Recruiting
Phase 1

225Ac-PSMA vs. 177Lu-PSMA

Sponsor:

Thomas Hope

Code:

NCT07054346

Conditions

Prostate Cancer

Prostate Cancer (Diagnosis)

High-risk Prostate Cancer

Localized Prostate Carcinoma

Very High Risk Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

177 Lutetium Prostate-Specific Membrane Antigen 617

Actinium-225 Prostate-Specific Membrane Antigen 617

Non-investigational, Prostatectomy

Prostate Tissue Collection

Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)

Study Details

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.

Conditions

Prostate Cancer

Prostate Cancer (Diagnosis)

High-risk Prostate Cancer

Localized Prostate Carcinoma

Very High Risk Prostate Carcinoma

Study ID

NCT07054346

Start date

Jul 8, 2025

Status verified date

Aug, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥18 years.
2. Histologically confirmed prostate adenocarcinoma.
3. High-risk disease as defined as meeting 1 or more of the 3 following criteria:

1. Gleason score of 4+4 disease or higher, Or Gleason 4+3 with large cribriform component (defined as >0.25 mm in short diameter)
2. Pelvic nodal metastases on PSMA PET.
3. Extracapsular extension or seminal vesicle invasion on MRI or PSMA PET.
4. No evidence of distant metastatic disease as determined by PSMA PET. Nodal disease at or 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).

\*Note: this applies to treatment cohorts only; there are no SUV requirements for tissue-only cohorts (Control Group).
6. Target tumor in the prostate measuring greater than 1.0 cm on MRI.
7. Willing to undergo prostatectomy with or without lymph node dissection, and candidate for prostatectomy as determined by urologic oncology.
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.

  • Note: this applies to treatment cohorts only; there are no requirements for tissue-only cohorts (Control Group)
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. 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.
2. 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.
3. Concurrent and 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.
4. 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.
5. 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.
6. Prior external beam radiation therapy (EBRT) to the prostate or prostate bed.
7. Dry mouth that impacts the eating of food (i.e., requiring fluids prior to eating)

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.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

Primary outcome measure

  • Mean of tumor absorbed dose (Cohorts 1 and 2) [ Time Frame: 1 week ]
  • Rate of Cluster of differentiation 3 positive (CD3+) T cell infiltration [ Time Frame: 1 day, at time of prostatectomy ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Thomas A Hope, MD

More Information

Sponsor

Thomas Hope

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Radioligand Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Thomas Hope on 2026-08-28.