NCT06305832

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

Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Prostate Cancer
• Biochemical Recurrence

Interventions

Type	Name	Description
DRUG	Rezvilutamide	Specifications of 80 mg; orally, once a day
DRUG	Androgen deprivation therapy (ADT)	Androgen deprivation therapy (ADT), the ADT used by each subject will be determined by the investigator,and the dose and frequency of administration will be consistent with the prescription information
RADIATION	SRT	SRT according to standard of care (66.6-72 grays will be delivered to the bed of prostate ,\~50.4 grays to the pelvis if needed)

Timeline

• Start date: 2023-09-07
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2024-03-12
• Last updated: 2024-03-12

Locations

2 sites across 1 country: China