Phase 3
N=485
Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03803475 ↗Enrolled (actual)
485
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group — 0.38; 0.45; 0.76; 0.73 proportion
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ga-68 labeled PSMA-11 (Drug); Positron emission tomography-computed tomography (PET/CT) (Device); Positron emission tomography-magnetic resonance imaging (PET/MRI) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Thomas Hope
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group |
0.38; 0.45; 0.76; 0.73; 0.82; 0.62 | — |
| PRIMARY Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group |
0.14; 0.09; 0.18; 0.37; 0.50; 0.76 | — |
| PRIMARY Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group |
0.10; 0.27; 0.51; 0.24; 0.34; 0.37 | — |
| PRIMARY Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group |
0.10; 0.09; 0.10; 0.18; 0.30; 0.21 | — |
| PRIMARY Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group |
0.03; 0.09; 0.18; 0.22; 0.25; 0.26 | — |
Summary
The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.
Eligibility Criteria
Inclusion Criteria
- Male, age >= 18.
- Histopathologically proven prostate adenocarcinoma.
- Concern for metastatic disease in one of the following settings:
- Initial staging with intermediate to high risk prostate cancer.
- Biochemical recurrence after initial therapy.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
- Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
Data sourced from ClinicalTrials.gov (NCT03803475). 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.