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OpenTrials
Completed

NCT Number: NCT00121212

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carbon-11 acetate PET scan

Procedure

Primary outcomes

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

    Time frame: Completion of patient treatment

Secondary outcomes

  1. Determine the value of AC-PET in predicting recurrence

    Time frame: Minimum of 2 years and maximum of 5 years

  2. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2003
Primary completion
2010
Study completion
2015
First posted
Jul 21, 2005
Registry last updated
Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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