Positron Emission Tomography in Prostate Cancer

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

carbon-11 acetate PET scan

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Surgery - Negative PET scan

Surgery - Positive PET scan

Radiation therapy Negative or Positive PET scan

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Determine the value of AC-PET in predicting recurrence

Assess the performance of AC-PET for detection of lymph node metastasis by comparison with biopsy.

Full Information

NCT ID

NCT00121212

First Posted

July 19, 2005

Last Updated

October 28, 2015

Sponsor

Washington University School of Medicine

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00121212

Brief Title

Positron Emission Tomography in Prostate Cancer

Official Title

Positron Emission Tomography in Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

July 2003 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

179 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Surgery - Negative PET scan

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Surgery - Positive PET scan

Arm Type

Experimental

Arm Description

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.

Arm Title

Radiation therapy Negative or Positive PET scan

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

carbon-11 acetate PET scan

Primary Outcome Measure Information:

Title

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

Time Frame

Completion of patient treatment

Secondary Outcome Measure Information:

Title

Determine the value of AC-PET in predicting recurrence

Time Frame

Minimum of 2 years and maximum of 5 years

Title

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

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Farrokh Dehdashti, MD

Organizational Affiliation

Washington University Siteman Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial