Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Lu-PSMA-617 plus rucaparib: 177Lu-PSMA-617 200 mCi per cycle IV, up to 4 cycles, 8�±2 weeks apart
Oral Rucaparib 200 mg/day, days 1-15 of each cycle
Control Intervention1: Lu-PSMA-617: 177Lu-PSMA-617 200 mCi per cycle IV, up to 4 cycles, 8�±2 weeks apart
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Age ââ?°Â¥18 years with written informed consent Histologically-proven adenocarcinoma prostate Castration-resistant prostate cancer defined by castrate serum testosterone Metastatic disease (as established by 68Ga-PSMA-11 PET/CT) Significant PSMA expression in 68Ga-PSMA-11 PET/CT defined as tracer avidity of at least 80% of the lesions being significantly (1.5x) greater than that of normal liver with none of the lesions having uptake less than that of liver Disease progression following at least one line of taxane-based chemotherapy or one of the novel androgen-axis drugs (abiraterone/ enzalutamide) At least 4 weeks following the completion of any surgery or radiotherapy prior to recruitment ECOG performance 0-2 Life expectancy ââ?°Â¥ 12 weeks Adequate renal function ââ?¬â?? eGFR ââ?°Â¥ 30 mL/min Stable haematological parameters: Hb ââ?°Â¥ 9 g/dL Neutrophils ââ?°Â¥ 1500/mcL Platelets ââ?°Â¥ 75000/mcL Adequate liver function: o Bilirubin o AST or ALT ââ?°Â¤ 1.5 x ULN (or ââ?°Â¤ 5.0 x ULN in the presence of liver metastases) o Albumin ââ?°Â¥ 2.5 g/dL
Exclusion criteria
Exclusion criteria: Prostate cancer with sarcomatous/spindle cell/small cell differentiation Sjogren Syndrome Prior treatment with 177Lu-PSMA-RLT/ 225Ac-PSMA-RLT/ PARP inhibitors/ platinum-based chemotherapy/ mitoxantrone/ cyclophosphamide Patients with symptomatic or impending spinal cord compression unless treated prior to recruitment and clinically stable for �4 weeks Active malignancy other than prostate cancer Concurrent illness, including severe infection Patients unable to swallow oral medications or with malabsorption disorders Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception Known hypersensitivity to rucaparib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best PSA response rate: Defined according to Prostate Cancer Clinical Trials Working Group 3 (PCWG) as proportion of patients achieving a ââ?°Â¥50% decline in PSA from baselineTimepoint: Best PSA response rate: Defined according to Prostate Cancer Clinical Trials Working Group 3 (PCWG) as proportion of patients achieving a ââ?°Â¥50% decline in PSA from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Health related quality of life outcomesTimepoint: Assessed using NCCN-FACT-FPSI-17 questionnaire, Version 2 (FACIT.org, Ponte Vedra, Florida, USA) at baseline and 12 weeks following treatment initiation;Molecular response rateTimepoint: Assessed at 12 and 24 weeks after treatment initiatio;Objective response rateTimepoint: Assessed at 12 and 24 weeks after treatment initiation;Overall SurvivalTimepoint: To be measured from the date of treatment initiation to death due to any cause;Progression-free survivalTimepoint: Estimated from the initiation of the treatment till documented biochemical progression or radiological progression or death. Biochemical progression defined as per the PCWG3 criterion. Radiological progression will be defined as per the RECIST 1.1 for soft tissue lesions and PCWG3 for bone lesions. Follow-up every 3 months till 2 years after enrolment of last patient;Proportion of serious and non-serious adverse events, assessed using CTCAE version 5.0Timepoint: Assessed every 3 weeks till 24 weeks, then 3 monthly till 12 months after treatment initiation | — |
Countries
India
Contacts
Public ContactChandrasekhar Bal
All india Institute of Medical Sciences New Delhi
Outcome results
None listed