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

Phase 2

Terminated

• Conditions: Castration-resistant Prostate Cancer; Metastasis
• Interventions: Drug: Carboplatin

• Registration Number: NCT03652493
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-29
• Study Start: 2018-09-10
• Status Verified: 2021-04
• Primary Completion: 2021-04-27
• Study Completion: 2021-04-27
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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
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%,

Trial Locations

Locations (4)

Chu Rouen; 🇫🇷 Rouen, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut Gustave ROUSSy IGR; 🇫🇷 Villejuif, France

Centre François Baclesse; 🇫🇷 Caen, France