Phase 3 N=39 Diagnostic

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

Prostate Cancer · Prostate Adenocarcinoma

Bottom Line

View on ClinicalTrials.gov: NCT05197257 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Number of Participants With Adverse Events — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ga-PSMA-11 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: University of Colorado, Denver
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	—	—
SECONDARY Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities.	12; 1; 22; 21; 7	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05197257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.