About this trial
To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or rezvilutamide in combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).
Eligibility criteria
Qualifiers
Age ≥ 40 years, male.
Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
Patients with PSA < 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
Disqualifiers
Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
Postoperative biochemical recurrence with PSA > 2 ng/ml.
Postoperative pathology containing neuro-endocrine differentiation or small cell features.
Prior malignancy other than prostate cancer in the past three years.
Trial design
Treatments tested in this trial
- Rezvilutamide
- Androgen deprivation therapy (ADT)
- SRT
Treatment groups
Sponsors and collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator