Study Results
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Basic Information
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RECRUITING
PHASE1
45 participants
INTERVENTIONAL
2025-07-08
2028-04-30
Brief Summary
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Detailed Description
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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 225Ac-PSMA-617.
EXPLORATORY OBJECTIVES:
1. Determine the relationship between percent cell necrosis and tumor absorbed dose for both 177Lu-PSMA-617 and 225Ac-PSMA-617.
2. Compare the heterogeneity of cell necrosis for 177Lu-PSMA-617 and 225Ac-PSMA-617.
3. Compare messenger ribonucleic acid (mRNA) expression profiles of tumor treated with 177Lu-PSMA-617, 225Ac-PSMA-617, and controls.
4. Compare mRNA expression profiles of tumors in participants who achieve a PSA50 response and those that do not.
5. Compare mRNA expression profiles of tumors from archival tissue and at time of prostatectomy.
6. Compare the percent cell necrosis between participants receiving a single cycle of PSMA RLT versus participants receiving two cycles of PSMA RLT.
7. Compare the change in uptake on PSMA Positron Emission Tomography (PET) to PSA response and percent cell necrosis.
8. Descriptively evaluate cell necrosis at the tumor margins.
OUTLINE:
Participants will be assigned to 1 of 2 cohorts to receive 177Lu-PSMA-617 or 225Ac-PSMA-617. Additional participants undergoing prostatectomy without RLT will be enrolled as a control group. Participants enrolled in the RLT cohorts will receive 1 to 2 cycles of PSMA radioligand therapy up to 6 weeks apart before a scheduled, non-investigational, prostatectomy four weeks after PSMA radioligand therapy. Participants receiving RLT will be followed up for a safety assessment 6 weeks after surgery and for up to 60 months after prostatectomy for long term follow-up. Participants in the prostatectomy only cohort will have safety and long-term follow-up performed as part of clinical care up to 24 months after surgery.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 (177Lu-PSMA-617)
Five participants will receive a single dose of 177Lu-PSMA-617 radioligand therapy intravenously (IV), five participants will receive a single dose of 177Lu-PSMA-617 intra-arterially (IA), and five participants will receive two doses over 6 weeks intravenously. In participants receiving two doses, the dose will be divided so that the cumulative dose will be equivalent to participants receiving a single dose. All participants will undergo prostatectomy four weeks after completing radioligand therapy and will be followed up 6 weeks after surgery for safety assessments and at 3, 6, 12, and 60 months for long-term outcomes.
177 Lutetium Prostate-Specific Membrane Antigen 617
Given intravenously (IV) or intra-arterially (IA)
Non-investigational, Prostatectomy
Undergo non-investigational surgical procedure to remove prostate.
Prostate Tissue Collection
Whole prostate tissue will be collected for correlative research at time of prostatectomy.
Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)
Imaging procedure
Blood Sample Collection
Blood samples will be obtained for research purposes
Cohort 2 (225Ac-PSMA-617)
Five participants will receive a single dose of 225Ac-PSMA-617 radioligand therapy IV, five participants will receive a single dose of 225Ac-PSMA-617 IA, and five participants will receive two doses over 6 weeks IV. In participants receiving two doses, the dose will be divided so that the cumulative dose will be equivalent to participants receiving a single dose. All participants will undergo prostatectomy four weeks after completing radioligand therapy and will be followed up 6 weeks after surgery for safety assessments and at 3, 6, 12, and 60 months for long-term outcomes.
Actinium-225 Prostate-Specific Membrane Antigen 617
Given IV or IA
Non-investigational, Prostatectomy
Undergo non-investigational surgical procedure to remove prostate.
Prostate Tissue Collection
Whole prostate tissue will be collected for correlative research at time of prostatectomy.
Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)
Imaging procedure
Blood Sample Collection
Blood samples will be obtained for research purposes
Control Group (Prostatectomy only)
Participants will obtain a non-investigational prostatectomy. Tumor tissue obtained at the time of surgery will be utilized for comparisons with the cohorts receiving study therapies. All participants will undergo prostatectomy four weeks after completing radioligand therapy and will be followed up 6 weeks after surgery for safety assessments and up to 24 months after surgery.
Non-investigational, Prostatectomy
Undergo non-investigational surgical procedure to remove prostate.
Prostate Tissue Collection
Whole prostate tissue will be collected for correlative research at time of prostatectomy.
Blood Sample Collection
Blood samples will be obtained for research purposes
Interventions
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177 Lutetium Prostate-Specific Membrane Antigen 617
Given intravenously (IV) or intra-arterially (IA)
Actinium-225 Prostate-Specific Membrane Antigen 617
Given IV or IA
Non-investigational, Prostatectomy
Undergo non-investigational surgical procedure to remove prostate.
Prostate Tissue Collection
Whole prostate tissue will be collected for correlative research at time of prostatectomy.
Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)
Imaging procedure
Blood Sample Collection
Blood samples will be obtained for research purposes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
5. Maximum Standardized Uptake Value (SUVmax) in the primary tumor greater than 10 on PSMA PET using Gallium-68 (68Ga)-PSMA-11 or piflufolastat F 18 (18F-DCFPyL).
6. Target tumor in the prostate measuring greater than 2 cm on MRI.
7. Age ≥18 years.
8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%),
9. Demonstrates adequate organ function as defined below:
1. Platelets ≥100,000/mcL, independent of transfusions or growth factors within 3 months of treatment start.
2. Hemoglobin ≥10 g/dL, independent of transfusions or growth factors within 3 months of treatment start.
3. Absolute Neutrophil Count (ANC) ≥1,500/microliter (mcL).
4. Creatinine clearance Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2 , calculated using the Cockcroft-Gault equation.
5. Albumin ≥2.5 g/dL.
6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN.
7. Total bilirubin (TBIL) ≤2 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted.
10. Ability to understand and the willingness to sign a written informed consent document.
11. Participants must provide consent to comply to recommended radioprotection precautions during study.
12. Participants must use adequate contraception and not donate sperm while on study drug and for at least 14 weeks after the last study treatment.
Exclusion Criteria
a. Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3 weeks prior to treatment start.
2. Has participated in a study of an investigational therapeutic product and received study treatment or used an investigational device within four weeks of the first dose of treatment.
3. Dry mouth that impacts the eating of food (i. e. requiring mouthwash prior to eating).
4. Concurrent serious (as determined by the principal investigator) medical conditions including but not limited to New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
5. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free, treatment free for more than 3 years prior to randomization, or participants with adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible.
6. Individuals with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
1. Severe allergy to iodinated contrast.
2. Severe atherosclerosis from prior CT imaging study, or greater than 10 pack-year smoking history if no prior imaging available.
18 Years
MALE
No
Sponsors
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Novartis
INDUSTRY
Thomas Hope
OTHER
Responsible Party
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Thomas Hope
Professor In Residence
Principal Investigators
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Thomas A Hope, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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25922
Identifier Type: -
Identifier Source: org_study_id
NCI-2025-04497
Identifier Type: REGISTRY
Identifier Source: secondary_id
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