Positron Emission Tomography in Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: carbon-11 acetate PET scan

• Registration Number: NCT00121212
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-07-19
• Study First Submitted QC: 2005-07-19
• Study First Posted: 2005-07-21
• Primary Completion: 2010-07
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 179

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery - Positive PET scan	carbon-11 acetate 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.
Radiation therapy Negative or Positive PET scan	carbon-11 acetate 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.
Surgery - Negative PET scan	carbon-11 acetate 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.

Primary Outcome Measures

Name	Time	Method
Determine the role of AC-PET in changing initial patient management	Completion of patient treatment

Secondary Outcome Measures

Name	Time	Method
Determine the value of AC-PET in predicting recurrence	Minimum of 2 years and maximum of 5 years
Assess the performance of AC-PET for detection of lymph node metastasis by comparison with biopsy.	Minimum of 2 years and maximum of 5 years

Trial Locations

Locations (1)

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis; 🇺🇸 Saint Louis, Missouri, United States