Clinical trial NCT00851682: Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma
Official title: Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Dynamic Contrast Enhanced MRI
Non-invasive Prostate Cancer Detection
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Midwest Stone Institute.
First posted: 2009-02-26
Enrollment: 65
Sex: MALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improved Accuracy of Prostate Cancer Detection by MRI Scan.
timeFrame: At time of treatment
Secondary outcomes:
measure: Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.
timeFrame: At time of treatment
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Robert L Grubb, III, M.D.
role: PRINCIPAL_INVESTIGATOR
References: