Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617 (NCT06972628) | Clinical Trial Compass
RecruitingPhase 2
Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617
United States30 participantsStarted 2025-05-23
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a "super scan" pattern on a bone scan.
Pluvicto is FDA-approved, but patients with super scan bone scans were previously excluded from the VISION clinical trial, leaving a knowledge gap.
The study will enroll up to 30 men with metastatic castration-resistant prostate cancer, with an initial dosing approach that differs from the standard dose.
The safety and tolerability of PLUVICTO will be evaluated in this study, with a focus on identifying the optimal dose for this population.
This study addresses an important gap in understanding how Pluvicto performs in mCRPC patients with super scan findings.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
ā. Ability to understand and sign an informed consent form (ICF).
ā. Willingness and ability to comply with study requirements.
ā. Age ā„18 years.
ā. Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP/HDP bone scan, defined by significantly increased skeletal radioisotope uptake relative to soft tissues and faint or absent renal activity.
ā. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
ā. Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153, Rhenium- 186, Rhenium-188, Radium-223, hemi-body irradiation) within six months before start of treatment under this protocol.
What they're measuring
1
Radiographic progression-free survival
Timeframe: From date of enrollment until the date of first documented radiographic disease progression or date of death from any cause, whichever came first, assessed up to 24 months.
2
Overall Survival
Timeframe: From date of enrollment until the date of death from any cause, assessed up to 24 months.