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

Sponsor

Phoenix Molecular Imaging (Other)

Overall Status

Completed

CT.gov ID

NCT01530269

Collaborator

(none)

300

Enrollment

Location

Arm

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostate Adenocarcinoma	Drug: C11-Sodium Acetate	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PET/CT imaging with C11-Sodium Acetate	Drug: C11-Sodium Acetate PET Imaging with C11-Sodium Acetate Other Names: C11 Acetate PET Carbon 11 AC-PET

Arm

Intervention/Treatment

Experimental: PET/CT imaging with C11-Sodium Acetate

Drug: C11-Sodium Acetate

PET Imaging with C11-Sodium Acetate

Other Names:

C11 Acetate PET

Carbon 11

AC-PET

Outcome Measures

Primary Outcome Measures

Tissue Biopsy of metastatic site(s) [Assessed within 30 days following AC-PET]
Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT

Secondary Outcome Measures

PSA (prostate specific antigen) [Each 3 - 6 months for 24 months]
PSA (prostate specific antigen) will be monitored per routine clinical follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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