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

NCT ID: NCT05983783

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Metastatic Prostate Cancer; Hormone Sensitive Prostate Cancer; Chemotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

This is Triple drug regimen for mHSPC

Rezvilutamide+ADT

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

Group Type: ACTIVE_COMPARATOR

Rezvilutamide

Intervention Type: DRUG

This is doubling drug regimen for mHSPC

Interventions

Docetaxel

This is Triple drug regimen for mHSPC

Intervention Type: DRUG

Rezvilutamide

This is doubling drug regimen for mHSPC

Intervention Type: DRUG

Other Intervention Names

Rezvilutamide; ADT

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hua Lixin

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lixxin Hua

Role: PRINCIPAL_INVESTIGATOR

Urology Dpt, First Affiliated Hospital of Nanjing Medical University

Locations

Urology dpt, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

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

Role: CONTACT

wsq5501@126.com

+862568303186

Facility Contacts

Shangqian Wang, M.D.,PhD.

Role: primary

wsq5501@126.com

68303186

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

2023-SR-376

Identifier Type: -

Identifier Source: org_study_id