CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 22 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/NCT03388346
NCT03388346Phase 3Completed
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68Ga PSMA-HBED-CC in Intermediate to High-Risk Preprostatectomy Patients

Michael Graham PhD, MD·interventional·Posted Jan 2, 2018·Updated Feb 15, 2024

In Brief

A Phase 3 clinical trial evaluating Ga-68 PSMA-HBED-CC PET for Prostate Cancer and 3 related conditions. Completed, enrolled 22 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--
ConditionsProstate Cancer, Prostatic Neoplasm, Prostatic Neoplasms, Castration-Resistant, Prostatic Neoplasm of Uncertain Behavior
CountriesUnited States
CollaboratorsHolden Comprehensive Cancer Center, University of Iowa

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 2, 2018
Enrollment StartFeb 16, 2018
Primary CompletionJul 22, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.5 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.