C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma

NCT ID: NCT01530269

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2019-01-31

Brief Summary

Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.

Detailed Description

OBJECTIVES:

• Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy.
• Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PET/CT imaging with C11-Sodium Acetate

Group Type: EXPERIMENTAL

C11-Sodium Acetate

Intervention Type: DRUG

PET Imaging with C11-Sodium Acetate

Interventions

C11-Sodium Acetate

PET Imaging with C11-Sodium Acetate

Intervention Type: DRUG

Other Intervention Names

C11 Acetate PET; Carbon 11; AC-PET

Eligibility Criteria

Inclusion Criteria

Male patients will be studied who have prostate cancer:

• Diagnosed with prostate adenocarcinoma
• Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery
• Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following:

• Gleason score >= 7 or PSA >= 10
• Gleason score < 7 or PSA <10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy
• Rising or non-responding PSA

Exclusion Criteria

• < 18 years old
• claustrophobic patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Phoenix Molecular Imaging

OTHER

Sponsor Role: lead

Responsible Party

Fabio Almeida MD

Medical Director and Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabio Almeida, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Director, Phoenix Molecular Imaging

Locations

Phoenix Molecular Imaging

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

AMIC-AC-002

Identifier Type: -

Identifier Source: org_study_id