MedTrace Logo

Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

NCT03396874 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1435

Last updated 2023-11-03

Study results available
· View outcomes & findings →

Summary

This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body.

To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.

Conditions

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Prostate Cancer Metastatic
  • Prostate Cancer Recurrent

Interventions

DRUG

68Ga-PSMA

PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).

Sponsors & Collaborators

Principal Investigators

  • Morand R Piert, M.D. · University of Michigan

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2022-08-09
Completion
2022-08-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03396874 on ClinicalTrials.gov