Working… Menu

Guided Biopsy for Mapping Prostate Cancer (HIT)

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. Identifier: NCT01007214
Recruitment Status : Terminated (Not able to meet accrual)
First Posted : November 3, 2009
Last Update Posted : February 27, 2014
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
Evaluate the accuracy of HIT guided biopsies for mapping tumor foci with men undergoing prostatectomy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Prostatectomy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hybrid Imaging Technique (HIT) Guided Biopsy to Map Prostatic Adenocarcinoma in Patients Undergoing Prostatectomy
Study Start Date : May 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Procedure: Prostatectomy
Elective prostatectomy
Other Name: Prostate cancer

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01007214

Layout table for location information
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14141
Sponsors and Collaborators
Roswell Park Cancer Institute
Layout table for investigator information
Principal Investigator: Anurag K Singh, MD Roswell Park

Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute Identifier: NCT01007214     History of Changes
Other Study ID Numbers: I 133608
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: February 2014
Keywords provided by Roswell Park Cancer Institute:
Prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases