21 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.
Number of Subjects With Pathologic Lesions Detected by PSMA PET and PET/CT Compared to MP MRIPrimary· At each visit, immediately after administration of the study drug, approximately 2-3 hours; with up to two visits within 2 years or less
A scan was considered positive if the clinical interpretation was suspicious based on the clinical judgement of the reader.
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
63
MRI Scan
37
Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region Stratified by PSA LevelPrimary· At each visit, immediately after administration of the study drug, approximately 2-3 hours; with up to two visits within 2 years or less
Patients were divided into subgroups based on their PSA levels and primary treatment modality. The primary treatment modality subgroups were post radical prostatectomy, post radiation therapy, and post radical prostatectomy and radiation therapy. 109 subjects out of 273 enrolled have data reported. Multiple patients sought care elsewhere and a small number of subjects had 2-year follow-up. This lead to a smaller analysis.
Total Number of Lesions
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
92
MRI Scan
47
PSA Levels 0 to < 0.2 ng/mL
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
10
MRI Scan
0
PSA Levels 0.2 to < 0.5 ng/mL
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
22
MRI Scan
19
PSA Levels 0.5 to 2.0 ng/mL
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
25
MRI Scan
10
PET/MRI: PSA Levels > 2.0 ng/mL
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
35
MRI Scan
18
Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical RegionSecondary· At each visit, immediately after administration of the study drug, approximately 2-3 hours; with up to two visits within 2 years or less
True positive rates for detecting lesions between PSMA PET/MRI and MP MRI in various anatomical locations were compared, including prostate/prostatic bed, N1 lymph nodes, N2 lymph nodes, and osseous lesions. Other anatomical sites are other than bone, node, and prostate.
Total Number of Lesions
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
92
MRI Scan
47
N1 lymph nodes
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
34
MRI Scan
11
N2 lymph nodes
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
20
MRI Scan
7
Osseous
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
24
MRI Scan
14
Prostate
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
3
MRI Scan
7
Prostatic Bed
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
8
MRI Scan
7
Other Anatomical Sites
Group
Value
95% CI
PSMA PET/MRI and PET/CT Scan
3
MRI Scan
1
Sponsor's own description
This is a study primarily comparing Magnetic Resonance Imaging (MRI) alone to Positron Emission Tomography (PET)/MRI using an experimental tracer, 68Ga-PSMA-HBED-CC, among men with prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this comparison will demonstrate that PET using the tracer, 68Ga-PSMA-HBED-CC, is more sensitive than MRI alone. Potential subjects who cannot undergo MRI may undergo PET/CT instead.
Publications & conference data
1 peer-reviewed publication 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 Weill Medical College of Cornell University
Last refreshed: 13 March 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/NCT03439033.