Skip to content

Guided Biopsy for Mapping Prostate Cancer

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01007214
Acronym
HIT
Enrollment
7
Registered
2009-11-03
Start date
2010-05-31
Completion date
2014-02-28
Last updated
2014-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, Prostatectomy

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.

Interventions

PROCEDUREProstatectomy

Elective prostatectomy

Sponsors

Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026