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Compares treatment options for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Official title Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC
ClinicalTrials.gov ID: NCT05956639
What this study is testing
What is 6-month course of antiandrogen drugs?
6-month course of antiandrogen drugs is an investigational medicine, being studied as a potential treatment for metastatic hormone-sensitive prostate cancer (mhspc).
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
- Primary Objective: To explore whether a 6-month course of Rezvilutamide in the triple therapy regimen is non-inferior to long-term Rezvilutamide treatment in improving radiographic progression-free survival (rPFS) in patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC). Secondary Objectives: To evaluate and compare the time to prostate-specific antigen (PSA) progression, time to next bone-related event, time to initiation of subsequent anti-prostate cancer treatment, and objective response rate (ORR) between the 6-month and long-term course of Rezvilutamide with androgen deprivation therapy (ADT) plus docetaxel in patients with high tumor burden mHSPC.
- 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 18 and older, men only
You may be able to join if
- 1. Age ≥ 18 years, male.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine or small cell features.
- High tumor burden, defined as having at least one of the following conditions: 1) Bone scan showing ≥4 bone metastatic lesions (with at least one...
- Planned to receive or maintain androgen deprivation therapy (ADT) during the study period, either by continuous LHRHa treatment or previous bilateral...
You likely can't join if
- Prior treatment with ADT, chemotherapy, surgery, external beam radiation therapy, brachytherapy, radiopharmaceuticals, or investigational local...
- Up to 3 months of ADT (medical or surgical castration) with or without antiandrogen therapy prior to Cycle 1 Day 1 (C1D1) without evidence of...
- Transurethral prostatectomy or up to one course of palliative radiation therapy or surgery for symptomatic treatment of metastatic disease at least 4...
- Prior use or planned use of second-generation androgen receptor antagonists (such as enzalutamide, apalutamide, darolutamide), abiraterone acetate...
- Received the following treatments within 4 weeks before C1D1:
- 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride).
See the full eligibility criteria
Who can join
- 1. Age ≥ 18 years, male.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine or small cell features.
- High tumor burden, defined as 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...
- Planned to receive or maintain androgen deprivation therapy (ADT) during the study period, either by continuous LHRHa treatment or previous bilateral orchiectomy (surgical castration), concurrently with 6 cycles of...
- Organ function levels must meet the following requirements:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L.
- Platelets (PLT) ≥ 100 × 10\^9/L.
- Hemoglobin (Hb) ≥ 90 g/L.
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN).
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN.
- Blood urea nitrogen (BUN) (or urea) and creatinine (Cr) ≤ 1.5 × ULN.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- Judged by the investigator to be able to comply with the trial protocol.
- Voluntarily participate in the clinical trial, understand the study procedures, and have signed the informed consent form.
What rules you out
- Prior treatment with ADT, chemotherapy, surgery, external beam radiation therapy, brachytherapy, radiopharmaceuticals, or investigational local therapies for prostate pain. However, the following cases are allowed for...
- Up to 3 months of ADT (medical or surgical castration) with or without antiandrogen therapy prior to Cycle 1 Day 1 (C1D1) without evidence of radiographic disease progression (based on RECIST 1.1 criteria) or clinically...
- Transurethral prostatectomy or up to one course of palliative radiation therapy or surgery for symptomatic treatment of metastatic disease at least 4 weeks prior to C1D1. All adverse events related to these treatments...
- Prior use or planned use of second-generation androgen receptor antagonists (such as enzalutamide, apalutamide, darolutamide), abiraterone acetate, or other investigational drugs inhibiting testosterone synthesis for...
- Received the following treatments within 4 weeks before C1D1:
- 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride).
- Estrogens, progestins, androgens, systemic corticosteroids (except for temporary use for allergic purposes).
- Known herbal medicines with anti-prostate cancer or PSA-lowering effects (e.g., saw palmetto).
- Participation in other clinical trials involving investigational treatments.
- Confirmed brain tumor lesions on imaging.
- Planned to receive any other anticancer treatment during the trial.
- Known allergy or hypersensitivity to apalutamide, ADT, or chemotherapy components.
- Presence of conditions that impede swallowing, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.
- History of seizures or occurrence of conditions that can induce seizures within 12 months before C1D1 (including transient ischemic attack, stroke, traumatic brain injury with altered consciousness requiring...
- Presence of active cardiac diseases within 6 months before C1D1, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medication.
- Diagnosis of any other malignancy within 5 years before C1D1, except for completely resolved in situ cancer or malignancies with slow progression as determined by the investigator.
- Active HBV or HCV infection (HBV viral load ≥ 10,000 copies/mL, HCV viral load ≥ 1,000 copies/mL).
- History of immunodeficiency (including positive HIV test) or organ transplantation.
- Unwillingness to use effective contraception during the entire study treatment period and for 30 days after the last dose.
- Judged by the investigator to have conditions that pose a serious risk to patient safety, may confound study results, or may affect the patient's ability to complete the study (such as poorly controlled hypertension...
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, 18 years and older. 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.