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

NCT07591467 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Experimental

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.

Sponsors & Collaborators

  • PHRC, Ministry of Health France

    collaborator UNKNOWN

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2036-09-30
Completion
2036-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07591467 on ClinicalTrials.gov