Guided Biopsy for Mapping Prostate Cancer (HIT)

Tracking Information
First Submitted Date ICMJE	October 29, 2009
First Posted Date ICMJE	November 3, 2009
Last Update Posted Date	February 27, 2014
Study Start Date ICMJE	May 2010
Actual Primary Completion Date	February 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 5, 2012)	Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping. [ Time Frame: Six years ]
Original Primary Outcome Measures ICMJE; (submitted: November 2, 2009)	Determine accuracy of hybrid image technology guided biopsies for prostate cancer mapping. [ Time Frame: 8/2010 ]
Change History	Complete list of historical versions of study NCT01007214 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Guided Biopsy for Mapping Prostate Cancer
Official Title ICMJE	Hybrid Imaging Technique (HIT) Guided Biopsy to Map Prostatic Adenocarcinoma in Patients Undergoing Prostatectomy
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Prostate Cancer
Intervention ICMJE	Procedure: Prostatectomy; Elective prostatectomy; Other Name: Prostate cancer
Study Arms	Experimental: Prostate cancer; A total of 30 patients diagnosed with prostate cancer who have elected to undergo radical prostatectomy are enrolled over a six year period.; Intervention: Procedure: Prostatectomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: February 26, 2014)	7
Original Estimated Enrollment ICMJE; (submitted: November 2, 2009)	30
Actual Study Completion Date	February 2014
Actual Primary Completion Date	February 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01007214
Other Study ID Numbers ICMJE	I 133608
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Roswell Park Cancer Institute
Study Sponsor ICMJE	Roswell Park Cancer Institute
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Anurag K Singh, MD Roswell Park
PRS Account	Roswell Park Cancer Institute
Verification Date	February 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP