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.
Sensitivity of Ga-68 HBED-CC PSMA for Detection of Nodal MetastasesPrimary· 1 day
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true positive rate will be calculated with the corresponding 95% confidence interval.
Group
Value
95% CI
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
.59
Biochemical Recurrence (BCR) Population
.89
Specificity of Ga-68 HBED-CC PSMA for Detection of Nodal MetastasisPrimary· 1 day
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Group
Value
95% CI
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
.80
Biochemical Recurrence (BCR) Population
.31
Positive Predictive Value (PPV) of Ga-68 HBED-CC PSMA for Detection of Nodal MetastasisPrimary· 1 day
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Group
Value
95% CI
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
.67
Biochemical Recurrence (BCR) Population
.906
Negative Predictive Value (NPV) of Ga-68 HBED-CC PSMA for Detection of Nodal MetastasisPrimary· one month
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Group
Value
95% CI
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
.74
Biochemical Recurrence (BCR) Population
.24
Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR GroupSecondary· Up to 1 year
68Ga-labeled prostate-specific membrane antigen 11 (Ga68-PSMA-11) PET positivity rate by prostate-specific antigen (PSA) level is calculated by the number of positive reads divided by the total number of patients in the BCR Group per PSA value quintile (Detection rate (d) = total number of positive reads (t)/ total number of participants (N)).
<0.5 ng/dl
Group
Value
95% CI
Biochemical Recurrence (BCR) Population
.55
0.5 to < 1.0 ng/dl
Group
Value
95% CI
Biochemical Recurrence (BCR) Population
.62
1.0 to < 2.0 ng/dl
Group
Value
95% CI
Biochemical Recurrence (BCR) Population
.80
2.0 to < 5.0 ng/dl
Group
Value
95% CI
Biochemical Recurrence (BCR) Population
.88
>=5.0 ng/dl
Group
Value
95% CI
Biochemical Recurrence (BCR) Population
.96
Number of Patients in Biochemical Recurrence (BCR) Group Who Had a Reported Change in Medical ManagementSecondary· Up to 1 year
Change in participant medical management was determined based on the results of surveys given to each participant's treating physician. Results of the survey were categorized as a major change in participant's medical management, a minor change in participant's medical management, no change to participant's medical management, or change to participant's medical management is unknown. These categories were developed based on a predetermined categorization schema.
Major Change
Group
Value
95% CI
Biochemical Recurrence (BCR) Population
67
Minor Change
Group
Value
95% CI
Biochemical Recurrence (BCR) Population
8
Sponsor's own description
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Thomas Hope
Last refreshed: 22 December 2020
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/NCT02611882.