Positron Emission Tomography in Prostate Cancer

NCT ID: NCT00121212

Last Updated: 2015-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

carbon-11 acetate PET scan

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

carbon-11 acetate PET scan

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

carbon-11 acetate PET scan

Intervention Type PROCEDURE

Interventions

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carbon-11 acetate PET scan

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Farrokh Dehdashti, MD

Role: STUDY_CHAIR

Washington University Siteman Cancer Center

Locations

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Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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R01CA101734

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA091842

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WU-03-0315

Identifier Type: -

Identifier Source: secondary_id

CDR0000434994

Identifier Type: -

Identifier Source: org_study_id

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