CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 39 enrolled
Drug / intervention
Ga-PSMA-11drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05197257
NCT05197257Phase 3Completed
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68Ga-PSMA-11 PET in Patients With Prostate Cancer

University of Colorado, Denver·interventional·Posted Jan 19, 2022·Updated Nov 13, 2023

In Brief

A Phase 3 clinical trial evaluating Ga-PSMA-11 for Prostate Cancer and Prostate Adenocarcinoma. Completed, enrolled 39 participants across 2 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, Prostate Adenocarcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJan 19, 2022
Enrollment StartSep 29, 2021
Primary CompletionApr 14, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.5 years ago

Interventions

Ga-PSMA-11drug

The PSMA Sterile Cold Kit, is a kit comprising all needed materials (lyophilized PSMA for PSMA reconstitution, elution vial for Ga and ancillary materials for transfer between vials) to perform a room-temperature radiolabelling of PSMA-11 with Ga. Ga is not part of the kit and should be provided in the form gallium chloride solution following the requirements of the relevant local regulations. PSMA-11 radiolabelled with Ga is administered in patients with prostate cancer recurrence after radical treatment.