Nutritional Supplement With Fermented Soy in Men With an Elevated Risk of Prostate Cancer and Negative Prostate Biopsies: General and Oncological Results From the Prospective PRAECAP Trial.

OBJECTIVE: To investigate the effect of a dietary supplement containing fermented soy on PSA, IPSS, changes in prostate volume and prostate cancer (PCa) development after a 6-month challenge in men at increased risk of PCa and negative previous biopsies. MATERIALS AND METHODS: Patients with an elevated risk of PCa, defined by either 1 of the following criteria: PSA >3 ng/mL, suspect lesion at digital rectal examination (DRE), suspect lesion at transrectal ultrasound (TRUS)/magnetic resonance imaging (MRI) and previous negative prostate biopsies (at least 8 cores) within 12 months before inclusion. Statistical analysis was carried out using a non-parametric 1-sided paired Wilcoxon rank sum test, chi-square test, and Fisher's exact test. RESULTS: In this trial, 94 patients were eligible for analysis. A PSA response was detected in 81% of the cases. In 25.8% (24/93) of patients, a decrease of at least 3 points on the IPSS was observed. The median prostate volume did not statistically change after 6 months (P = .908). Patients with PSA modulation required fewer investigations and had fewer positive biopsies (P <.001) and significantly fewer ISUP ≥3 lesions (P = .02). CONCLUSION: We observed a significantly lower PSA level after a 6-month challenge with a fermented soy-containing supplement, and an effect on IPSS in a subset of patients. Prescribing a fermented soy supplement in patients with an increased PCa risk could lead to a better selection of patients at real increased risk of having occult PCa.

Defining the optimal template of salvage lymph node dissection for unilateral pelvic nodal recurrence of prostate cancer following radical prostatectomy.

OBJECTIVES: Several retrospective studies have shown that salvage bilateral pelvic lymph node dissection (sLND) is a valid treatment option in the setting of oligorecurrent nodal prostate cancer following radical prostatectomy. Little is known about the optimal template of such sLND in patients with strictly unilateral pelvic recurrence on PET-CT imaging. In this study, we investigated whether a unilateral pelvic sLND could be sufficient in such a setting. METHODS: We retrospectively collected data of patients treated with sLND between 2010 and 2019 at the University Hospitals, Leuven. Patients were included if they developed recurrence following radical prostatectomy, characterized by ≤3 unilateral pelvic lymph node metastases on Choline or PSMA PET-CT and received a super-extended bilateral pelvic sLND as first metastasis-directed therapy. As a primary endpoint, we investigated in how many cases a unilateral sLND would have been sufficient. RESULTS: In total, 44 patients with strictly unilateral pelvic recurrence were treated with super-extended bilateral pelvic sLND. In 5 out of 44 (11%) patients, histological examination showed presence of prostate cancer in the contralateral hemi-pelvis. In the group with a single positive node on imaging prior to sLND, only 1 out of 27 (3%) patients had contralateral disease at final pathology. No one (0%) in this group subsequently developed recurrence in the contralateral hemi-pelvis following sLND. CONCLUSIONS: In conclusion, this study suggests that unilateral pelvic sLND could be sufficient in patients with a single unilateral pelvic lymph node recurrence on PET/CT imaging.

Neoadjuvant treatment with androgen receptor signaling inhibitors prior to radical prostatectomy: a systematic review.

CONTEXT: There is an urgent need to develop novel treatment strategies in patients with unfavorable intermediate- and high-risk localized prostate cancer (PCa) to optimize the outcome of these patients. Androgen receptor signaling inhibitors (ARSI) have demonstrated a survival benefit in metastatic hormonesensitive and castration-resistant PCa. A similar benefit might be expected in the localized setting. OBJECTIVE: To perform a systematic review about the role of neoadjuvant ARSI in unfavorable intermediate and high-risk localized PCa. EVIDENCE ACQUISITION: We performed a systematic review of the following databases: MEDLINE (PubMed), EMBASE, Cochrane Library and Web of Science. Publications of ASCO were consulted to identify meeting abstract with early results of ongoing trials. This systematic review was performed and reported in accordance with the PRISMA guidelines. EVIDENCE SYNTHESIS: Pathological complete response (pCR) following neoadjuvant ARSI treatment was observed in 4%-13% of the patients. Minimal residual disease response ranged from 36% to 73.9% when defined as residual cancer burden < 0.25 cm3 at final pathology and from 8% to 20% when defined as the diameter of the remaining tumor < 5 mm. Despite intense neoadjuvant ARSI treatment, residual pT3 disease was observed in 48%-76% of the patients. In contrast, positive surgical margins (PSM) were present in only 5%-22%. Only one trial reported BCR following neoadjuvant ARSI therapy (44% BCR at a median follow-up of 4 years). CONCLUSION: Despite intense neoadjuvant ARSI therapy, pCR is rarely attained and high proportions of pT3 disease are still observed at final pathology. In contrast, promising results are obtained in terms of PSMs. Long-term survival outcomes are eagerly awaited.