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

NCT03652493 | Completed Phase 2

• 1 other identifier: 2017-004764-35
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

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

Conditions

Castration-resistant Prostate Cancer; Metastasis

Keywords

Anomaly of the Homologous Recombination (HR) pathway; Carboplatin

Outcome Measures

Primary Outcomes (2)

• Efficacy of carboplatin on metastatic prostatic carcinoma resistant to castration Efficacy of carboplatin: The best radiological tumoral response rate

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

  Up to 27 weeks (9 cycles)

• Efficacy of carboplatin: biological response rate defined by value of PSA

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

  Up to 27 weeks (9 cycles)

Study Arms (1)

CARBOPLATIN

EXPERIMENTAL

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

Drug: Carboplatin

Interventions

Carboplatin DRUG

Tumoral evaluation every 3 cycles

CARBOPLATIN

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Centre François Baclesse

Caen, 14076, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Chu Rouen

Rouen, 76000, France

Location

Institut Gustave ROUSSy IGR

Villejuif, France

Location

Related Publications (1)

• Coquan E, Penel N, Lequesne J, Leman R, Lavaud P, Neviere Z, Brachet PE, Meriaux E, Carnot A, Boutrois J, Castera M, Goardon N, Muller E, Leconte A, Thiery-Vuillemin A, Clarisse B, Joly F. Carboplatin in metastatic castration-resistant prostate cancer patients with molecular alterations of the DNA damage repair pathway: the PRO-CARBO phase II trial. Ther Adv Urol. 2024 Feb 28;16:17562872241229876. doi: 10.1177/17562872241229876. eCollection 2024 Jan-Dec.

  PMID: 38425504 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 29, 2018
• Study Start: September 10, 2018
• Primary Completion: April 27, 2021
• Study Completion: May 21, 2021
• Last Updated: October 6, 2025

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)