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

The Washington University

Status: Terminated

Conditions: Prostate Cancer

Treatments: Device: MRI scan

Study type: Interventional

Funder types: Other

Identifiers

NCT00851682

HRPO#03-0535

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: Male

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

65 participants in 2 patient groups

Radical prostatectomy patients

Other group

Description:

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.

Treatment:

Device: MRI scan

Brachytherapy patients

Other group

Description:

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

Treatment:

Device: MRI scan