Phase 3
N=6
Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer
Prostatic Neoplasms · Prostatic Neoplasms, Castration-Resistant
Bottom Line
View on ClinicalTrials.gov: NCT03822845 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection on a Per Patient Basis — 1.0 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ga-68 PSMA-HBED-CC PET (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Michael Graham PhD, MD
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection on a Per Patient Basis |
1.0 | — |
| SECONDARY Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Tumor Location on a Per Patient Basis |
1.0 | — |
| SECONDARY Sensitivity of Ga 68-labeled PSMA-11 (PET/CT) for Detecting Tumor Location, Confirming With Histopathology, on a Per-subject Basis. |
— | — |
| SECONDARY Determine Detection Rates on a Per-subject Basis of 68Ga PSMA-HBED-CC PET/CT When Stratified by PSA Value |
2; 0; 0; 0; 0 | — |
Summary
This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker.
To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.
Eligibility Criteria
Inclusion Criteria
- Ability to understand and willingness to provide informed consent.
- Pathologically proven prostate adenocarcinoma.
- Rising PSA after definitive therapy with a prostatectomy or radiation therapy (external beam radiation therapy or brachytherapy).
- If post-radical prostatectomy, a PSA level of > 0.2 ng/mL measured more than 6 weeks post-operatively with a second confirmatory persistent PSA > 0.2 ng/mL.
- If post-radiation therapy, a PSA level that is equal to, or greater than, a 2 mg/mL rise above the lowest PSA value ('nadir').
- A PSA level result within the last 2 months meeting criteria above.
- Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations).
- No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion).
- Karnofsky performance status greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months.
Exclusion Criteria
- Cannot receive furosemide.
- History of Stevens-Johnson syndrome.
- History or diagnosis of Paget's disease.
- Malignancy other than current disease under study.
- Allergy to sulfa or sulfa-containing medications.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Data sourced from ClinicalTrials.gov (NCT03822845). 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.