Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)

In advanced metastatic castration resistant prostate cancer (mCRPC) progressing after chemotherapy and androgen receptor (AR)-targeted therapy 177Lu-PSMA-617 is an effective treatment. 177Lu-PSMA-617 RLT is administered with a fixed schedule: 6 treatment cycles, administered every 6 weeks. However, the optimum number of cycles of 177Lu-PSMA in patients who show good response remains unknown. Some patients may benefit from more than 6 cycles of therapy. Additionally, some patients experience a complete or almost complete response before the last cycle. It is unclear whether these patients benef

Trial Details

NCT ID
NCT06216249
Phase
PHASE2
Sponsor
Jonsson Comprehensive Cancer Center
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Computed Tomography
  • Gallium Ga 68 Gozetotide
  • Lutetium Lu 177 Vipivotide Tetraxetan
  • Positron Emission Tomography
  • PSMA PET Scan
  • Questionnaire Administration
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • Patients must have prostate cancer proven by histopathology
  • Patients must have ≥ 1 metastatic lesion by any imaging (CT, magnetic resonance imaging \[MRI\], bone scan, PET)
  • Patients must have received at least one regimen of chemotherapy for mCRPC
  • Patients must have received at least one androgen-receptor signaling inhibitors (ARSI)

For full eligibility, visit ClinicalTrials.gov.

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