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Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC

A Prospective Randomized Controlled Study Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the Treatment of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

NCT05983783•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.

Detailed Description

To investigate the value of chemotherapy in the treatment of high-burden of mHSPC on the background of next-genertion of AR inhibitors.

Eligibility

Age

40 - 80 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Males aged ≥40 years and ≤80 years.
•2. Histologically or cytologically confirmed prostate adenocarcinoma.
•3. Metastatic disease.
•4. Eligible for ADT and Docetaxel.
•5. Started or not started first-generation androgen deprivation therapy (ADT), but not exceeding 12 weeks before randomization.
•6. ECOG score of 0 or 1.
•7. Laboratory tests meet the following requirements:
•* Hematology: neutrophils ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥9g/dL.
•* Renal function: serum creatinine ≤1.5× upper limit of normal (ULN).
•* Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN, total bilirubin (TBIL) ≤1.5× ULN.
+4 more criteria

Exclusion Criteria

•1. Prior use of LHRH agonists/antagonists; second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), or other investigational AR inhibitors; CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.
•2. Received radiation therapy/radiopharmaceutical treatment within 2 weeks before randomization.
•3. Any of the following conditions within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV).
•4. Previous malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or superficial bladder cancer not invading the deeper muscle layer (i.e., pTis, pTa, and pT1) and any other cancer in complete remission for at least 5 years before randomization.
•5. Gastrointestinal diseases or procedures that are expected to significantly interfere with the absorption of study treatment.
•6. Inability to take oral medication.

Locations (1)

Urology dpt, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Key Dates

Start Date

August 1, 2023

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2027

Last Updated

August 9, 2023

Enrollment

200

ESTIMATED participants

Conditions

Metastatic Prostate CancerHormone Sensitive Prostate CancerChemotherapy Effect

Interventions

Docetaxel

DRUG

Rezvilutamide

DRUG

Contacts

Shangqian Wang, M.D., Ph.D.

CONTACT

+862568303186 wsq5501@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: August 9, 2023Data 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.

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Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC

Inclusion Criteria

Exclusion Criteria

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