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Positron Emission Tomography in Prostate Cancer


N/A
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Positron Emission Tomography in Prostate Cancer


The overall goal of this project is determination of the role of PET in patients with newly
diagnosed medium- and high-risk prostate cancer in whom the standard clinical and imaging
workup is negative. Thus, the incremental value of PET will be determined in this important
group.

Inclusion Criteria


Inclusion Criteria

- Newly diagnosed prostate cancer

- Has completed conventional staging examinations, including biopsy with Gleason score,
CT scan of the abdomen and pelvis, and whole-body bone scintigraphy AND conventional
staging examinations negative

- Candidate for curative radical prostatectomy OR curative radiotherapy OR staging
lymphadenectomy prior to surgery

- Deemed to be at medium or high risk for recurrence after initial curative treatment,
as defined by 1 of the following criteria:

- Gleason score 7 AND prostate-specific antigen (PSA) 10-20 ng/mL

- Gleason score ≥ 8 AND PSA < 10 ng/mL

- Gleason score ≥ 8 AND PSA > 10 ng/mL

- Any Gleason score AND PSA > 20 ng/mL

Exclusion Therapy:

- Not a candidate for treatment by surgery or radiation therapy with curative intent

- Inability to give informed consent

- Patients with other invasive malignancies, with the exception of non-melanoma skin
cancer, who had (or have) any evidence of other cancer present within the last 5
years

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determine the role of AC-PET in changing initial patient management

Outcome Time Frame:

Completion of patient treatment

Safety Issue:

No

Principal Investigator

Farrokh Dehdashti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000434994

NCT ID:

NCT00121212

Start Date:

July 2003

Completion Date:

July 2014

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110