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NCT07054346 · ClinicalTrials.gov registry record · Phase 1
Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617
A Phase 1 study of Prostate Cancer and Localized Prostate Carcinoma, sponsored by Thomas Hope.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT07054346: Recruiting Phase 1 study of Prostate Cancer and Localized Prostate Carcinoma, sponsored by Thomas Hope.
NCT07054346 is a Phase 1 study of Prostate Cancer and Localized Prostate Carcinoma that is actively recruiting participants, run by Thomas Hope. The registered enrollment target is 45 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07054346, a Phase 1 study of Prostate Cancer and Localized Prostate Carcinoma, is actively recruiting participants, sponsored by Thomas Hope.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The mean tumor absorbed dose on post-treatment SPECT imaging within 7 days of the first radioligand treatment (RLT) will be obtained by using MIM Software to measure absorbed dose and researchers will manually segment activity in the dominant prostate tumor while carefully excluding any activity within the bladder using a threshold of 5 Gray. Using this segmented volume, the mean dose within the tumor in Gray for each participant and standard deviation will be calculated and reported descriptive
Conditions Studied
Interventions
- DRUG 177 Lutetium Prostate-Specific Membrane Antigen 617
- DRUG Actinium-225 Prostate-Specific Membrane Antigen 617
- PROCEDURE Non-investigational, Prostatectomy
- PROCEDURE Prostate Tissue Collection
- PROCEDURE Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2025-07-08 |
| Est. Completion | 2028-04-30 |
| Phase | Phase 1 |
What NCT07054346 shows while recruiting
NCT07054346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which 177 Lutetium Prostate-Specific Membrane Antigen 617 is the first listed.
NCT07054346 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07054346 about?
NCT07054346 is a clinical study titled "Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617". 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 act...
What is the current status of trial NCT07054346?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2025-07-08. Estimated completion is 2028-04-30.
What conditions does trial NCT07054346 study?
This clinical trial studies the following conditions: Prostate Cancer, Localized Prostate Carcinoma, Prostate Cancer (Diagnosis), High-risk Prostate Cancer, Very High Risk Prostate Carcinoma.
What interventions are being tested in trial NCT07054346?
The interventions under investigation include: 177 Lutetium Prostate-Specific Membrane Antigen 617 (DRUG), Actinium-225 Prostate-Specific Membrane Antigen 617 (DRUG), Non-investigational, Prostatectomy (PROCEDURE), Prostate Tissue Collection (PROCEDURE), Single-photon emission computed tomography (SPECT)/Computerized tomography (CT) (PROCEDURE).
Who is sponsoring clinical trial NCT07054346?
This trial is sponsored by Thomas Hope, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07054346 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07054346's enrollment target sits among peer trials
45 506th of 735 higher than 223 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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