Carboplatin-Enhanced Therapy in BRCA-Mutated or Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT07591467
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • BRCA-Mutated
  • Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer
  • Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Experimental — DRUG
    Lifelong continuous ADT and darolutamide, similarly to standard of care, with the addition of docetaxel (60mg/m² per cycle) and carboplatin, with an area under the curve (AUC) of 4 mg/mL/min (AUC 4), 6 cycles + G-CSF support. For eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy.

Study Details

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.

Key Dates

First listed
May 15, 2026
Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2036
Completion
Dec 31, 2036

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm
    Lifelong continuous ADT and darolutamide, similarly to standard of care, with the addition of docetaxel (60mg/m² per cycle) and carboplatin, with an area under the curve (AUC) of 4 mg/mL/min (AUC 4), 6 cycles + G-CSF support. For eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy.
  • No Intervention: Control arm: Standard of care (SoC)
    Standard of care therapies consisting of lifelong ADT and continuous darolutamide, docetaxel (75 mg/m² per cycle, 6 cycles + G-CSF support) and for eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy.

Primary Outcome Measure

Radiographic progression-free survival [ Time Frame: from randomization to radiographic progression or death, maximum 10 years ]

Central Contacts

Find similar trials

Nationwide
Prostate cancer trialsOncology trialsProstate oncology trialsMen's health trialsUrology trials

Related Studies