The purpose of this clinical phase 3 randomized trial is to compare two different dosing schedules of Docetaxel in combination with ADT and Darolutamide in subjects with mHSPC. The main question aims to compare grade 3-5 adverse events (AEs) in patients with mHSPC treated with 6 cycles of either Docetaxel 75 mg/m2 every 3 weeks in a 3 week cycle or 6 cycles of Docetaxel 50 mg/m2 every 2 weeks in a 4 week cycle in combination with Darolutamide + ADT. The primary endpoint are Grade 3-5 AEs, followed by neutropenia grade 3/4 + grade 5 AEs to be analysed 28 weeks after last patient first Docetaxel dose (LPFD).
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent
* Males ≥18 years of age
* Histologically or cytologically confirmed adenocarcinoma of prostate
* Investigator assessed metastatic disease documented either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed. Metastatic disease is defined as either malignant lesions in bone scan or soft tissue/visceral lesions according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Lymph nodes are measurable if the short axis diameter is ≥15 mm, soft tissue/visceral lesions are measurable if the long axis diameter is ≥10 mm.
* Subjects with lymph node metastases only (either below the aortic bifurcation (N1) or above the aortic bifurcation (M1a)) will not be eligible for the study.
* Subjects must be candidates for ADT, docetaxel and darolutamide therapy per Investigator's judgment
* Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but no longer than 12 weeks before randomization. For subjects receiving LHRH agonists, treatment in combination with a first generation anti-androgen for at least 4 weeks, prior to randomization is recommended. First generation anti-androgen has to be stopped prior to randomization.
* An Eastern Cooperative Oncology Group performance status of 0 or 1
* Blood counts at Screening: hemoglobin ≥9.0 g/dL, absolute …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this Phase 3 trial is comparing two different dosing schedules of docetaxel — one given every 3 weeks at 75 mg/m2 versus one given every 2 weeks at 50 mg/m2 — can you help me understand which schedule might be safer or more manageable based on what's been seen so far?
2The trial's main thing being measured is the rate of serious side effects (Grade 3-5 adverse events), which tells me safety is still being figured out — does that change how you'd weigh this against a standard treatment approach for my situation?
3Since the trial is no longer actively enrolling new patients, does that mean I'm unlikely to be able to join, or are there still ways to explore participation?
4Both schedules combine docetaxel with darolutamide and ADT — how does adding darolutamide to chemotherapy compare to what I'd receive outside a trial, and is that combination already considered standard of care for my stage?
5Given the intensity of receiving both chemotherapy and hormone therapy together on either schedule, what does my current health status suggest about how well I might tolerate either dosing approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of grade 3-5 AEs
Timeframe: 28 weeks after last patient first Docetaxel dose (LPFD)