Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients

Last updated: November 13, 2020
Sponsor: University of California, San Francisco
Overall Status: Completed

Phase

2/3

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

N/A

Clinical Study ID

NCT02919111
16559
NCI-2018-00038
  • Ages > 18
  • Male

Study Summary

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Biopsy proven prostate adenocarcinoma.
  • Planned prostatectomy with lymph node dissection.
  • Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or otherrisk factors).
  • Diagnostic CT or MRI as part of the PET study or performed within one month of PSMAPET.
  • Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
  • Age > 18.
  • Ability to understand a written informed consent document, and the willingness to signit.

Exclusion

Exclusion Criteria:

  • Patients not capable of getting PET study due to weight, claustrophobia, or inabilityto lay still for the duration of the exam.
  • Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy.
  • Including focal ablation techniques (HiFu).
  • Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging andsurgery.

Study Design

Total Participants: 299
Study Start date:
September 23, 2016
Estimated Completion Date:
December 31, 2019

Study 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 PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis.

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 Ga-68-PSMA-11 to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval.

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94107
    United States

    Site Not Available

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