68Ga-PSMA-11 PET in Patients With Prostate Cancer

Completed · Phase 3

Conditions studied: Prostate Cancer, Prostate Adenocarcinoma

In brief

Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

Key facts

Study ID: NCT05197257
Run by: University of Colorado, Denver
People needed: 39
Starts: 2021-09-29
Expected to finish: 2022-04-14
Last updated by the study team: 2023-11-13

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Colorado Research Center — Aurora, Colorado, United States
UCHealth-Metro Denver — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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