Guided Biopsy for Mapping Prostate Cancer (HIT)

This study has been terminated.
(Not able to meet accrual)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01007214
First received: October 29, 2009
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Prostate Cancer
Procedure: Prostatectomy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Hybrid Imaging Technique (HIT) Guided Biopsy to Map Prostatic Adenocarcinoma in Patients Undergoing Prostatectomy

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping. [ Time Frame: Six years ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: May 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • Prostate cancer
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007214

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14141
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Anurag K Singh, MD Roswell Park
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01007214     History of Changes
Other Study ID Numbers: I 133608
Study First Received: October 29, 2009
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
Prostate cancer
Prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014