Clinical trial NCT01007214: Guided Biopsy for Mapping Prostate Cancer
Official title: Hybrid Imaging Technique (HIT) Guided Biopsy to Map Prostatic Adenocarcinoma in Patients Undergoing Prostatectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Prostatectomy
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2009-11-03
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping.
timeFrame: Six years
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park
name: Anurag K Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: