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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530269
• Other study ID #: AMIC-AC-002
• Status: Completed
• Phase: Phase 2
• Start date: April 2012
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Neoplasm Metastasis
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

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	Tissue Biopsy of metastatic site(s)	Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT	Assessed within 30 days following AC-PET
Secondary	PSA (prostate specific antigen)	PSA (prostate specific antigen) will be monitored per routine clinical follow-up	Each 3 - 6 months for 24 months