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

• Status: Completed
• Trial end date: 2016-10-24
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Hope
• Treatments: Edetic Acid; N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid

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, 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

2. Age > 18.

3. Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (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.).