Status:
COMPLETED
68Ga PSMA in Preprostatectomy Patients
Lead Sponsor:
Michael Graham PhD, MD
Collaborating Sponsors:
Holden Comprehensive Cancer Center
University of Iowa
Conditions:
Prostate Cancer
Prostatic Neoplasm
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
- 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
- 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
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03388346
Start Date
February 16 2018
End Date
July 22 2021
Last Update
February 15 2024
Active Locations (1)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242