Positron Emission Tomography in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Positron Emission Tomography in Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121212
• Other study ID #: CDR0000434994
• Secondary ID: R01CA101734P30CA
• Status: Completed
• Phase: N/A
• First received: July 19, 2005
• Last updated: October 28, 2015
• Start date: July 2003
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: October 2015
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• carbon-11 acetate PET scan

Locations

Country	Name	City	State
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the role of AC-PET in changing initial patient management		Completion of patient treatment	No
Secondary	Determine the value of AC-PET in predicting recurrence		Minimum of 2 years and maximum of 5 years	No
Secondary	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	No