Positron Emission Tomography in Prostate Cancer

The Washington University

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: carbon-11 acetate PET scan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00121212

WU-03-0315

R01CA101734 (U.S. NIH Grant/Contract)

CDR0000434994

P30CA091842 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 179 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 3 patient groups

Surgery - Negative PET scan

Active Comparator group

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.

Treatment:

Procedure: carbon-11 acetate PET scan

Surgery - Positive PET scan

Experimental group

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.

Treatment:

Procedure: carbon-11 acetate PET scan

Radiation therapy Negative or Positive PET scan

Active Comparator group

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.

Treatment:

Procedure: carbon-11 acetate PET scan