Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment ga-68 labeled hbed-cc psma pet imaging
Phase phase 1/phase 2
Sponsor Thomas Hope
Start date September 2015
End date December 2019
Trial size 225 participants
Trial identifier NCT02611882, 15-17570

Summary

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
ga-68 labeled hbed-cc psma pet imaging Ga-68 labeled DKFZ-PSMA-11
Patients will be imaged using Ga-68-HBED-CC-PSMA PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

Primary Outcomes

Measure
The sensitivity of Ga-68 HBED-CC PSMA for the detection of nodal metastasis in high-risk pre-prostatectomy patients.
time frame: one month
The specificity of Ga-68 HBED-CC PSMA for the detection of nodal metastasis in high-risk pre-prostatectomy patients.
time frame: one month
The sensitivity of Ga-68 HBED-CC PSMA for the detection of metastatic disease in patients with biochemical recurrence after prostatectomy or radiation therapy.
time frame: one month
Number of lesions that Gallium-68 labeled HBED-CC PSMA delineates in comparison to conventional imaging in castrate resistant prostate cancer patients.
time frame: one month

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: 1. Known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below: - Treatment naïve patients with one of the following risk factors: CAPRA (Cancer of the Prostate Risk Assessment) score ≥ 5, PSA ≥ 15 ng/mL and/or Gleason score ≥ 4+4. - Patients with biochemical recurrence after prostatectomy or radiation therapy with a PSA doubling time less than 12 months. i. These patients may have received androgen deprivation therapy prior to imaging. - Patients with castrate resistant prostate cancer with progressive disease as defined by PCWG2 criteria (27). i. Patients with castrate resistant prostate cancer can be either on treatment or off treatment 2. Age > 18. 3. Karnofsky performance status of > 50 (or ECOG/WHO equivalent). 4. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI. 2. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.). 3. Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).

Additional Information

Official title Evaluation of Gallium-68 HBED-CC-PSMA Imaging in Prostate Cancer Patients
Principal investigator Thomas A Hope
Description Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled HBED-CC PSMA in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the HBED-CC PSMA compound, so that this agent will become available for clinical imaging in prostate cancer patients. This compound has been shown to be superior to choline based PET agents for the staging of prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented and therefore no company or private entity will make the investment required to bring HBED-CC PSMA to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval. This study focuses on three patients populations that are imaged. In the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis. In the biochemical recurrence population, the primary objective is to determine the sensitivity of recurrence location. In the castrate resistant prostate cancer population the primary objective is to determine if PSMA PET detects more metastatic lesions than conventional imaging.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.