C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer

NCT00804245 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: IRB00005483P30CA012197CCCWFU-85207
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: New diagnostic procedures, such as C-11 choline PET-CT scan, may be effective in finding cancer that has spread to the bone and lymph nodes in patients with prostate cancer. PURPOSE: This clinical trial is studying how well C-11 choline PET-CT scan works in finding metastases in patients with newly diagnosed high-risk prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans

  To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease.

  Approximately 1 year

Study Arms (1)

radiolabeled choline tracer scans

EXPERIMENTAL

PET-CT scans supplemented with Choline 11 tracer

Procedure: needle biopsy; Drug: PET-CT scans supplemented with 11C-Choline tracer

Interventions

needle biopsy PROCEDURE

Biopsy of positive findings found on CT scan

radiolabeled choline tracer scans

PET-CT scans supplemented with 11C-Choline tracer DRUG

Use of 11C-Choline tracer to enhance diagnostic utility of 11C-Choline tracer

radiolabeled choline tracer scans

Eligibility Criteria

• Age: 30 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate
• Prior negative prostate biopsy allowed
• High-risk disease, as defined by one of the following:
• PSA ≥ 20 ng/mL
• Gleason score ≥ 8
• Digital rectal examination revealing ≥ T2c disease (tumor involving more than one half of one lobe of the prostate)
• Creatinine \< 2.0 mg/dL
• Able to tolerate PET scan, CT scan, and bone scan
• Able to tolerate IV and oral contrast
• Willing to undergo biopsy of positive findings on PET-CT scan, CT scan, or bone scan

You may not qualify if:

• Other cancer within the past 5 years (except for nonmelanoma skin cancer)
• No prior radiotherapy, hormonal therapy, surgery (other than biopsy), or cryotherapy for prostate cancer Prior transurethral resection of the prostate allowed

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy, Needle

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Pradeep Garg, PhD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2013
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

US (1)