18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Diagnostic Accuracy of PSMA PETPrimary· 60 days
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.
Sensitivity for EPE (%)
Group
Value
95% CI
Prostate Cancer Being Treated With Radical Prostatectomy
100
Specificity for EPE (%)
Group
Value
95% CI
Prostate Cancer Being Treated With Radical Prostatectomy
74
Impact of PSMA PET-CT on Treatment Plan for Surgery or BiopsySecondary· 60 days
Does the PSMA-PET change the treatment or biopsy decision. The surgeon will look at imaging prior to a procedure (prostatectomy, HIFU, or biopsy) to see if it informs the procedure steps. Does the imaging add new information about the cancer that could alter the biopsy or treatment? PSMA-PET scans were obtained in 3 different contexts as listed below (prior to prostate removal, screening for cancer or on active surveillance, and prior to focal therapy). We calculate the percentage of cases that had the treatment or followup plan altered by the investigational imaging agent.
For example, if th
Group
Value
95% CI
Prostate Cancer Being Treated With Radical Prostatectomy
10
Screening for Prostate Cancer or on Active Surveillance
8
Prostate Cancer Being Treated With Focal Therapy
5
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 8 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03429244.