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

RECRUITINGPHASE2

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

NCT06305832•The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

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

Age

40 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•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
•5\. Biochemical recurrence (PSA rose twice in a row, with an interval of ≥2 weeks and absolute value \> 0.2ng/ml), and traditional imaging (bone scan and CT/MRI scan) did not show local recurrence and distant metastasis.
•6\. Have one or more of the following risk factors:
•* Postoperative CAPRA-S score ≥6 points;
•* The pathological score of radical surgery for prostate cancer was Gleason 8-10;
•* The highest postoperative biochemical recurrence PSA \> 0.5ng/ml;
•* Postoperative pathological stage PT3/T4;
+13 more criteria

Exclusion Criteria

•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;
•5\. Known or suspected allergy to reverumide and reverumide excipients;
•6\. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect drug use and absorption;
•7\. Have a history of epilepsy, or a medical condition that can induce seizures within the 12 months prior to C1D1 (including a history of transient ischemic attacks, cerebral stroke, traumatic brain injury with disturbance of consciousness requiring hospitalization);
•8\. Active heart disease in the 6 months prior to C1D1, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and medically treatable ventricular arrhythmias;
•9\. Have had any other malignancies within the 3 years prior to C1D1 (except for carcinoma in situ that has been in complete remission and malignancies that the investigator determined to be slowly progressing);
•10\. Granulocyte colony-stimulating factor was used for support 2 weeks before C1D1;
+5 more criteria

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

Key Dates

Start Date

September 7, 2023

Primary Completion Date

March 1, 2028

Completion Date

March 1, 2028

Last Updated

March 12, 2024

Enrollment

102

ESTIMATED participants

Conditions

Prostate CancerBiochemical Recurrence

Interventions

Rezvilutamide

DRUG

Androgen deprivation therapy (ADT)

DRUG

SRT

RADIATION

Contacts

Hongqian Guo, phD

CONTACT

13605171690 dr.ghq@nju.edu.cn

Shun Zhang, MD

CONTACT

15050589789 explorershun@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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