Comparing two treatments for metastatic hormone-sensitive prostate cancer

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)

This study is testing if adding chemotherapy to a hormone treatment can help men with advanced prostate cancer live longer compared to just using hormone treatment alone.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 40 Years to 80 Years
• Sex: Male
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05983783 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of combining Rezvilutamide with androgen deprivation therapy (ADT) and docetaxel against Rezvilutamide and ADT alone in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study aims to determine if the addition of chemotherapy improves overall survival in this patient population. Participants will be males aged 40 to 80 years with confirmed prostate adenocarcinoma and high tumor burden, who are eligible for ADT and docetaxel. The trial will assess various laboratory parameters to ensure participant safety and eligibility.

Who should consider this trial

Good fit: Ideal candidates are males aged 40 to 80 with confirmed metastatic prostate adenocarcinoma and high tumor burden.

Not a fit: Patients with non-metastatic prostate cancer or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates for patients with metastatic hormone-sensitive prostate cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of androgen deprivation therapy and chemotherapy in prostate cancer treatment.

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.

Where this trial is running

Nanjing, Jiangsu

• Urology dpt, First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Lixxin Hua — Urology Dpt, First Affiliated Hospital of Nanjing Medical University
• Study coordinator: Shangqian Wang, M.D., Ph.D.

Conditions Metastatic Prostate Cancer; Hormone Sensitive Prostate Cancer; Chemotherapy Effect; Rezvilutamide; mHPSC; chemotherapy; Androgen deprivation therapy