Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: 177Lu-PSMA-617 plus Enzalutamide: Enzalutamide 160 mg/day orally for 7 days prior to 177Lu-PSMA-617 intravenous therapy and continued for 7 days after the therapy
177Lu-PSMA-617 intravenously, approximately 7.4 GBq (200 mCi) per cycle and 4-6 cycles at 6-8 weekly intervals for 8-12 months
Control Intervention1: Nil: Nil
Sponsors
Post Graduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histopathologically proven cases of mCRPC 2.Prior history of treatment with at least one taxane with/without androgen receptor pathway inhibitors 3.Candidates for 177Lu-PSMA-617 therapy with ECOG score â?¤2 and KPS â?¥60 and sufficient organ function reserve 4.PSMA avid mCRPC on pre-therapy PSMA PET/CT (as per the VISION criteria) 5.Willing to give consent to participate in the study
Exclusion criteria
Exclusion criteria: 1.Patients refusing to give written informed consent 2.Life expectancy less than three months 3.Liver dysfunction (ALT/AST â?¥2.0 x ULN (or â?¥5.0 x ULN in the presence of liver metastases) 4.Kidney dysfunction (eGFR 2 times upper limit of normal) 5.Total leukocyte count 6.Past history of major cardiovascular or cerebrovascular events 7.Past history of seizures 8.Unacceptable toxicity to enzalutamide (if received earlier)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best PSA (prostate specific antigen) response rateTimepoint: Serum PSA (prostate specific antigen) will be measured at baseline and every 3 weeks following each cycle. PSA response rate will be defined according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) as proportion of patients achieving a â?¥50% decline in PSA from baseline. . | — |
Secondary
| Measure | Time frame |
|---|---|
| Best Objective Response RateTimepoint: Radiological response will be assessed on the CT images of 68Ga-PSMA PET/CT as per RECIST 1.1. 68Ga-PSMA-11 PET/CT will be performed at 6 weeks after every 2 cycles at 10-12 weeks of 177Lu-PSMA-617. The proportions of patients achieving complete response (CR) and partial response (PR) will be combined as the Objective Response Rate.;Best Molecular Response RateTimepoint: Molecular response will be assessed on the 68Ga-PSMA-11 PET/CT as per the adapted PERCIST 1.0. 68Ga-PSMA PET/CT will be performed at 6 weeks after every 2 cycles at 10-12 weeks of 177Lu-PSMA-617. The proportions of patients achieving complete response (CR) and partial response (PR) will be combined as the Molecular Response Rate.;Health related quality of life outcomesTimepoint: Assessed using NCCN FACT FPSI 17 questionnaire, Version 2 (FACIT.org, Ponte Vedra, Florida, USA) at baseline and every 2 cycles at 10-12 weeks;Frequency of Adverse eventsTimepoint: Adverse events will be assessed using CTCAE version 5.0. Complete blood count, serum urea, creatinine, electrolytes, liver function tests, fasting plasma glucose, lipid profile, blood pressure, ECG will be measured every 3 weeks following each cycle.;Progression-free survivalTimepoint: Time to biochemical progression or radiological progression or death. Biochemical progression will be defined as per the PCWG3 criterion: rise in PSA by more than 25% and more than 2ng/mL above the nadir; to be confirmed by a repeat PSA at least 3 weeks late; early rises in PSA prior to 12 weeks of initiation of treatment will, however, be disregarded in determining PSA progression. Radiological progression will be defined as per the RECIST 1.1 and PCWG3.;Overall survivalTimepoint: Estimated from the start of treatment regimen till death due to any cause.;DosimetryTimepoint: Lesion absorbed dose estimated at 24 hours after each 177Lu-PSMA-617 therapy given at 6-8 weeks | — |
Countries
India
Contacts
Public ContactASHWANI SOOD
PGIMER
Outcome results
None listed