NCT07054346 Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617
| NCT ID | NCT07054346 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Thomas Hope |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-07-08 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2025-07-08 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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. 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 1.5 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: 1. Has received prior prostate cancer therapy. 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. 7. Prior external beam radiation therapy (EBRT) to the prostate or prostate bed. Additional exclusion criteria applicable only to participants undergoing intraarterial administration of PSMA RLT: 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.
Contact & Investigator
Thomas A Hope, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07054346 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07054346 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07054346 currently recruiting?
Yes, NCT07054346 is actively recruiting participants. Contact the research team at Maya.Aslam@ucsf.edu for enrollment information.
Where is the NCT07054346 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07054346 clinical trial?
NCT07054346 is sponsored by Thomas Hope. The principal investigator is Thomas A Hope, MD at University of California, San Francisco. The trial plans to enroll 45 participants.
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