Status:
COMPLETED
68Ga-PSMA-11 PET in Patients With Prostate Cancer
Lead Sponsor:
University of Colorado, Denver
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18-100 years
Phase:
PHASE3
Brief Summary
Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.
Detailed Description
This is a prospective, Phase III, single-center, open-label to provide extended access in patients with biochemically recurrent prostate cancer. Approximately 100 patients are planned for enrollment i...
Eligibility Criteria
Inclusion
- Histopathologically proven prostate adenocarcinoma
- Age ≥ 18 years
- Patients already diagnosed with prostate cancer: Primary Staging: intermediate and high-risk patients per NCCN guidelines
- Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy):
- a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equal to 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a second determination of a PSA level of \>0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenix consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion
- Unable to lie flat, still or tolerate a PET/CT scan, or any other condition that would preclude PET/CT imaging.
- Patients with any medical condition or circumstance that the investigator believes may compromise the data collection or lead to a failure to fulfil the study requirements.
- Patients with known hypersensitivity to the active substance or to any of the excipients of the investigational product.
Key Trial Info
Start Date :
September 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2022
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT05197257
Start Date
September 29 2021
End Date
April 14 2022
Last Update
November 13 2023
Active Locations (2)
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1
Colorado Research Center
Aurora, Colorado, United States, 80045
2
UCHealth-Metro Denver
Denver, Colorado, United States, 80217-3364