinically significant PCa in 53.2%; for those without prior PCa diagnosis (n = 117), overall detection was 64.1% with clinically significant PCa in 49.5%. Of those on AS at TTMB (n = 86), 36 (41.8%) had Gleason upgrading. TTMB changed management for 59 (68.6%) patients, with 38 (44.2%) proceeding to whole-gland therapy and 21 (24.4%) electing FT. Regarding functional outcomes, IPSS were insignificantly different from baseline at 6 weeks (P = NS). Overall functional score impacts were minimal across subgroups; in groups with significant declines in IIEF-5, median score drops were ≤1 point and caused minimal/no movement in IIEF-5 scoring category. CONCLUSION: In this cohort, TTMB offered enhanced cancer detection with overall minimal impact to functional outcomes. We conclude from this comprehensive assessment that TTMB provides value to rule out PCa, prevent overtreatment of those that can remain on AS, evaluate FT candidacy, and identify those needing whole-gland management.

Patient-reported functional outcomes and oncological control after primary focal cryotherapy for clinically significant prostate cancer: A Phase II mandatory biopsy-monitored study.

INTRODUCTION: We report herein the impact of focal therapy (FT) on multi-domain functional outcomes in a Phase II prospective clinical trial (NCT04138914) in focal cryotherapy for clinically significant prostate cancer (csPCa). METHODS: The primary outcome was the detection of a ≥5 point deterioration in any of the four main expanded prostate index composite (EPIC) functional domains. Pretreatment multiparametric magnetic resonance imaging (mpMRI) and transperineal targeted and systematic saturation biopsy were used to select patients with prostate-specific antigen (PSA)≤20 ng/mL, Gleason grade group (GG) ≤4, mpMRI lesion volume ≤ 3 mL (for a single lesion) or ≤1.5 mL (where two lesions were present). Focal cryotherapy was performed with a minimum 5 mm margin around each target lesion. EPIC scores were obtained at baseline and posttreatment at 1, 3, 6, and 12 months. Mandatory repeat mpMRI and prostate biopsy were performed at 12 months to determine the infield and outfield recurrence. RESULTS: Twenty-eight patients were recruited. The mean age was 68 years, with PSA of 7.3 ng/mL and PSA density of 0.19 ng/mL2 . No Clavien-Dindo ≥3 complications occurred. Transient worsening of EPIC urinary (mean diff 16.0, p < 0.001, 95% confidence interval [CI]: 8.8-23.6) and sexual function scores (mean diff 11.0, p:0.005, 95% CI: 4.0-17.7) were observed at 1-month posttreatment, with recovery by Month 3. A subgroup who had ablation extending to the neurovascular bundle had a trend to delayed recovery of sexual function to Month 6. At 12-month repeat mpMRI and biopsy, 22 patients (78.6%) had no detectable csPCa. Of the six patients (21.4%) who had csPCa recurrences, four were GG2, one GG3, and one GG4. Four patients underwent repeat FT, one underwent radical prostatectomy, while the remaining one patient with low-volume GG2 cancer opted for active surveillance. CONCLUSION: FT using cryotherapy was associated with a transient deterioration of urinary and sexual function with resolution at 3 months posttreatment and with reasonable early efficacy in well-selected csPCa patients.

Oncological and Functional Outcomes for Men Undergoing Salvage Whole-gland Cryoablation for Radiation-resistant Prostate Cancer.

BACKGROUND: There is no consensus on the optimal approach for salvage local therapy in radiation-resistant/recurrent prostate cancer (RRPC). OBJECTIVE: To investigate oncological and functional outcomes for men treated with salvage whole-gland cryoablation (SWGC) of the prostate for RRPC. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively reviewed our prospectively collected cryosurgery database between January 2002 and September 2019 for men who were treated with SWGC of the prostate at a tertiary referral center. INTERVENTION: SWGC of the prostate. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was biochemical recurrence-free survival (BRFS) according to the Phoenix criterion. Secondary outcomes included metastasis-free survival, cancer-specific survival, and adverse events. RESULTS AND LIMITATIONS: A total of 110 men with biopsy-proven RRPC were included in the study. Median follow-up for patients without biochemical recurrence (BCR) after SWGC was 71 mo (interquartile range [IQR] 42.3-116). BRFS was 81% at 2 yr and 71% at 5 yr. A higher prostate-specific antigen (PSA) nadir after SWGC was associated with worse BRFS. The median International Index of Erectile Function-5 score was 5 (IQR 1-15.5) before SWGC and 1 (IQR 1-4) after SWGC. Stress urinary incontinence, strictly defined as the use of any pads after treatment, was 5% at 3 mo and 9% at 12 mo. Clavien-Dindo grade ≥3 adverse events occurred in three patients (2.7%). CONCLUSIONS: In patients with localized RPPC, SWGC achieved excellent oncological outcomes with a low rate of urinary incontinence, and represents an alternative to salvage radical prostatectomy. Patients with fewer positive cores and lower PSA tended to have better oncological outcomes following SWGC. PATIENT SUMMARY: For men with prostate cancer that persists after radiotherapy, a freezing treatment applied to the whole prostate gland can achieve excellent cancer control. Patients who did not have elevated prostate-specific antigen (PSA) at 6 years after this treatment appeared to be cured.

Real-World Comparative Safety and Effectiveness of Irreversible Electroporation and High-Intensity Focused Ultrasound for Prostate Cancer Ablation.

OBJECTIVES: To assess the comparative safety and effectiveness of 2 prostate cancer treatment ablation modalities: irreversible electroporation (IRE) and high-intensity focused ultrasound (HIFU).  METHODS: Two systematic literature reviews (SLRs) and meta-analyses (MAs) on IRE and HIFU were conducted in accordance with PRISMA guidelines. Searches were conducted in PubMed and EMBASE. Independent reviewers assessed literature eligibility and abstracted safety and effectiveness data. Oncological, safety, functional, and quality of life (QOL) outcomes were examined for each technology. MAs were conducted where data quality and availability allowed, using normal methods and a random/mixed effects model, and quality assessments performed. RESULTS: Fifty-five publications (n = 22 IRE; n = 33 HIFU) were included in the SLRs, and MAs were conducted on negative in-field post-procedure biopsy, prostate-specific antigen (PSA) level reduction, potency, urinary continence, and AE rate outcomes. MAs revealed that IRE patients had lower mean percent PSA level reductions, higher mean rates of in-field negative post-treatment biopsy, and higher rates of potency maintenance than HIFU patients. Most adverse events (AEs) reported were comparable and minor (Grades I, II), with urinary tract infection, dysuria, hematuria, and incontinence or urgency most frequently reported. The proportion of patients experiencing a severe AE (≥Grade III) ranged from 0 to 8% after IRE and HIFU. Both modalities were associated with positive functional outcomes as well as maintenance of QOL after treatment. CONCLUSIONS: Both IRE and HIFU were found to produce favorable effectiveness outcomes and have low complication rates while minimally impacting patient urinary and erectile function and maintaining overall QOL. These real-world findings can help guide clinical decision making and improve disease management for patients with prostate cancer.