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Summary

Eligibility
for males ages 18 years and up
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator
Thomas A Hope

Description

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.

Official Title

Evaluation of Gallium-68 HBED-CC-PSMA Imaging in Prostate Cancer Patients

Details

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.

Keywords

Prostate Cancer N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid Edetic Acid

Eligibility

You can join if…

Open to males ages 18 years and up

  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.

You CAN'T join if...

  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.).

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Thomas Hope
ID
NCT02611882
Phase
Phase 1/2
Lead Scientist
Thomas A Hope
Study Type
Interventional
Last Updated
September 12, 2016
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