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Trial record 1 of 1 for:    Prostate Cancer | pro carbo | France
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Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway (PRO-CARBO)

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ClinicalTrials.gov Identifier: NCT03652493
Recruitment Status : Terminated (lack of efficacy)
First Posted : August 29, 2018
Last Update Posted : April 30, 2021
Sponsor:
Collaborators:
GIRCI (French Interregional Group of Clinical Research and Innovation)
Ligue Contre le Cancer (French association Against Cancer)
Information provided by (Responsible Party):
Centre Francois Baclesse

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
Castration-resistant Prostate Cancer Metastasis Drug: Carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : September 10, 2018
Actual Primary Completion Date : April 27, 2021
Actual Study Completion Date : April 27, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin

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




Primary Outcome Measures :
  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%,



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652493


Locations
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France
Centre François Baclesse
Caen, France, 14076
Centre Oscar Lambret
Lille, France, 59000
Chu Rouen
Rouen, France, 76000
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)
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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT03652493    
Other Study ID Numbers: 2017-004764-35
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Carboplatin
Antineoplastic Agents