Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma

NCT00851682 | Terminated Results

• 1 other identifier: HRPO#03-0535
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to find out if MRI techniques examining (1) the motion of water molecules in the prostate (diffusion sensitive MRI), (2) the difference in blood flow to the prostate (dynamic contrast enhanced MRI), and (3) differences in chemical composition of the prostate (MR spectroscopy), can be used to detect prostate cancer early and non-invasively. Localization of the cancer within the prostate would be of particular importance in focal cryoablation of prostate carcinoma which we hope to improve as a result of this project. Additional aim of the study is to correlate expression of genes believed to pay a role in prostate cancer with MRI findings.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Dynamic Contrast Enhanced MRI; Non-invasive Prostate Cancer Detection

Outcome Measures

Primary Outcomes (1)

• Improved Accuracy of Prostate Cancer Detection by MRI Scan.

  Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.

  At time of treatment

Secondary Outcomes (1)

• Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.

  At time of treatment

Study Arms (2)

Radical prostatectomy patients

OTHER

Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.

Device: MRI scan

Brachytherapy patients

OTHER

Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.

Device: MRI scan

Interventions

MRI scan DEVICE

Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.

Brachytherapy patients; Radical prostatectomy patients

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who have been diagnosed with prostate cancer and are scheduled for radical prostatectomy or for brachytherapy
• patients who have not received any preoperative treatment for their diagnosis of prostate cancer

You may not qualify if:

• patients with implants that are electronically, magnetically, or mechanically active
• patients with intracranial aneurysm clips
• patients who have undergone cosmetic eyelid surgery
• patients with history of pheochromocytoma, insulinoma and acute glaucoma
• patients with estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Midwest Stone Institute.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging

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)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Robert Grubb, III
• Organization: Washington University

grubbr@wudosis.wustl.edu

314 454-7185

Study Officials

• Robert L Grubb, III, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: January 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 31, 2018
• Results First Posted: November 11, 2015

Record last verified: 2018-10

Locations

US (1)