Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age40+
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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 SRT combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).

Eligibility criteria

Qualifiers

1. ≥40 years old, male;

2. Postoperative pathology showed prostate adenocarcinoma;

3. Postoperative pathological stage pN0 or pNx;

4. PSA decline < 0.1ng/ml within 8 weeks after radical prostate cancer surgery for at least 6 months

Disqualifiers

1. Previously received endocrine therapy for prostate cancer (including but not limited to goserrelin, levoprorelin, digarek, bicalutamide, abiraterone acetate, darotamine, apatamide, enzalutamide, etc.) or pelvic radiotherapy;

2. Postoperative biochemical recurrence, but PSA more than 2 ng/ml;

3. Postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features;

4. Is currently participating in or has participated in an investigational drug study;

Trial design

Treatments tested in this trial

  • Rezvilutamide
  • Androgen deprivation therapy (ADT)
  • SRT

Treatment groups

102 Participants
are divided into 2 treatment groups