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

NCT05983783 | Recruiting Phase 3

• 1 other identifier: 2023-SR-376
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Prostate Cancer; Hormone Sensitive Prostate Cancer; Chemotherapy Effect

Keywords

Rezvilutamide; mHPSC; chemotherapy; Androgen deprivation therapy

Outcome Measures

Primary Outcomes (1)

• rPFS

  radiographic Progression-Free Survival

  36 months

Secondary Outcomes (2)

• prostate-specific antigen (PSA) response rate

  36 months

• time to castration-resistant prostate cancer (CRPC)

  36 months

Other Outcomes (1)

• time to next bone-related event

  36 months

Study Arms (2)

Rezvilutamide+ADT+Docetaxel

EXPERIMENTAL

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

Rezvilutamide+ADT

ACTIVE COMPARATOR

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

Drug: Rezvilutamide

Interventions

Docetaxel DRUG

This is Triple drug regimen for mHSPC

Also known as: Rezvilutamide

Rezvilutamide+ADT+Docetaxel

Rezvilutamide DRUG

This is doubling drug regimen for mHSPC

Also known as: ADT

Rezvilutamide+ADT

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged ≥40 years and ≤80 years.
• Histologically or cytologically confirmed prostate adenocarcinoma.
• Metastatic disease.
• Eligible for ADT and Docetaxel.
• Started or not started first-generation androgen deprivation therapy (ADT), but not exceeding 12 weeks before randomization.
• ECOG score of 0 or 1.
• 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.
• 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:
• \) Bone scan showing ≥4 bone metastatic lesions (with at least one site outside the pelvis or spine).
• \) CT/MRI revealing visceral metastatic lesions (excluding lymph nodes).

You may not qualify if:

• Patients who meet any of the following criteria are not eligible to participate in this study:
• 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.
• Received radiation therapy/radiopharmaceutical treatment within 2 weeks before randomization.
• 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).
• 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.
• Gastrointestinal diseases or procedures that are expected to significantly interfere with the absorption of study treatment.
• Inability to take oral medication.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Urology dpt, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Lixxin Hua

  Urology Dpt, First Affiliated Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+862568303186; wsq5501@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: August 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)