Summary

for males ages 19 years and up (full criteria)
at San Francisco, California
study started
estimated completion
Thomas Hope

Description

Summary

The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.

Details

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is 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. PET imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues

Primary Objective:

Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

Keywords

Prostate Cancer Prostatic Neoplasms Edetic Acid Ga-68 labeled PSMA-11 Positron emission tomography-computed tomography (PET/CT) Positron emission tomography-magnetic resonance imaging (PET/MRI) Ga-68 labeled PSMA-11 PET PSMA

Eligibility

You can join if…

Open to males ages 19 years and up

  1. Male, age ≥ 18.
  2. Histopathologically proven prostate adenocarcinoma.
  3. Concern for metastatic disease in one of the following settings:
  4. Initial staging with intermediate to high risk prostate cancer.
  5. Biochemical recurrence after initial therapy.
  6. Ability to understand a written informed consent document, and the willingness to sign it.

You CAN'T join if...

  1. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Thomas Hope
ID
NCT03803475
Phase
Phase 3
Study Type
Interventional
Last Updated