Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Carboplatin: Carboplatin will be administered every 3 weeks at a dose of AUC 5 ( 5 x eGFR calculated by Cockroft Gault formula).
This will be continued till progression or intolerable
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: Histological diagnosis of prostate cancer Serum testosterone Documented current evidence of metastatic castration-resistant prostate cancer Prior treatment with docetaxel and at least one of the novel anti-androgen agent (abiraterone and enzalutamide) Mutation (germline or somatic) in the HRR pathway in either blood or biopsy sample, respectively Written informed consent to participate Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 Adequate organ functions
Exclusion criteria
Exclusion criteria: Patients with symptomatic brain metastases. A scan to confirm the absence of brain metastases isnot required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days. Patients unevaluable for both bone and soft tissue progression as defined by meeting both of the following criteria: A bone scan referred to as a superscan showing an intense symmetric activity in the bones No soft tissue lesion (measurable or non-measurable) that can be assessed by RECIST Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection. Patients with a known hypersensitivity to carboplatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess response rate of three weekly carboplatin (AUC5) in patients with mCRPC harboring deleterious mutations in HRR genes and previously treated with a taxane and a novel anti-androgen (proportion of patients with more than 50% serum PSA decline)Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess progression free survival (PFS) (soft-tissue disease progression [by RECIST, version 1.1], bone lesion progression (by Prostate Cancer Clinical Trials Working Group 3 criteria)Timepoint: 6 months;To assess health-related quality of life during carboplatin treatment (FACT-P questionnaire)Timepoint: 6 months;Safety profile of carboplatin (NCI CTCAE version 4.0)Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactAtul Batra
AIIMS
Outcome results
None listed