Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617

Part of paid clinical trials in San Francisco, California.

Sponsor
Thomas Hope
Study ID
NCT07054346
Phase
PHASE1
Status
Recruiting
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Conditions

  • High-risk Prostate Cancer
  • Localized Prostate Carcinoma
  • Prostate Cancer
  • Prostate Cancer (Diagnosis)
  • Very High Risk Prostate Carcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 177 Lutetium Prostate-Specific Membrane Antigen 617 — DRUG
    Given intravenously (IV) or intra-arterially (IA)
  • Actinium-225 Prostate-Specific Membrane Antigen 617 — DRUG
    Given IV or IA
  • Non-investigational, Prostatectomy — PROCEDURE
    Undergo non-investigational surgical procedure to remove prostate.
  • Prostate Tissue Collection — PROCEDURE
    Whole prostate tissue will be collected for correlative research at time of prostatectomy.
  • Single-photon emission computed tomography (SPECT)/Computerized tomography (CT) — PROCEDURE
    Imaging procedure
  • Blood Sample Collection — PROCEDURE
    Blood samples will be obtained for research purposes

Study Details

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.

Key Dates

Start date
Jul 8, 2025
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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, 36, 48, and 60 months for long-term outcomes.
  • Experimental: 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, 36, 48, and 60 months for long-term outcomes.
  • Other: 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.

Primary Outcome Measure

Mean of tumor absorbed dose (Cohorts 1 and 2) [ Time Frame: 1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Maya Aslam
[email protected]
415-514-8987
[email protected]
877-827-3222
Thomas A Hope, MD (PRINCIPAL_INVESTIGATOR)
Carissa Chu, MD (SUB_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California, San Francisco· San Francisco, CA

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