Status:
COMPLETED
68Ga PSMA PET for Patients With Biochemical Recurrence of Prostate Cancer
Lead Sponsor:
Michael Graham PhD, MD
Collaborating Sponsors:
University of Iowa
Holden Comprehensive Cancer Center
Conditions:
Prostate Cancer
Prostatic Neoplasm
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief 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 t...
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
- 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
- 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 :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03389451
Start Date
February 16 2018
End Date
July 23 2019
Last Update
July 12 2024
Active Locations (1)
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1
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242