Guided Biopsy for Mapping Prostate Cancer

Not Applicable

Terminated

• Conditions: Prostate Cancer
• Interventions: Procedure: Prostatectomy

• Registration Number: NCT01007214
• Lead Sponsor: Roswell Park Cancer Institute

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.

Study Timeline

• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Study Start: 2010-05
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 7

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostate cancer	Prostatectomy	A total of 30 patients diagnosed with prostate cancer who have elected to undergo radical prostatectomy are enrolled over a six year period.

Primary Outcome Measures

Name	Time	Method
Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping.	Six years

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States