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

Metastasis Clinical Trial

— PRO-CARBO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03652493
• Other study ID #: 2017-004764-35
• Status: Terminated
• Phase: Phase 2
• Start date: September 10, 2018
• Est. completion date: April 27, 2021

Study information

• Verified date: April 2021
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: April 27, 2021
• Est. primary completion date: April 27, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Metastasis
• Prostatic Neoplasms

Intervention

Drug:
• Carboplatin
Tumoral evaluation every 3 cycles

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	Centre Oscar Lambret	Lille
France	Chu Rouen	Rouen
France	Institut Gustave ROUSSy IGR	Villejuif

Sponsors (3)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)