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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00851682
• Other study ID #: HRPO#03-0535
• Status: Terminated
• Phase: N/A
• Start date: January 2009
• Est. completion date: February 2014

Study information

• Verified date: October 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Radical prostatectomy patients will undergo an MRI prior to their scheduled surgery. Ex vivo imaging will be done on prostates once removed. Results from the final pathology with be compared with results of imaging to determine the accuracy of the image analysis in cancer localization and staging.

Brachytherapy patients will undergo an MRI prior to their scheduled procedure. Two areas of suspected cancer and two areas without suspected cancer will be prospectively identified based on the MRI imaging. At the time of brachytherapy, transrectal needle biopsies will be obtained from the previously identified areas. The needle cores will be reviewed by study pathologist to determine the accuracy of the image analysis in cancer localization and staging.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• MRI scan
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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Midwest Stone Institute.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.	Ultrasound guidance of transrectal ultrasound biopsy was not attempted.	At time of treatment