CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6 enrolled
Drug / intervention
Ga-68 PSMA-HBED-CC PETdrug
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/NCT03822845
NCT03822845Phase 3Completed
CompareCT.gov

Clinical Accuracy Assessment of 68Ga PSMA-HBED-CC PET in Patients With Biochemical Recurrence

Michael Graham PhD, MD·interventional·Posted Jan 30, 2019·Updated Apr 17, 2025

In Brief

A Phase 3 clinical trial evaluating Ga-68 PSMA-HBED-CC PET for Prostatic Neoplasms and Prostatic Neoplasms, Castration-Resistant. Completed, enrolled 6 participants across 1 site.

Detailed 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 match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker. To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms, Prostatic Neoplasms, Castration-Resistant
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 30, 2019
Enrollment StartMar 1, 2019
Primary CompletionMar 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.4 years ago

Interventions

Ga-68 PSMA-HBED-CC PETdrug

Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.