Phase 3
N=22
68Ga PSMA in Preprostatectomy Patients
Prostate Cancer · Prostatic Neoplasm · Prostatic Neoplasms, Castration-Resistant · Prostatic Neoplasm of Uncertain Behavior
Bottom Line
View on ClinicalTrials.gov: NCT03388346 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Sensitivity 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 — .5 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 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 of Regional Pelvic Nodal Metastases on a Per Patient Basis |
.5 | — |
| PRIMARY Specificity 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 |
.89 | — |
| PRIMARY 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 |
.33 | — |
| PRIMARY Negative Predictive Value (NPV) 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 |
.94 | — |
| SECONDARY Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis |
— | — |
| SECONDARY Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis |
0.71 | — |
| SECONDARY Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis |
— | — |
| SECONDARY Negative Predictive Value (NPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis |
1.0 | — |
| SECONDARY Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis |
— | — |
| SECONDARY Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral 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 Visceral Metastases on a Per Patient Basis |
— | — |
| SECONDARY Negative Predictive Value (NPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis |
1.0 | — |
| SECONDARY Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Osseous Metastases on a Per Patient Basis |
— | — |
| SECONDARY Specificity 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 | — |
| 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 |
— | — |
| SECONDARY Negative Predictive Value (NPV) 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 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
- Biopsy-proven prostate adenocarcinoma
- Intermediate to high-risk disease, defined as one of the following factors: PSA > 10, T2b or greater, or a Gleason score of 7 or greater
- A PSA level resulted within the past 2 months
- Planned prostatectomy with lymph node dissection
- Karnofsky performance status (KPS) greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months
- Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu)
- Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations
- Ability to understand and the willingness to provide informed consent.
Exclusion Criteria
- Cannot receive furosemide
- Allergy to sulfa or sulfa-containing medications
- History of Stevens-Johnson syndrome
- Known Paget's disease
- 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 (NCT03388346). 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.