Clinical trial NCT05983783: Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metastatic Prostate Cancer
Hormone Sensitive Prostate Cancer
Chemotherapy Effect
Keywords: Rezvilutamide
mHPSC
chemotherapy
Androgen deprivation therapy
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 200
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: rPFS
timeFrame: 36 months
Secondary outcomes:
measure: prostate-specific antigen (PSA) response rate
timeFrame: 36 months
measure: time to castration-resistant prostate cancer (CRPC)
timeFrame: 36 months
Other outcomes:
measure: time to next bone-related event
timeFrame: 36 months
Locations:
city: Nanjing
country: China
facility: Urology dpt, First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Urology Dpt, First Affiliated Hospital of Nanjing Medical University
name: Lixxin Hua
role: PRINCIPAL_INVESTIGATOR
References: