Phase 2
N=20
The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
Prostate Cancer · Prostate Cancer Metastatic
Bottom Line
View on ClinicalTrials.gov: NCT04179968 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging — 24 lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 68Ga PSMA-11 injection (Drug); Positron Emission Tomography/Computed Tomography (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Dana Mathews
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging |
24 | — |
| PRIMARY Number of Primary Prostate Lesions Detected by mpMRI |
37 | — |
| SECONDARY Number of Sites of Metastatic Prostate Lesions Detected on 68Ga-PSMA-11 PET/CT |
7 | — |
| SECONDARY Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI) |
5 | — |
Summary
To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to increase diagnostic accuracy in localizing primary and metastatic lesions in patients with suspected prostate cancer and elevated Prostate Imaging Reporting and Data System (PI-RADS) scores and Prostate-Specific Antigen (PSA).
Eligibility Criteria
Inclusion Criteria
- Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician
- Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4
- In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.
- Patients must be scheduled for biopsy or radical prostatectomy
- Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study
- Patients must be medically stable as judged by the patient's physician
- Patients must be able to lie still for a total of 60 minutes for the PET/CT scans
- Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria
- Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study
- Patients who have had a prior biopsy for prostate cancer cannot participate in the study
- Patients who have been treated for cancers other than skin cancers
- Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
- Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (>200 kilograms or 440 pounds)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI
- Prior transurethral resection of the prostate (TURP)/benign prostatic hyperplasia (BPH) procedures, including steam/laser therapies
Data sourced from ClinicalTrials.gov (NCT04179968). 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.