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Completed

NCT Number: NCT03652493

Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway

The investigators propose a phase II study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the Homologous Recombination (HR) pathway.

This study may also better characterize the molecular abnormalities of tumors required for the carboplatin response

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Centre François Baclesse, Caen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 18 years old
  • Patients with adenocarcinoma or poorly differentiated prostate carcinoma, histologically confirmed (small-cell histology or high-grade neuroendocrine histology excluded)
  • Tumor presenting a somatic pathogenic variant likely to alter the homologous recombination pathway previously detected on a tumor biopsy or on circulating tumor DNA, or germinal mutation among the list of genes defined in the study
  • Castration-resistant tumor defined by progression despite well-conducted androgen deprivation treatment: testosterone ≤50ng /dL agonist / antagonist of luteinizing hormone-releasing hormone (LHRH) or surgical castration. The patient must agree to continue concomitant LHRH-mediated (agonist or antagonist) therapy throughout the duration of the study regimen for patients with no history of surgical castration.
  • Patients must have performed at least one line of chemotherapy by taxane in case of castration resistance:
  • Patients who have received docetaxel treatment in a hormone-sensitive situation must have received at least treatment with cabazitaxel in case of castration resistance
  • Patients who have not received chemotherapy in a hormone-sensitive situation must have received docetaxel AND cabazitaxel or have a contraindication to discontinue treatment.
  • Patients must have been treated with at least 2nd generation hormone therapy (eg, abiraterone acetate or enzalutamide)
  • Patients may have been treated with a poly (ADP-ribose) polymerase inhibitor (PARP)
  • Performance Status <2
  • Metastatic disease progressive

Exclusion criteria

  • Absence of previous treatment with taxane in situation of sensitivity or resistance to castration.
  • Absence of previous treatment with cabazitaxel in case of resistance to castration (except contraindication explaining the non-administration of treatment)
  • No treatment with 2nd generation hormone therapy (eg abiraterone acetate or enzalutamide) unless contraindicated to explain non-administration of treatment
  • Previous treatment with platinum
  • Symptomatic and untreated central nervous system (CNS) metastases. Patients with asymptomatic and pre-treated CNS metastases are included if they are clinically stable (not requiring corticosteroid therapy for 28 days) and must have a brain MRI evaluation at screening and during follow-up.

Treatment and study plan

carboplatin

Drug

Tumoral evaluation every 3 cycles

Primary outcomes

  1. Efficacy of Carboplatin on Metastatic Prostatic Carcinoma Resistant to Castration Efficacy of Carboplatin: The Best Radiological Tumoral Response Rate

    Time frame: Up to 27 weeks (9 cycles)

    Tumoral response rate (TR) defined according to the recommendations of the PCWG3 criteria : Objective radiological response

  2. Efficacy of Carboplatin: Biological Response Rate Defined by Value of PSA

    Time frame: Up to 27 weeks (9 cycles)

    Biological response rate (TR) defined according to the recommendations of the PCWG3 criteria : Decrease of PSA ≥ 50%,

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • French Interregional Group of Clinical Research and Innovation
  • Ligue contre le cancer, France

Registry information

Official study title

Multicentre, Open-label Phase 2 Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway

Acronym: PRO-CARBO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2018
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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