Guided Biopsy for Mapping Prostate Cancer (HIT)

Roswell Park Comprehensive Cancer Center

Status

Terminated

Conditions

Prostate Cancer

Treatments

Procedure: Prostatectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01007214

I 133608

Details and patient eligibility

About

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

Full 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.

Enrollment

7 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.