Metastasis Clinical Trial
— PRO-CARBOOfficial title:
Multicentre, Open-label Phase 2 Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
Verified date | April 2021 |
Source | Centre Francois Baclesse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
Country | Name | City | State |
---|---|---|---|
France | Centre François Baclesse | Caen | |
France | Centre Oscar Lambret | Lille | |
France | Chu Rouen | Rouen | |
France | Institut Gustave ROUSSy IGR | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Centre Francois Baclesse | GIRCI (French Interregional Group of Clinical Research and Innovation), Ligue Contre le Cancer (French association Against Cancer) |
France,
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) |
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