Thomas Hope
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.
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…
Inclusion Criteria: 1. Age ≥18 years. 2. Histologically confirmed prostate adenocarcinoma. 3. High-risk disease as defined as meeting 1 or more of the 3 following criteria: 1. Gleason score of 4+4 disease or higher, Or Gleason 4+3 with large cribriform component (defined as \>0.25 mm in short diameter) 2. Pelvic nodal metastases on PSMA PET. 3. Extracapsular extension or seminal vesicle invasion on MRI or PSMA PET. 4. No evidence of distant metastatic disease as determined by PSMA PET. Nodal disease at or below the iliac bifurcation (clinical stage N1) is allowed. 5. Maximum Standar…
Given intravenously (IV) or intra-arterially (IA)
Given IV or IA
Undergo non-investigational surgical procedure to remove prostate.
Whole prostate tissue will be collected for correlative research at time of prostatectomy.
Imaging procedure
Blood samples will be obtained for research purposes
Arctuva estimate
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