We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02611882
First Posted: November 23, 2015
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Drug: Ga-68 labeled HBED-CC PSMA PET imaging Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Gallium-68 HBED-CC-PSMA Imaging in Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Thomas Hope, University of California, San Francisco:

Primary Outcome Measures:
  • The sensitivity of Ga-68 HBED-CC PSMA for the detection of nodal metastasis in high-risk pre-prostatectomy patients. [ Time Frame: one month ]
    Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true positive rate and the true negative rate will be calculated with the corresponding 95% confidence interval.

  • The specificity of Ga-68 HBED-CC PSMA for the detection of nodal metastasis in high-risk pre-prostatectomy patients. [ Time Frame: one month ]
    Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true positive rate and the true negative rate will be calculated with the corresponding 95% confidence interval.

  • 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 ]
    it will be assumed that all patients with biochemical recurrence will have active disease, therefore the estimated prevalence will be 100%. Therefore the sensitivity will be determined by the percentage of patients in which positive disease is noted. Point estimate of sensitivity will be calculated with the corresponding 95% confidence interval.

  • 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 ]
    The number of positive body regions using conventional imaging and Ga-68 HBED-CC PSMA PET will be compared.


Enrollment: 225
Actual Study Start Date: December 2015
Study Completion Date: October 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (Ga-68-HBED-CC-PSMA PET/CT or PET/MRI)
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
Drug: Ga-68 labeled HBED-CC PSMA PET imaging
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.
Other Names:
  • Ga-68 labeled DKFZ-PSMA-11
  • Ga-68 labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • Ga-68 labeled Glu-urea-Lys(Ahx)-HBED-CC

Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611882


Locations
United States, California
UCSF Imaging Center at China Basin
San Francisco, California, United States, 94107
Sponsors and Collaborators
Thomas Hope
Investigators
Principal Investigator: Thomas A Hope University of California, San Francisco
  More Information

Responsible Party: Thomas Hope, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02611882     History of Changes
Other Study ID Numbers: 15-17570
First Submitted: September 29, 2015
First Posted: November 23, 2015
Last Update Posted: November 20, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid
Edetic Acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents