Study Title
A Phase 2 Randomized Trial in Patients With Metastatic Castration Resistant Prostate Cancer to Determine the Efficacy of a Flexible Dosing Schedule of Lu-PSMA Treatment up to 12 Cycles Including Potential Treatment Holiday Periods in Comparison to the Standard Fixed Dosing Schedule of Six Cycles Every Six Weeks (FLEX-MRT)
Study Details
Description:
The randomized phase 2 FLEX MRT compares a group of patients treated with LuPSMA on a flexible and extended dosing schedule including "treatment holiday" periods (investigational arm, up to 12 cycles) to a control group treated with a fixed dosing schedule of 6 treatments cycles maximum administered every 6 weeks. The flexible dosing schedule in the investigational arm, will be based on SPECT/CT response assessments obtained 24h after injection of LuPSMA therapy cycle. The response assessment during treatment holiday period will be based on PET/CT every 12 weeks.
Sponsor:
Jonsson Comprehensive Cancer Center (UCLA)
Contacts:
Hamzah Alam (Clinical Research Coordinator)halam@mednet.ucla.edu
3102067372
Maria Contreras (Clinical Research Coordinator)mmcontreras@mednet.ucla.edu
310-825-7336
Government Study Link:
NCT06216249 - Click here to see study onClinicalTrials.gov
Drug Details
- LUTETIUM-177
- GALLIUM-68
- PSMA
- PSMA PET/CT must be performed within 8 weeks of planned first cycle of 177Lu-PSMA-617.
- Patients must have ≥ 1 metastatic lesion by any imaging (CT, magnetic resonance imaging [MRI], bone scan, PET)
- Patients must have received at least one androgen-receptor signaling inhibitors (ARSI)
- Patients must have received at least one regimen of chemotherapy for mCRPC
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Glomerular filtration rate (GFR) < 50 ml/min
- Less than 6 weeks between last myelosuppressive therapy
- Urinary tract obstruction or marked hydronephrosis
- Prior cycle of 177Lu-PSMA-617 therapy
Patient Education
Patient Education Not Yet Provided
Publications
Publications Not Yet Provided
