A Phase 2 Study of Biomarker-Modulated PSMA Theranostics
University of Washington
Summary
This phase II trial tests how well 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that remains despite treatment (resistant). Lutetium Lu 177 (177Lu), the radioactive (tracer) component being delivered by prostate-specific membrane antigen (PSMA)-617, has physical properties that make it ideal radionuclide (imaging tests that uses a small dose tracer) for treatment of metastatic castrate-resistant prostate cancer (mCRPC). 177Lu-PSMA-617 works by binding to prostate cancer cells and inducing damage to deoxyribonucleic acid (DNA) inside prostate cancer cells. Giving 177Lu-PSMA-617 may improve treatment outcomes for patients with mCRPC.
Description
OUTLINE: Patients receive 177Lu-PSMA-617 intravenously (IV) over 30 minutes on days 1, 8, 50, 57, 99 and 141. Treatment repeats every 7 days for cycles 1 and 3 and every 6 weeks for cycle 2 and subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA positron emission tomography/computed tomography (PET/CT) during screening and single photon emission computed tomography (SPECT)/CT on study. Patients also undergo CT or magnetic resonance imaging (MRI), bone scan, as well as blood sample collection throughout the study. After co…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have the ability to understand and sign an approved informed consent. * Patients must have the ability to understand and comply with all protocol requirements. * Patients must be ≥ 18 years of age. * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Patients must have a life expectancy \> 6 months. * Patients must have histological, pathological, and/or cytological confirmation of prostate cancer. * Patients must have a positive 68Ga-PSMA PET/CT scan with no PSMA negative lesion, as determined by the Nuclear Med…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Scan
Undergo bone scan
- ProcedureComputed Tomography
Undergo SPECT/CT and CT
- DrugLutetium Lu 177 Vipivotide Tetraxetan
Given IV
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePSMA PET-CT Scan
Undergo PSMA PET/CT
- OtherQuestionnaire Administration
Locations (3)
- University of California San FranciscoSan Francisco, California
- Olive View-University of California Los Angeles Medical CenterSylmar, California
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington