Positron Emission Tomography in Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00121212
First received: July 19, 2005
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

RATIONALE: Diagnostic procedures, such as positron emission tomography using carbon-11 acetate, may help find metastases from prostate cancer and may help predict whether prostate cancer will come back after treatment.

PURPOSE: This clinical trial is studying how well positron emission tomography using carbon-11 acetate works in finding metastases and predicting recurrence in patients with prostate cancer who are at risk for recurrence after treatment.


Condition Intervention
Prostate Cancer
Procedure: carbon-11 acetate PET scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Positron Emission Tomography in Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Determine the role of AC-PET in changing initial patient management [ Time Frame: Completion of patient treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the value of AC-PET in predicting recurrence [ Time Frame: Minimum of 2 years and maximum of 5 years ] [ Designated as safety issue: No ]
  • Assess the performance of AC-PET for detection of lymph node metastasis by comparison with biopsy. [ Time Frame: Minimum of 2 years and maximum of 5 years ] [ Designated as safety issue: No ]

Enrollment: 179
Study Start Date: July 2003
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgery - Negative PET scan
If patient is candidate for surgery with curative intent or staging lymphadenectomy, he will be enrolled in the study. If patient's PET scan is negative, the patient will receive the curative therapy and be followed for recurrence.
Procedure: carbon-11 acetate PET scan
Experimental: Surgery - Positive PET scan
If patient is candidate for surgery with curative intent or staging lymphadenectomy, he will be enrolled in the study. If patient's PET scan is positive, the patient will receive the curative therapy and be followed for recurrence or receive alternative therapy.
Procedure: carbon-11 acetate PET scan
Active Comparator: Radiation therapy Negative or Positive PET scan
If patient is candidate for radiation therapy with curative intent, he will be enrolled. If PET scan is negative he will receive curative therapy and be followed for PSA recurrence. If PET scan is positive he may receive confirmatory studies and then if negative, not indicated, or refused he will receive curative therapy be followed for PSA recurrence. If PET scan is positive and received positive confirmatory studies he will receive curative therapy and followed for recurrence.
Procedure: carbon-11 acetate PET scan

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121212

Locations
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Study Chair: Farrokh Dehdashti, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00121212     History of Changes
Other Study ID Numbers: CDR0000434994, R01CA101734, P30CA091842, WU-03-0315
Study First Received: July 19, 2005
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 20, 2014