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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:
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

October 29, 2009
February 26, 2014
May 2010
February 2014   (final data collection date for primary outcome measure)
Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping. [ Time Frame: Six years ] [ Designated as safety issue: No ]
Determine accuracy of hybrid image technology guided biopsies for prostate cancer mapping. [ Time Frame: 8/2010 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01007214 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Guided Biopsy for Mapping Prostate Cancer
Hybrid Imaging Technique (HIT) Guided Biopsy to Map Prostatic Adenocarcinoma in Patients Undergoing Prostatectomy

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
Procedure: Prostatectomy
Elective prostatectomy
Other Names:
  • Prostate cancer
  • Prostatectomy
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01007214
I 133608
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Not Provided
Principal Investigator: Anurag K Singh, MD Roswell Park
Roswell Park Cancer Institute
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP