PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma

Prostate Cancer Clinical Trial

Official title:

Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304485
• Other study ID #: AMIC-AC-001
• Status: Completed
• Phase: Phase 2
• Start date: April 2011
• Est. completion date: January 2019

Study information

• Verified date: March 2019
• Source: Phoenix Molecular Imaging
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy

Description:

The goal of this project is improved imaging of prostate cancer by positron emission tomography (PET) with use of the radiopharmaceutical C-11 Acetate, utilizing state-of-the-art PET/CT camera technology and processing algorithms.

A successful effort will lead to more accurate diagnosis of recurrence in patients with prostate cancer to allow for early directed therapy. This study is designed to generate data to add to the understanding of the effectiveness of C-11 Acetate, focusing on patients with recurrent or persistent disease after prostatectomy or radiation therapy.

The study is designed to expand on the database of C11-Acetate PET imaging in patients with prior definitive therapy for prostate cancer and evidence of biochemical recurrence (post therapy rise in PSA), and to evaluate the relationship between detection on C11-Acetate PET imaging, PSA (Trigger, Velocity and Doubling Time) and FDG PET imaging.

Specific questions to be addressed:

1. What is the yield of current state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease in this patient population?

2. How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET), Sodium F18 PET bone scans and with that of CT?

3. What is the optimal imaging protocol in terms of imaging time after injection?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• recurrent prostate cancer (detectable PSA following radical prostatectomy or rising PSA in patients with radiation therapy as the primary treatment)

Exclusion Criteria:

• < 18 years old

• claustrophobic patients

Related Conditions & MeSH terms

• Carcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Sodium Acetate C11
PET Imaging with Sodium Acetate C11

Locations

Country	Name	City	State
United States	Phoenix Molecular Imaging	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Molecular Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUV (Standardized Uptake Value)	Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest.	Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration
Secondary	PSA (prostate specific antigen)	PSA will be monitored per routine clinical follow-up.	Every 3 - 6 months for 24 months after PET imaging