Carboplatin-Enhanced Therapy in BRCA-Mutated or Neuroendocrine-Differentiated Aggressive Metastat… (NCT07591467) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Carboplatin-Enhanced Therapy in BRCA-Mutated or Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer
France330 participantsStarted 2026-09
Plain-language summary
The current standard of patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) is to offer androgen deprivation therapy (ADT) with androgen receptor pathway inhibitors (ARPI). In addition, upfront 6 cycles of docetaxel, if patient is eligible, and prostate radiotherapy for those with low-volume disease are recommended. BRCA mutations (BRCAm) and neuroendocrine differentiation (NED) confer a poor prognosis in mHSPC and the current standard of care for these patients remains suboptimal. While PARP inhibitors have shown efficacy in BRCAm castration-resistant prostate cancer, concerns exist about their toxicity and resistance when used earlier in the mHSPC setting. Carboplatin has demonstrated activity in BRCAm and neuroendocrine tumors but has not been extensively studied in mHSPC. The combination of carboplatin and docetaxel is expected to enhance treatment efficacy and delay progression.
Who can participate
Age range
18 Years – 80 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
. Histologically or cytologically proven adenocarcinoma of the prostate (any T stage, Gleason score or PSA level).
. De novo metastatic disease documented by a positive bone scan or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either: at least one extra-pelvic lymph node ≥ 2 cm, or extra-pelvic lymph node(s)≥1 cm if the patients also have at least one pelvic lymph node ≥ 1.5 cm.
. Presence of pathogenic BRCA gene alteration (BRCAm cohort) OR histologically adenocarcinoma of the prostate with neuroendocrine differentiation (NED cohort)
. For the BRCAm cohort: confirmation of a pathogenic BRCA gene alteration by historical analysis, using one of the following:
. For the NED cohort: histologically adenocarcinoma of the prostate with neuroendocrine differentiation41. NED is defined as either:
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Radiographic progression-free survival
Timeframe: from randomization to radiographic progression or death, maximum 10 years
. Patients with ECOG PS ≤ 1, or patient with PS 2, provided PS alteration is disease-related.
. Life expectancy of at least 6 months.
. Male aged ≥ 18 years old and ≤ 80 years old.
Exclusion criteria
. Patients with previous definitive local treatment directed to prostate primary cancer (radiotherapy, brachytherapy, radical prostatectomy, ultrasound, cryotherapy, or other). A previous trans-urethral resection of the prostate (TURP) and previous local treatments of metastases are allowed.
. Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer. Prior exposure to carboplatin or other platinum containing compounds.
. Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropath\\\>= grade 2, per the Common Terminology Criteria for Adverse Events version 6.0.
. Patients known to be human immunodeficiency virus (HIV) positive, symptomatic viral hepatitis or chronic liver disease.
. Patient with administration of live or live attenuated vaccines (strongly discouraged in patients) and is formally contraindicated in the case of the yellow fever vaccine.
. Severe or moderate hepatic impairment (Child - Pugh class C or B).
. Clinically known significant heart disease in the past 6 months as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \< 50% at baseline, atrial fibrillation, or other cardiac arrhythmia requiring therapy.
. History of malignancy, except non-melanoma skin cancer, with low risk of recurrence within 24 months.