Phase 3
N=385
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02918357 ↗Enrolled (actual)
385
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation — 0.90 percentage of times value is true
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ga-68 labeled PSMA-11 PET (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of California, San Francisco
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation |
0.90 | — |
| PRIMARY Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation |
0.91 | — |
| SECONDARY PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up |
0.81 | — |
| SECONDARY PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up |
0.92 | — |
| SECONDARY Sensitivity on a Per-patient Basis |
0.92 | — |
| SECONDARY Sensitivity on a Per-region Basis |
0.90 | — |
| SECONDARY Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value |
40; 51; 87; 83; 96 | — |
| SECONDARY Inter-reader Agreement Per-region |
0.65; 0.73; 0.70; 0.78 | — |
| SECONDARY Percentage of Participants With Change in Clinical Management |
72 | — |
| SECONDARY Safety Assessment - Heart Rate |
67.8; 66.9; 0.9 | — |
| SECONDARY Safety Assessment - Blood Pressure |
137.8; 137.0; 1.0; 80.3; 81.1; 0.6 | — |
Summary
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
Eligibility Criteria
Inclusion Criteria
- Histopathological proven prostate adenocarcinoma.
- Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
- PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
- Confirmatory persistent PSA greater than 0.2 ng/mL
- Post-radiation therapy -ASTRO-Phoenix consensus definition
- Nadir + greater than or equal to 2 ng/mL rise in PSA
- Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
- Age > 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
- Investigational therapy for prostate cancer.
- Unable to lie flat, still or tolerate a PET scan.
- Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
Data sourced from ClinicalTrials.gov (NCT02918357). 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.