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Evaluation of PSMA-based PET as an Imaging Biomarker of Primary Prostate Cancer

Phase 1/Phase 2
18 Years
90 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Evaluation of PSMA-based PET as an Imaging Biomarker of Primary Prostate Cancer

Inclusion Criteria:

1. Newly diagnosed prostate cancer pathologically proven by prostate biopsy

2. Prostate biopsy histology grade ≥ Gleason 4+3=7

3. Patients considered as candidates for and medically fit to undergo prostatectomy

4. At least 10 days after most recent prostate biopsy

5. No known problems with peripheral IV or central line access

6. Able to tolerate urinary straight catheter placement

7. Patient is judged by the Investigator to have the initiative and means to be
compliant with the protocol and be within geographical proximity to make the required
study visits.

8. Patients or their legal representatives must have the ability to read, understand and
provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

1. Prior pelvic external beam radiation therapy or brachytherapy

2. Chemotherapy for prostate cancer

3. Hormone deprivation therapy

4. Investigational therapy for prostate cancer

5. Hemorrhagic cystitis or active prostatitis

6. Unable to lie flat during or tolerate PET/CT

7. Prior history of any other malignancy within last 2 years, other than skin basal cell

8. No prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging)

9. Serum creatinine > 1.5 mg/dL or creatinine clearance < 50 mL/min/1.73m2


Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

PET detection of primary prostate cancer

Outcome Description:

To compare the detection and sextant localization of primary prostate cancer by DCFBC PET to prostatectomy pathology as determined by tissue step-section analysis in men with biopsy-positive prostate cancer (Gleason score > 4+3=7).

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Steve Y. Cho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Primary Prostate Cancer
  • Prostatic Neoplasms



Johns Hopkins UniversityBaltimore, Maryland  21205