Guided Biopsy for Mapping Prostate Cancer

NCT01007214 | Terminated DMC

• 1 other identifier: I 133608
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Prostate cancer; Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping.

  Six years

Study Arms (1)

Prostate cancer

EXPERIMENTAL

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

Procedure: Prostatectomy

Interventions

Prostatectomy PROCEDURE

Elective prostatectomy

Also known as: Prostate cancer

Prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14141, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Prostatectomy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Anurag K Singh, MD

  Roswell Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: November 3, 2009
• Study Start: May 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 27, 2014

Record last verified: 2014-02

Locations

US (1)