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NCT07150715 · ClinicalTrials.gov registry record · Phase 2
Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma
A Phase 2 study of Recurrent Prostate Adenocarcinoma and Oligometastatic Prostate Adenocarcinoma, sponsored by Jonsson Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
- 1
- Study location
NCT07150715: Recruiting Phase 2 study of Recurrent Prostate Adenocarcinoma and Oligometastatic Prostate Adenocarcinoma, sponsored by Jonsson Comprehensive Cancer Center.
NCT07150715 is a Phase 2 study of Recurrent Prostate Adenocarcinoma and Oligometastatic Prostate Adenocarcinoma that is actively recruiting participants, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 107 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07150715, a Phase 2 study of Recurrent Prostate Adenocarcinoma and Oligometastatic Prostate Adenocarcinoma, is actively recruiting participants, sponsored by Jonsson Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial compares the use of 225Ac-PSMA-617 to 177Lu-PSMA-617, along with stereotactic body radiotherapy for the treatment of prostate cancer that has come back after a period of improvement (recurrent) and that has spread from where it first started (primary site) to multiple other places in the body (oligometastatic). 225Ac-PSMA-617 and 177Lu-PSMA-617 are radioactive drugs. They bind to a protein called a PSMA receptor, which is found on some prostate tumor cells. 225Ac-PSMA-617 or 177Lu-PSMA-617 builds up in these cells and gives off either alpha or beta radiation that may kill them. It is a type of radioconjugate and a type of PSMA analog. Stereotactic body radiation therapy (SBRT) is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving 225Ac-PSMA-617 or 177Lu-PSMA-617 and metastasis directed stereotactic body radiotherapy may be effective in treating patients with recurrent, oligometastatic prostate cancer.
Primary Outcome
A progression event will be based on prostate specific membrane antigen positron emission tomography/ computed tomography findings triggered either by a prostate specific antigen rise or at the timepoint defined by 24 months measured from the final radionuclide infusion (i.e., second infusion of 177Lu-PSMA-617 and first infusion of 225Ac-PSMA-617). The Kaplan-Meier (KM) method will be used to summarize PFS and log-rank test will be used to compare PFS between the two arms.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Actinium Ac 225 Vipivotide Tetraxetan
- OTHER Gallium Ga 68 Gozetotide
- DRUG Lutetium Lu 177 Vipivotide Tetraxetan
- PROCEDURE PSMA PET-CT Scan
Study Locations (1)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2025-12-12 |
| Est. Completion | 2031-10-31 |
| Phase | Phase 2 |
What NCT07150715 shows while recruiting
NCT07150715 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 2 conditions, with Recurrent Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07150715 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07150715 about?
NCT07150715 is a clinical study titled "Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma". This phase II trial compares the use of 225Ac-PSMA-617 to 177Lu-PSMA-617, along with stereotactic body radiotherapy for the treatment of prostate cancer that has come back after a period of improvement (recurrent) and that has spread from where it first started (primary site) to multiple other place...
What is the current status of trial NCT07150715?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2025-12-12. Estimated completion is 2031-10-31.
What conditions does trial NCT07150715 study?
This clinical trial studies the following conditions: Recurrent Prostate Adenocarcinoma, Oligometastatic Prostate Adenocarcinoma.
What interventions are being tested in trial NCT07150715?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Actinium Ac 225 Vipivotide Tetraxetan (DRUG), Gallium Ga 68 Gozetotide (OTHER), Lutetium Lu 177 Vipivotide Tetraxetan (DRUG), PSMA PET-CT Scan (PROCEDURE).
Who is sponsoring clinical trial NCT07150715?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07150715 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 NCT07150715's enrollment target sits among peer trials
107 646th of 2000 higher than 1,354 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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