Guided Biopsy for Mapping Prostate Cancer

Prostate Cancer Clinical Trial

— HIT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01007214
• Other study ID #: I 133608
• Status: Terminated
• Phase: N/A
• First received: October 29, 2009
• Last updated: February 26, 2014
• Start date: May 2010
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Prostatectomy
Elective prostatectomy

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping.		Six years	No