Phase 3
N=30
68Ga PSMA PET for Patients With Biochemical Recurrence of Prostate Cancer
Prostate Cancer · Prostatic Neoplasm · Prostatic Neoplasms, Castration-Resistant · Prostatic Cancer Recurrent · Prostatic Cancer Metastatic
Bottom Line
View on ClinicalTrials.gov: NCT03389451 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2024
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
- Jul 2019
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 Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Prostate Bed Lesions 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 Regional Pelvic Nodal Metastases 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 Extra-pelvic/Visceral Nodal Metastases on a Per Patient Basis |
— | — |
| SECONDARY Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Osseous Metastases on a Per Patient Basis |
1.0 | — |
Summary
This study investigates if a new prostate-specific membrane antigen (PSMA) drug 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
- Pathologically proven prostate adenocarcinoma
- Rising prostate-specific antigen (PSA )after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
- If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operative and confirmed persistent PSA > 0.2 ng/mL (AUA recommendation for biochemical recurrence)
- If post-radiation therapy, PSA that is ≥ 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence)
- 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 (KPS) ≥ 50 (ECOG/WHO of 0, 1, or 2)
- Ability to understand and willingness to provide informed consent
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 (NCT03389451). 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.