Phase 2
N=51
The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04936334 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension — 86; 57 percentage — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 68Ga-PSMA-11 PET Scan (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Clinton Bahler
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension |
86; 57 | <0.05 sig |
| PRIMARY Specificity of PSMA-PET and MRI |
73; 77 | — |
| SECONDARY 1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET |
20 | — |
Summary
Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard).
Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4).
Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments.
Assess quality of life changes from preoperative baseline.
Eligibility Criteria
Inclusion Criteria
- 1. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with:
- > 3 cores of Gleason 3+4 or
- NCCN unfavorable intermediate risk or
- NCCN high-risk or
- NCCN very-high risk 3. Scheduled for standard of care MRI or has recently completed standard of care MRI (within 6 months).
Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI
Exclusion Criteria
- 1. 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 could affect prostate imaging).
- Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
Data sourced from ClinicalTrials.gov (NCT04936334). 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.