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

Phase 2

Completed

• Conditions: Prostate Cancer; Prostate Adenocarcinoma
• Interventions: Drug: C11-Sodium Acetate

• Registration Number: NCT01530269
• Lead Sponsor: Phoenix Molecular Imaging

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.

Study Timeline

• Study First Submitted: 2012-02-04
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-09
• Study Start: 2012-04
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/CT imaging with C11-Sodium Acetate	C11-Sodium Acetate	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Phoenix Molecular Imaging; 🇺🇸 Phoenix, Arizona, United States