Clinical trial NCT00121212: Positron Emission Tomography in Prostate Cancer
Official title: Positron Emission Tomography in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-07-21
Enrollment: 179
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Determine the role of AC-PET in changing initial patient management
timeFrame: Completion of patient treatment
Secondary outcomes:
measure: Determine the value of AC-PET in predicting recurrence
timeFrame: Minimum of 2 years and maximum of 5 years
measure: Assess the performance of AC-PET for detection of lymph node metastasis by comparison with biopsy.
timeFrame: Minimum of 2 years and maximum of 5 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
state: Missouri
Study officials:
affiliation: Washington University Siteman Cancer Center
name: Farrokh Dehdashti, MD
role: STUDY_CHAIR
References: