Carboplatin in advanced prostate cancer with DNA repair mutations
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2023/04/051507
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Histological diagnosis of prostate cancer
Serum testosterone < 50 ng/dL within 28 days before screening
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess response rate of three weekly carboplatin (AUC5) in patients with mCRPC harboring <br/ ><br>deleterious mutations in HRR genes and previously treated with a taxane and a novel anti-androgen <br/ ><br>(proportion of patients with more than 50% serum PSA decline)Timepoint: 6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method Safety profile of carboplatin (NCI CTCAE version 4.0)Timepoint: 6 months;To assess health-related quality of life during carboplatin treatment (FACT-P questionnaire)Timepoint: 6 months;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