RecruitingPhase 2NCT05753566

Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer

Efficacy and Safety of Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: A Prospective, Multi-centre Study


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

96 participants

Start Date

Mar 1, 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 rezvilutamide in 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 is testing whether rezvilutamide, a hormone-blocking medication, can delay or prevent prostate cancer from coming back in men whose PSA levels are rising after prostate removal surgery — a situation called biochemical recurrence. **You may be eligible if...** - You are a male, 40 or older - You have a confirmed diagnosis of prostate adenocarcinoma - Your PSA level was below 0.1 ng/mL for at least 6 months after your prostatectomy - Your PSA has now risen above 0.2 ng/mL on two separate tests taken at least 2 weeks apart - There is no visible sign of cancer returning locally or spreading elsewhere - Your lymph nodes were negative (or unable to be assessed) at surgery **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - Your PSA did not drop low enough after surgery - You have already received hormonal or radiation therapy for recurrence 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)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

JiangSu Cancer Hospital

Nanjing, Jiangsu, China

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NCT05753566


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