Actively Recruiting
Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617
Led by Thomas Hope · Updated on 2026-04-01
45
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
Sponsors
T
Thomas Hope
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate adenocarcinoma.
- Willingness to undergo prostatectomy with or without lymph node dissection as determined by a urologic oncologist.
- High-risk prostate cancer defined by at least one of the following: Gleason score 4+5 or higher; pelvic nodal metastases on PSMA PET; extracapsular extension or seminal vesicle invasion on MRI.
- No evidence of distant metastatic disease by PSMA PET; nodal disease below the iliac bifurcation (clinical stage N1) is allowed.
- Primary tumor with maximum Standardized Uptake Value (SUVmax) greater than 10 on PSMA PET using 68Ga-PSMA-11 or 18F-DCFPyL.
- Target tumor in the prostate measuring greater than 1.5 cm on MRI.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky score 60% or higher).
- Adequate organ function including platelets ≥100,000/mcL, hemoglobin ≥10 g/dL, absolute neutrophil count ≥1,500/mcL, creatinine clearance (GFR) ≥60 mL/min/1.73 m², albumin ≥2.5 g/dL, ALT or AST ≤3.0 times upper limit of normal, total bilirubin ≤2 times upper limit of normal (≤3 times if Gilbert's Syndrome).
- Ability to understand and willing to sign informed consent.
- Agreement to comply with recommended radioprotection precautions.
- Use of adequate contraception and agreement not to donate sperm during the study and for at least 14 weeks after last treatment.
You will not qualify if you...
- Prior prostate cancer therapy (except 5-alpha reductase inhibitors discontinued at least 3 weeks before treatment).
- Participation in a study of an investigational therapeutic product or device within 4 weeks before first treatment dose.
- Dry mouth affecting eating (requiring mouthwash before meals).
- Serious concurrent medical conditions including NYHA class III or IV heart failure, congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbidities that may impair participation.
- Diagnosed with other malignancies expected to affect life expectancy or interfere with disease assessment, except adequately treated malignancies disease-free for over 3 years or certain skin and bladder cancers.
- Prior external beam radiation therapy to the prostate or prostate bed.
- For participants receiving intra-arterial administration: severe allergy to iodinated contrast, severe atherosclerosis by prior CT imaging, or greater than 10 pack-year smoking history if no prior imaging available.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
M
Maya Aslam
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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