Positron Emission Tomography in Prostate Cancer

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 179
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the role of AC-PET in changing initial patient management	Completion of patient treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Farrokh Dehdashti, MD, Washington University Siteman Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 19, 2005
• First Submitted That Met QC Criteria: July 19, 2005
• First Posted (Estimate): July 21, 2005

Study Record Updates

• Last Update Posted (Estimate): October 30, 2015
• Last Update Submitted That Met QC Criteria: October 28, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: stage III prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CDR0000434994; P30CA091842 (U.S. NIH Grant/Contract); R01CA101734 (U.S. NIH Grant/Contract); WU-03-0315