Guided Biopsy for Mapping Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Evaluate the accuracy of HIT guided biopsies for mapping tumor foci with men undergoing prostatectomy.

Detailed Description
-----------------
The objective of this study is to determine the accuracy of HIT (Hybrid Imaging Technology) guided biopsies for mapping tumor foci with men undergoing prostatectomy. Using a prostate hybrid imaging technology (HIT) which fuses a previously obtained endorectal MR image to transrectal ultrasound (TRUS) image to allow identification and biopsy of tumors by MR imaging in real time. We hypothesis that HIT guided biopsies will accurately localize the foci of prostate cancer.

Official Title
-----------------
Hybrid Imaging Technique (HIT) Guided Biopsy to Map Prostatic Adenocarcinoma in Patients Undergoing Prostatectomy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Prostatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have histologically confirmed diagnosis of prostate cancer Patients must have elected to undergo radical prostatectomy using an open, laparoscopic or robotic approach Patients must be at least 18 years of age and able to provide written informed consent. No history of radiotherapy, chemotherapy or hormone therapy within 6 months of surgery Primary tumor must be amenable to surgical removal for curative intent Patients must have ECOG-performance status 0 or 1 (appendix II) Patients must have no history of rectal or anal disease. Patients must have adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT])≤2.5x local laboratory upper limit of normal (ULN), or AST and ALT ≤5x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin ≤1.5 x ULN Absolute neutrophil count(ANC)≥1,500/microL Platelets≥lOO,OOO/microL Hemoglobin≥9.0 g/dL Serum calcium≤10.2mg/dL (correct for low albumin if necessary; calcium + (normal albumin - serum albumin)x 0.8) Patients must have serum creatinine<2 mg/dL or serum creatinine clearance (CrCl)>40ml/min(CrCl= Wt(kg)x(140-age)*/72xCr. level,*female x 0.85) Inclusion of minorities: Members of all races and ethnic groups are eligible for this trial. Women and children are not eligible since prostate cancer is not diagnosed in these groups.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate cancer<br>A total of 30 patients diagnosed with prostate cancer who have elected to undergo radical prostatectomy are enrolled over a six year period. | Procedure: Prostatectomy<br>* Elective prostatectomy<br>* Other names: Prostate cancer;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping. |  | Six years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, Prostatectomy