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NCT06105918 · ClinicalTrials.gov registry record · Phase 1
Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer
A Phase 1 study of Prostate Adenocarcinoma and Biochemically Recurrent Prostate Carcinoma, sponsored by Emory University.
- Active
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT06105918: Active Phase 1 study of Prostate Adenocarcinoma and Biochemically Recurrent Prostate Carcinoma, sponsored by Emory University.
NCT06105918 is a Phase 1 study of Prostate Adenocarcinoma and Biochemically Recurrent Prostate Carcinoma that is active but no longer recruiting, run by Emory University. The registered enrollment target is 6 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06105918, a Phase 1 study of Prostate Adenocarcinoma and Biochemically Recurrent Prostate Carcinoma, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects and best dose of radioligand therapy (lutetium Lu 177 PSMA-10.1 \[177Lu-rhPSMA-10.1\]) after prostate specific membrane antigen (PSMA) positron emission tomography (PET)-guided external beam radiotherapy in treating post-prostatectomy patients with prostate cancer that has come back after a period of improvement (recurrent). In this study, radioligand therapy is a radioactive drug called 177Lu-rhPSMA-10.1. It works by binding to PSMA-expressing prostate tumor cells and delivering the radioactive portion of the drug directly to the tumor cells while not harming normal cells. Radiation therapy such as external beam radiotherapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radioligand therapy with PSMA PET-guided external beam radiotherapy may kill more tumor cells in post-prostatectomy patients with biochemically recurrent prostate cancer.
Primary Outcome
Will be summarized descriptively using frequencies and percentages of all captured toxicities by grade and relevance.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- RADIATION External Beam Radiation Therapy
- OTHER Flotufolastat F-18
- DRUG Lutetium Lu 177 PSMA-10.1
Study Locations (1)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-11-29 |
| Est. Completion | 2029-04-01 |
| Phase | Phase 1 |
What the registry record for NCT06105918 still lists
NCT06105918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06105918 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06105918 about?
NCT06105918 is a clinical study titled "Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer". This phase I trial tests the safety, side effects and best dose of radioligand therapy (lutetium Lu 177 PSMA-10.1 \[177Lu-rhPSMA-10.1\]) after prostate specific membrane antigen (PSMA) positron emission tomography (PET)-guided external beam radiotherapy in treating post-prostatectomy patients with p...
What is the current status of trial NCT06105918?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2023-11-29. Estimated completion is 2029-04-01.
What conditions does trial NCT06105918 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Biochemically Recurrent Prostate Carcinoma.
What interventions are being tested in trial NCT06105918?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), External Beam Radiation Therapy (RADIATION), Flotufolastat F-18 (OTHER), Lutetium Lu 177 PSMA-10.1 (DRUG).
Who is sponsoring clinical trial NCT06105918?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06105918 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06105918's enrollment target sits among peer trials
6 99th of 99 higher than 1 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma 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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