Actively Recruiting
Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617 in a Prostatectomy Model (LUTACT Trial)
Led by Thomas Hope · Updated on 2026-04-01
45
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
Thomas Hope
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying men with high or very high-risk localized or locoregional prostate cancer who plan to undergo prostatectomy. The trial compares two types of radioligand therapies: Actinium-225 Prostate-Specific Membrane Antigen (225Ac-PSMA) and Lutetium-177 Prostate-Specific Membrane Antigen (177Lu-PSMA). The goal is to evaluate differences in how these treatments work and their effects on the tumor and immune response before surgery. Participants will be assigned to one of two groups receiving 177Lu-PSMA-617 or 225Ac-PSMA-617. Each group includes subgroups receiving treatments intravenously or intra-arterially, with some receiving one dose and others two doses over six weeks. All participants in these groups will have prostatectomy about four weeks after completing radioligand therapy. A control group will undergo prostatectomy without prior radioligand treatment. Those receiving therapy will be monitored for safety six weeks after surgery and followed for up to 60 months; control group participants will be followed for 24 months. During the study, participants will undergo blood sample collection, imaging scans including PSMA PET and SPECT/CT, and prostate tissue collection at surgery for research comparisons. Researchers will measure tumor absorbed radiation dose, immune cell infiltration, prostate specific antigen (PSA) response, and pathologic response. Safety, side effects, quality of life related to dry mouth, and long-term outcomes will be assessed. The study includes detailed follow-up visits to monitor health and changes over time.
CONDITIONS
Brief Title
Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate adenocarcinoma.
- Willing to undergo prostatectomy with or without lymph node dissection as determined by urologic oncology.
- High-risk disease defined by at least one: Gleason score 4+5 or higher, pelvic nodal metastases on PSMA PET, or extracapsular extension or seminal vesicle invasion on MRI.
- No distant metastatic disease on PSMA PET; nodal disease below iliac bifurcation allowed.
- Primary tumor with SUVmax greater than 10 on PSMA PET using Gallium-68 or piflufolastat F 18.
- Target tumor larger than 1.5 cm on MRI.
- Male aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less.
- Adequate organ function including platelet count, hemoglobin, neutrophil count, kidney function, albumin, liver enzymes, and bilirubin within specified limits.
- Ability to understand and sign informed consent.
- Willingness to comply with radioprotection precautions.
- Use of adequate contraception and agreement not to donate sperm during and for 14 weeks after study treatment.
You will not qualify if you...
- Prior prostate cancer therapy (except 5-alpha reductase inhibitors stopped at least 3 weeks prior).
- Participation in an investigational study with treatment or device use within 4 weeks before first dose.
- Dry mouth that affects eating.
- Serious medical conditions such as advanced heart failure, congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbidities.
- Other malignancies affecting life expectancy or disease assessment, except adequately treated and disease-free for over 3 years.
- Prior external beam radiation therapy to the prostate or prostate bed.
- For intraarterial administration groups: severe allergy to iodinated contrast or severe atherosclerosis or heavy smoking history if no imaging available.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks between doses plus 4 weeks until prostatectomy
Participants receive 1 to 2 cycles of 177Lu-PSMA-617 or 225Ac-PSMA-617 radioligand therapy intravenously or intra-arterially up to 6 weeks apart before prostatectomy. Participants in the control group undergo prostatectomy without radioligand therapy.
1 to 2 treatment visits depending on dosing schedule
Duration - Surgery day plus immediate recovery period
Participants undergo a non-investigational prostatectomy four weeks after completing radioligand therapy or as scheduled for the control group. Prostate tissue is collected at surgery for research purposes.
1 visit (in-person) for surgery
Duration - 6 weeks to 60 months after surgery
Participants are followed for safety assessments 6 weeks after surgery. Long-term follow-up continues for up to 60 months after prostatectomy for those receiving radioligand therapy and up to 24 months for the control group.
Multiple visits at 6 weeks, 3, 6, 12, 36, 48, and 60 months (timing varies by group)
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
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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