Skip to main content
OpenTrials
Completed

NCT Number: NCT01530269

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Phoenix Molecular Imaging

Phoenix, Arizona, 85040, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C11-Sodium Acetate

Drug

PET Imaging with C11-Sodium Acetate

Other names: C11 Acetate PET, Carbon 11, AC-PET

Primary outcomes

  1. Tissue Biopsy of metastatic site(s)

    Time frame: Assessed within 30 days following AC-PET

    Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT

Secondary outcomes

  1. PSA (prostate specific antigen)

    Time frame: Each 3 - 6 months for 24 months

    PSA (prostate specific antigen) will be monitored per routine clinical follow-up

Sponsors and collaborators

Lead sponsor

Phoenix Molecular Imaging

Other

Registry information

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Feb 9, 2012
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.