NCT00121212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

7 years

First QC Date

July 19, 2005

Last Update Submit

October 28, 2015

Conditions

Prostate Cancer

Keywords

stage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancer

Outcome Measures

Primary Outcomes (1)

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

    Completion of patient treatment

Secondary Outcomes (2)

  • 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

Study Arms (3)

Surgery - Negative PET scan

ACTIVE COMPARATOR

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

Surgery - Positive PET scan

EXPERIMENTAL

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

Radiation therapy Negative or Positive PET scan

ACTIVE COMPARATOR

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

Interventions

carbon-11 acetate PET scanPROCEDURE
Radiation therapy Negative or Positive PET scanSurgery - Negative PET scanSurgery - Positive PET scan

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Farrokh Dehdashti, MD

    Washington University Siteman Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2005

First Posted

July 21, 2005

Study Start

July 1, 2003

Primary Completion

July 1, 2010

Study Completion

October 1, 2015

Last Updated

October 30, 2015

Record last verified: 2015-10

Locations

US(1)