Abstract 778TiP
Background
Adjuvant therapy post-radical prostatectomy aims to address residual disease, suppress recurrence and improve survival. Standard care for adjuvant therapy of high-risk localized prostate cancer includes radiotherapy ± androgen-deprivation therapy (ADT). However, current ADT regimens are limited in efficacy, possibly from inadequate androgen receptor (AR) signaling suppression. There's a need for more effective AR-targeted therapies. Rezvilutamide is a novel AR inhibitor with minimal blood-brain barrier penetration, has shown good tolerance and safety in combination with ADT, and demonstrated robust antitumor efficacy in patients with metastatic prostate cancer. This study aims to preliminarily explore the efficacy and safety of rezvilutamide combined with ADT, with or without radiotherapy, in high-risk patients after radical prostatectomy.
Trial design
This multicenter, open-label, two-cohort study will recruit 96 patients from five top-tier hospitals in China. Eligible patients will have undergone radical prostatectomy within 3 months with no preoperative metastasis, and exhibit at least two postoperative high-risk factors: positive surgical margin, pT3-4, Gleason score 8-10 or ISUP grade 4-5, PSA ≥ 20 ng/ml. Cohort 1, for those declining or ineligible for radiotherapy, will receive 24 cycles of rezvilutamide (240 mg/day, 28 days per cycle) combined with ADT. Cohort 2 will receive 12 cycles of radiotherapy combined with rezvilutamide and ADT, enrolling 48 patients per cohort. Primary endpoint is the rate of 3-year biochemical progression-free survival (bPFS), defined by a PSA increase ＞ 0.2 ng/ml above the post-treatment nadir (confirmed by two consecutive measures at least 2 weeks apart), or participant death. Secondary endpoints include bPFS, 4-year metastasis-free survival (MFS) rate, time to testosterone recovery, and testosterone recovery rate, and exploratory endpoints include safety profiles, overall quality of life, and the exploration of the relationship between efficacy, safety, and biomarkers. Enrollment is ongoing.
Clinical trial identification
ChiCTR2400082670; Release date: April 03, 2024.
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.