Trial record 1 of 1 for: 01007214

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Guided Biopsy for Mapping Prostate Cancer (HIT)

This study has been terminated.

(Not able to meet accrual)

Sponsor:

ClinicalTrials.gov Identifier:

NCT01007214

First Posted: November 3, 2009

Last Update Posted: February 27, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Roswell Park Cancer Institute

Tracking Information

First Submitted Date ^ICMJE

October 29, 2009

First Posted Date ^ICMJE

November 3, 2009

Last Update Posted Date

February 27, 2014

Start Date ^ICMJE

May 2010

Primary Completion Date

February 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping. [ Time Frame: Six years ]

Original Primary Outcome Measures ^ICMJE

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 Provided

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

Enrollment ^ICMJE

Completion Date

February 2014

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

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

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