Castration-resistant Prostate Cancer, Metastasis
Conditions
Keywords
Anomaly of the Homologous Recombination (HR) pathway, Carboplatin
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
Interventions
DRUGCarboplatin
Tumoral evaluation every 3 cycles
Sponsors
Centre Francois Baclesse
French Interregional Group of Clinical Research and Innovation
Ligue contre le cancer, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%, |
Countries
France
Participant flow
Pre-assignment details
One patient dropped out of the study before starting treatment due to rapid deterioration of general condition.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67 years |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 15 |
| other Total, other adverse events | 15 / 15 |
| serious Total, serious adverse events | 6 / 15 |
Outcome results
None listed