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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02611882

Run by

Thomas Hope

People needed

225

Starts

2015-12-18

Expected to finish

2016-10-24

Last updated by the study team

2020-12-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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, Prostate-specific antigen (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 Prostate Cancer Clinical Trials Working Group (PCWG2) criteria (27).
• i. Patients with castrate resistant prostate cancer can be either on treatment or off treatment
• Age > 18.
• Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
• Ability to understand a written informed consent document, and the willingness to sign it.

You may not qualify if…

• Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
• Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
• Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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