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

August 2, 2023 updated by: Hua Lixin, The First Affiliated Hospital with Nanjing Medical University

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shangqian Wang, M.D., Ph.D.
  • Phone Number: +862568303186
  • Email: wsq5501@126.com

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Urology dpt, First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Principal Investigator:
          • Lixin Hua, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
    • Coagulation function: international normalized ratio (INR) <1.5.
  8. Study subjects: Patients with mHSPC have a confirmed pathology of prostate adenocarcinoma with high tumor burden, which is defined by having at least one of the following conditions:

1) Bone scan showing ≥4 bone metastatic lesions (with at least one site outside the pelvis or spine).

2) CT/MRI revealing visceral metastatic lesions (excluding lymph nodes).

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible to participate in this study:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rezvilutamide+ADT+Docetaxel

Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food.

Docetaxel 6 cycles
Drug: Docetaxel
This is Triple drug regimen for mHSPC
Other Names:
  • Rezvilutamide
Active Comparator: Rezvilutamide+ADT
Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food.
Drug: Rezvilutamide
This is doubling drug regimen for mHSPC
Other Names:
  • ADT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rPFS
Time Frame: 36 months
radiographic Progression-Free Survival
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prostate-specific antigen (PSA) response rate
Time Frame: 36 months
percentage of patients with a decreasing PSA following the regimens discussed above
36 months
time to castration-resistant prostate cancer (CRPC)
Time Frame: 36 months
time to PSA progression
36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to next bone-related event
Time Frame: 36 months
Including bone structure, pain, etc.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Lixxin Hua, Urology dpt, First Affiliated Hospital of Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-SR-376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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