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NCT03429244 · ClinicalTrials.gov registry record · Phase 2
PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 4
- Study locations
NCT03429244: Completed Phase 2 study of Prostate Cancer, sponsored by Indiana University.
NCT03429244 is a Phase 2 study of Prostate Cancer that has completed, run by Indiana University. The registered enrollment target is 36 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03429244, a Phase 2 study of Prostate Cancer, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 4
- Study locations
Study Summary
The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease. A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system (Siemens Biograph VisionPET-CT), will improve accuracy during biopsy and staging. We propose detailed intra-lesion whole-mount pathologic analysis as the gold standard for critically assessing PSMA PET accuracy in patients undergoing surgery, and blinded PSMA PET-CT comparison with standard multi-parametric MRI (mpMRI) for patients having biopsy on active surveillance. This intensive testing of the accuracy and value of PSMA-based tracers requires our unique collaboration of surgeons, radiologists, pathologists, and imaging scientists with decades of experience and innovation.
Primary Outcome
Sensitivity and specificity for EPE using whole-mount analysis or biopsy pathology. EPE is extra-prostatic extension which means the cancer extends beyond the boundary of the prostate into adjacent muscle or fatty tissue.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST 68Ga-PSMA-11 PET-MRI
Study Locations (4)
Indiana
- Indiana University Health North Hospital - Carmel
- Indiana University Health Hospital - Indianapolis
- Indiana University Health Methodist Hospital - Indianapolis
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2022-05-01 |
| Phase | Phase 2 |
What the finished NCT03429244 record still lists
NCT03429244 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which 68Ga-PSMA-11 PET-MRI is the first listed.
NCT03429244 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT03429244 about?
NCT03429244 is a clinical study titled "PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer". The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease. A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advance...
What is the current status of trial NCT03429244?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2019-04-15. Estimated completion is 2022-05-01.
What conditions does trial NCT03429244 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT03429244?
The interventions under investigation include: 68Ga-PSMA-11 PET-MRI (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03429244?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03429244 being conducted?
This trial has 4 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03429244's enrollment target sits among peer trials
36 544th of 735 higher than 185 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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