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Completed
NCT03652493
Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
Conditions: Castration-resistant Prostate Cancer, Metastasis
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 16
Sponsor: Centre Francois Baclesse
Location: Centre François Baclesse Caen
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
Eligibility 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 \
Source: ClinicalTrials.gov (NCT03652493). StuddyBuddy aggregates publicly available trial information.