Adjuvant Rezvilutamide Monotherapy for High-Risk Prostate Cancer After Radical Prostatectomy
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Prostate cancer patients with high-risk features who undergo radical prostatectomy (RP) are at a significant risk of biochemical recurrence (BCR) and disease progression. While adjuvant androgen deprivation therapy (ADT) with or without radiotherapy is the current standard of care, long-term ADT is associated with substantial adverse effects, including metabolic syndrome, cardiovascular disease, and bone density loss, which negatively impact patients' quality of life. There is an unmet clinical need to optimize adjuvant treatment strategies to improve survival outcomes while minimizing treatment-related toxicity for this high-risk population. Rezvilutamide is a novel, potent, second-generation oral androgen receptor (AR) inhibitor. This prospective, multicenter, single-arm clinical trial aims to evaluate the efficacy and safety of rezvilutamide monotherapy as an adjuvant treatment in patients with localized prostate cancer who have a high risk of recurrence following radical prostatectomy. The study plans to enroll 48 male patients (aged 18-75 years) who have completed radical prostatectomy within 12 weeks, have achieved a postoperative prostate-specific antigen (PSA) level of \< 0.1 ng/mL within 8 weeks, and possess a high recurrence risk defined by a CAPRA-S score of ≥ 6. Eligible patients will receive rezvilutamide monotherapy at a dose of 240 mg orally once daily for 12 cycles (28 days per cycle, totaling 48 weeks). The primary endpoint of the study is the 2-year biochemical progression-free survival (bPFS) rate. Secondary endpoints include event-free survival rate, 5-year bPFS, 5-year metastasis-free survival (MFS), testosterone recovery rate and time at 2 years, overall safety, and health-related quality of life assessed by the FACT-P and EPIC-26 questionnaires. By exploring this monotherapy approach, the study hopes to provide a new, effective, and better-tolerated adjuvant treatment option that can improve the prognosis of high-risk patients post-prostatectomy.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyźni w wieku 18-75 lat z potwierdzonym rakiem prostaty
- •Poddani operacyjnemu usunięciu gruczołu prostaty w ciągu ostatnich 12 tygodni
- •Niezwykle niski poziom markera PSA (poniżej 0,1) w ciągu 8 tygodni po zabiegu
- •Wysoki риск powrotu choroby (wynik CAPRA-S co najmniej 6 punktów)
- •Dobry stan ogólny organizmu (skala ECOG 0-1)
- •Prawidłowe wyniki badań krwi i funkcji nerek/wątroby
- •Niemożliwość lub niechęć do radioterapi
- •Zdolność do podpisania świadomej zgody i uczestnictwa w badaniu
✗ Disqualifies
- •Specyficzne typy raka prostaty (neuroendokrynne, małokomórkowe lub mięssakowe)
- •Przerzuty do węzłów chłonnych lub narządów odległych potwierdzone przed operacją
- •Poprzednie leczenie hormonalne (chemiczna lub chirurgiczna kastracja)
- •Brak zdolności do przyjmowania leków drogą ustną
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- July 23, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Nanjing Drum Tower Hospital, Affilitated Hospital of Medical School, Nanjing University
Nanjing, China
Trial contact
Xuefeng Qiu, Doctor
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/18/2026.
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