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

NCT05753566 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-03-06

No results posted yet for this study

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).

Conditions

Interventions

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)

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Chief physician of Department of Urology · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2027-03-31
Completion
2028-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05753566 on ClinicalTrials.gov