CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 5 enrolled
Drug / intervention
Gallium Ga-labeled PSMA-11 +3 moredrug
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/NCT04976257
NCT04976257Early Ph 1Completed
CompareCT.gov

Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA Radioligand Infusions in Treatment-Naïve Prostate Cancer Patients

Ryan Kohlbrenner, MD·interventional·Posted Jul 26, 2021·Updated Apr 7, 2023

In Brief

A Early Phase 1 clinical trial evaluating Angiogram, Catheterization, and 2 other interventions for Prostate Adenocarcinoma and 9 related conditions. Completed, enrolled 5 participants across 1 site.

Detailed Summary

Prostate-specific membrane antigen (PSMA) agents have shown promise in detecting and treating prostate cancer. Gallium-68-labeled PSMA-11 (68Ga-PSMA-11) is a radioactive agent that binds to prostate cancer cells and can be imaged using positron emission tomography (PET) scanners that detect radioactivity in the body. This early phase I study will use PET to determine if delivering 68Ga-PSMA-11 directly into the prostatic artery (intra-arterial (IA) administration) results in greater uptake in the prostate than delivering 68Ga-PSMA-11 into a vein in the arm (intravenous (IV) administration).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Adenocarcinoma, Prostate Carcinoma, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
CountriesUnited States
CollaboratorsRadiological Society of North America

Timeline

Early Ph 1CompletedFinished
20222023202420252026
First PostedJul 26, 2021
Enrollment StartOct 13, 2021
Primary CompletionMar 22, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.9 years ago

Interventions

Angiogramprocedure

Undergo angiogram

Catheterizationprocedure

Undergo prostatic arterial catheterization

Gallium Ga-labeled PSMA-11drug

Given IV and IA

Positron Emission Tomographyprocedure

Undergo PET scan