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NCT06200103 · ClinicalTrials.gov record · last posted 2026-08-20

Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer

StatusSuspended
PhasePhase 2
Started2024-05-03
View on ClinicalTrials.gov ↗
Why the trial stopped
Pending additional funding.
from the ClinicalTrials.gov record
This phase II trial studies how to improve the usage of Lu 177 vipivotide tetraxetan (177Lu-prostate-specific membrane antigen \[PSMA\]-617) for treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site), to other places in the body (metastatic) utilizing a treatment pause after 5 cycles of therapy versus standard continuous treatment for 6 cycles. Lutetium is a radioligand therapy (RLT). RLT uses a small molecule (in this case 177Lu-PSMA-617) that carries a radioactive component to destroy tumor cells. When lutetium is injected into the body, it attaches to the PSMA receptor found on tumor cells. After lutetium attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving 177Lu-PSMA-617 for 5 cycles versus 6 cycles may better treat patients with metastatic castrate resistant prostate cancer.

Protocol amendment history 2 changes detected by DataLookout

2026-08-21
Recruitment suspended
2026-08-21
Recruitment suspended: Pending additional funding.
Trial Details
NCT Number NCT06200103
Lead Sponsor Mayo Clinic
Conditions Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Enrollment 236 participants
Start Date 2024-05-03
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-20