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NCT07682649 · ClinicalTrials.gov registry record · Phase 1
Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer
A Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT07682649: Clinical Trial Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT07682649 is a Phase 1 study that has not yet begun recruiting, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07682649, a Phase 1 study, has not yet begun recruiting, sponsored by University of Michigan Rogel Cancer Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. It binds to a protein called prostate-specific membrane antigen (PSMA), which is found on prostate cancer tumor cells. Lu-177-PSMA-617 gives off radiation that may kill these tumor cells. It is a type of radioconjugate. Lu-177-PSMA-617 is currently used in a series of 6 intravenous infusions of the standard dosage, each separated by 6 weeks from the previous infusion. Investigators have observed that the first therapy administration (cycle 1) delivers better radiation treatment to the cancer than each of the following 5 infusions. Giving an increased dosage of Lu-177-PSMA-617 in treatment cycle 1 may have a better effect on metastatic castration-resistant prostate cancer than the standard dosage. The study does not change the total cumulative activity from what is used in the standard dosage treatment but gives an increased dosage in cycle 1 and reduces the total number of cycles.
Primary Outcome
The rate of drug-related adverse events that meet protocol-specified dose-limiting criteria and occur during the time period from administration of cycle 1 dosage up to administration of cycle 2 dosage.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- OTHER Gallium Ga 68 Gozetotide
- DRUG Lutetium Lu 177 Vipivotide Tetraxetan
- DEVICE Positron Emission Tomography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2031-08 |
| Phase | Phase 1 |
What is known before NCT07682649 opens enrollment
NCT07682649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07682649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07682649 about?
NCT07682649 is a clinical study titled "Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer". This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started...
What is the current status of trial NCT07682649?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2026-08-01. Estimated completion is 2031-08.
What interventions are being tested in trial NCT07682649?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Gallium Ga 68 Gozetotide (OTHER), Lutetium Lu 177 Vipivotide Tetraxetan (DRUG), Positron Emission Tomography (DEVICE).
Who is sponsoring clinical trial NCT07682649?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07682649's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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