RecruitingPhase 2NCT06305832

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


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

102 participants

Start Date

Sep 7, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: MALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding the hormone-blocking drug rezvilutamide to standard salvage radiation therapy and androgen deprivation therapy (ADT) improves outcomes for men with prostate cancer that has returned after surgery, based on a rising PSA level. **You may be eligible if...** - You are male, aged 40 or older - Your prostate cancer returned after surgery (shown by a rising PSA above 0.2 ng/mL on two consecutive tests at least 2 weeks apart) - Imaging scans (bone scan and CT/MRI) do not show visible local or distant spread - Your PSA dropped below 0.1 ng/mL for at least 6 months after surgery - You have one or more high-risk features such as a high post-surgery risk score, high Gleason grade (8–10), PSA peak above 0.5 ng/mL, or advanced tumor stage (pT3/T4) **You may NOT be eligible if...** - There is visible evidence of cancer spread on standard imaging - Your PSA did not drop appropriately after surgery - You have serious heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRezvilutamide

Specifications of 80 mg; orally, once a day

DRUGAndrogen 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

RADIATIONSRT

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)


Locations(2)

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Nanjing, Jiangsu, China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

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NCT06305832


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