Laser Based Focal Ablation of Low Grade Prostate Cancer

NCT ID: NCT01192438

Last Updated: 2014-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer.

Detailed Description

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Conditions

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Low Grade Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Procedure/surgery

Group Type EXPERIMENTAL

Laser-based thermotherapy

Intervention Type PROCEDURE

MRI-guided transperineal placement of a laser probe into the prostate

Interventions

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Laser-based thermotherapy

MRI-guided transperineal placement of a laser probe into the prostate

Intervention Type PROCEDURE

Other Intervention Names

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Visualase, Inc

Eligibility Criteria

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Inclusion Criteria

* Male, 45 years of age or older
* Diagnosis of prostate adenocarcinoma
* Clinical stage T1c or T2a
* Gleason score of 7 or less
* A minimum of 12 biopsy cores sampled during diagnostic biopsy
* Three or fewer biopsy cores with prostate cancer
* No single biopsy core with greater than 50% of tumor involvement
* A radiographically visible prostate lesion on MRI with concordance to biopsy sextant
* A documented Karnofsky performance status of at least 70
* Estimated survival of 20 years or greater, as determined by treating physician
* Ability to give informed consent

Exclusion Criteria

* Previous surgery, radiation, or androgen deprivation therapy for prostate cancer
* Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
* History of previous pelvic radiation
* Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. (See Appendix A)
* History of other primary non-skin malignancy within previous three years
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Visualase, Inc.

INDUSTRY

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott E Eggener, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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09-364A

Identifier Type: -

Identifier Source: org_study_id

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