Phase 2
N=36
PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03429244 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Diagnostic Accuracy of PSMA PET — 100; 74 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 68Ga-PSMA-11 PET-MRI (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Indiana University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Accuracy of PSMA PET |
100; 74 | — |
| SECONDARY Impact of PSMA PET-CT on Treatment Plan for Surgery or Biopsy |
10; 8; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years of age
- Must provide written informed consent
- Presence of low or intermediate risk prostate cancer or at risk of having intermediate risk cancer
a. Intermediate risk prostate cancer: i. Grade group 2 = 3 + 4, or ii. Grade group 3 = 4 + 3 b. At Risk of intermediate risk prostate cancer: i. 4K score ≥ 20%, or ii. Select MDx ≥ 20%, or iii. PSA Density ≥ 0.15 iv. Grade group 1= 3+3 (iv. Note: Where multiple cancer lesions are present on biopsy, it is allowable to have Gleason 8 or 9 cancer lesions if they are in addition to the intermediate risk cancer as described above.)
- Scheduled for MRI or has recently completed SOC MRI (within 6 months) for further biopsy, or surgical removal, or focal therapy.
- Willing and able to lie still for approximately 50 minutes in an enclosed space for the CT.
Exclusion Criteria
- Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
- Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed).
- Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
Data sourced from ClinicalTrials.gov (NCT03429244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.