Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617 in a Prostatectomy Model (LUTACT Trial)
Thomas Hope
Summary
There is evidence that Actinium-225 Prostate-Specific Membrane Antigen (225Ac-PSMA) has a potentially higher level of efficacy than 177 Lutetium Prostate-Specific Membrane Antigen (177Lu-PSMA) as a radioligand therapy. This single center, pilot study will compare differences in the mechanisms of actinium-225 and lutetium-177 radioligand therapies (RLT) in participants with high or very high risk localized or locoregional prostate cancer planning on undergoing a prostatectomy.
Description
PRIMARY OBJECTIVES: 1. Compare the tumor absorbed dose between 177Lu-PSMA-617 and 225Ac-PSMA-617. 2. Compare the immunologic priming of 177Lu-PSMA-617 and 225Ac-PSMA-617 with controls in prostatectomy specimens. SECONDARY OBJECTIVES: 1. Determine the safety and tolerability of neoadjuvant 177Lu-PSMA-617 and 225Ac-PSMA-617 in participants with high or very high-risk prostate cancer planning to undergo radical prostatectomy. 2. Estimate PSA response for 177Lu-PSMA-617 and 225Ac-PSMA-617 treatment. 3. Estimate the rate of pathologic response in participants treated with 177Lu-PSMA-617 and 225A…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically confirmed prostate adenocarcinoma. 2. Willing to undergo prostatectomy with or without lymph node dissection, and candidate for prostatectomy as determined by urologic oncology. 3. High-risk disease as defined as meeting 1 or more of the 3 following criteria: 1. Gleason score of 4+5 disease or higher. 2. Pelvic nodal metastases on PSMA PET. 3. Extracapsular extension or seminal vesicle invasion on MRI. 4. No evidence of distant metastatic disease as determined by PSMA PET. Nodal disease below the iliac bifurcation (clinical stage N1) is allowed.…
Interventions
- Drug177 Lutetium Prostate-Specific Membrane Antigen 617
Given intravenously (IV) or intra-arterially (IA)
- DrugActinium-225 Prostate-Specific Membrane Antigen 617
Given IV or IA
- ProcedureNon-investigational, Prostatectomy
Undergo non-investigational surgical procedure to remove prostate.
- ProcedureProstate Tissue Collection
Whole prostate tissue will be collected for correlative research at time of prostatectomy.
- ProcedureSingle-photon emission computed tomography (SPECT)/Computerized tomography (CT)
Imaging procedure
- ProcedureBlood Sample Collection
Blood samples will be obtained for research purposes
Location
- University of California, San FranciscoSan Francisco, California