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

Chemotherapy Effect Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05983783
• Other study ID #: 2023-SR-376
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: August 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Shangqian Wang, M.D., Ph.D.
• Phone: +862568303186
• Email: wsq5501[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy Effect
• Hormone Sensitive Prostate Cancer
• Hypersensitivity
• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel
This is Triple drug regimen for mHSPC
• Rezvilutamide
This is doubling drug regimen for mHSPC

Locations

Country	Name	City	State
China	Urology dpt, First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time to next bone-related event	Including bone structure, pain, etc.	36 months
Primary	rPFS	radiographic Progression-Free Survival	36 months
Secondary	prostate-specific antigen (PSA) response rate	percentage of patients with a decreasing PSA following the regimens discussed above	36 months
Secondary	time to castration-resistant prostate cancer (CRPC)	time to PSA progression	36 months