NCT05983783 Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC
| NCT ID | NCT05983783 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Metastatic Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2023-08-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Lixxin Hua
PRINCIPAL INVESTIGATOR
Urology Dpt, First Affiliated Hospital of Nanjing Medical University
Frequently Asked Questions
Who can join the NCT05983783 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 80 Years, studying Metastatic Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05983783 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT05983783 currently recruiting?
Yes, NCT05983783 is actively recruiting participants. Contact the research team at wsq5501@126.com for enrollment information.
Where is the NCT05983783 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT05983783 clinical trial?
NCT05983783 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Lixxin Hua at Urology Dpt, First Affiliated Hospital of Nanjing Medical University. The trial plans to enroll 200 participants.
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