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Compares treatment options for Metastatic Prostate Cancer
Official title Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC
ClinicalTrials.gov ID: NCT05983783
What this study is testing
What is Docetaxel?
Docetaxel is an investigational medicine, being studied as a potential treatment for metastatic prostate cancer.
Also referred to as Rezvilutamide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80, men only
You may be able to join 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.
You likely can't join 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...
- 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...
- Previous malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or superficial bladder cancer not invading...
- Gastrointestinal diseases or procedures that are expected to significantly interfere with the absorption of study treatment.
See the full eligibility criteria
- 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 people: 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...
- 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...
- 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...
- 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...
- Gastrointestinal diseases or procedures that are expected to significantly interfere with the absorption of study treatment.
- Inability to take oral medication.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.