Status:
COMPLETED
Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer
Lead Sponsor:
Michael Graham PhD, MD
Conditions:
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ma...
Detailed Description
This study evaluates PSMA-HBED-CC labelled with Gallium-68, abbreviated 68Ga PSMA. This is a radiotracer that attaches to receptors in the membrane of prostate cancer cells. The 68Ga PSMA is identifie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03822845
Start Date
March 1 2019
End Date
March 30 2021
Last Update
April 17 2025
Active Locations (1)
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1
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242