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

Phoenix Molecular Imaging

Status and phase: Completed; Phase 2

Conditions: Prostate Adenocarcinoma; Prostate Cancer

Treatments: Drug: C11-Sodium Acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT01530269

AMIC-AC-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No 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

Exclusion criteria

• < 18 years old
• claustrophobic patients

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

PET/CT imaging with C11-Sodium Acetate

Experimental group

Treatment:

Drug: C11-Sodium Acetate