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

NCT01530269 | Completed Phase 2

• 1 other identifier: AMIC-AC-002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

intermediate; high; risk; radiation; therapy; planning; surgical; immunotherapy; chemotherapy; hormone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PSA (prostate specific antigen)

  Each 3 - 6 months for 24 months

Study Arms (1)

PET/CT imaging with C11-Sodium Acetate

EXPERIMENTAL

Drug: C11-Sodium Acetate

Interventions

C11-Sodium Acetate DRUG

PET Imaging with C11-Sodium Acetate

Also known as: C11 Acetate PET, Carbon 11, AC-PET

PET/CT imaging with C11-Sodium Acetate

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 18 years old
• claustrophobic patients

Sponsors & Collaborators

• Phoenix Molecular Imaging: lead

Study Sites (1)

Phoenix Molecular Imaging

Phoenix, Arizona, 85040, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Carbon-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Fabio Almeida, MD

  Medical Director, Phoenix Molecular Imaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director and Principal Investigator

Study Record Dates

• First Submitted: February 4, 2012
• First Posted: February 9, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)