Clincosm LogoSign in Get a demo

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

Sponsor
Centre Francois Baclesse (Other)
Overall Status
Terminated
CT.gov ID
NCT03652493
Collaborator
GIRCI (French Interregional Group of Clinical Research and Innovation) (Other), Ligue Contre le Cancer (French association Against Cancer) (Other)
16
Enrollment
4
Locations
1
Arm
31.5
Actual Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicentre, Open-label Phase 2 Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
Actual Study Start Date :
Sep 10, 2018
Actual Primary Completion Date :
Apr 27, 2021
Actual Study Completion Date :
Apr 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: CARBOPLATIN

CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles

Drug: Carboplatin
Tumoral evaluation every 3 cycles

Outcome Measures

Primary Outcome Measures

  1. Efficacy of carboplatin on metastatic prostatic carcinoma resistant to castration Efficacy of carboplatin: The best radiological tumoral response rate [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 [Up to 27 weeks (9 cycles)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre François Baclesse Caen France 14076
2 Centre Oscar Lambret Lille France 59000
3 Chu Rouen Rouen France 76000
4 Institut Gustave ROUSSy IGR Villejuif France

Sponsors and Collaborators

  • Centre Francois Baclesse
  • GIRCI (French Interregional Group of Clinical Research and Innovation)
  • Ligue Contre le Cancer (French association Against Cancer)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT03652493
Other Study ID Numbers:
  • 2017-004764-35
First Posted:
Aug 29, 2018
Last Update Posted:
Apr 30, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Francois Baclesse
Anomaly of the Homologous Recombination (HR) pathway
Carboplatin
Additional relevant MeSH terms:
Prostatic Neoplasms
Carboplatin

Study Results

No Results Posted as of Apr 30, 2021