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Hybrid Imaging Technique (HIT) Guided Biopsy to Map Prostatic Adenocarcinoma in Patients Undergoing Prostatectomy

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Hybrid Imaging Technique (HIT) Guided Biopsy to Map Prostatic Adenocarcinoma in Patients 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.

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

- No history of radiotherapy, chemotherapy or hormone therapy within 6 months of

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping.

Outcome Time Frame:

Six years

Safety Issue:


Principal Investigator

Anurag K Singh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park


United States: Food and Drug Administration

Study ID:

I 133608



Start Date:

May 2010

Completion Date:

May 2016

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Prostatectomy
  • Prostatic Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263