Laser Based Focal Ablation of Low Grade Prostate Cancer | NCT01192438

Studies
Laser Based Focal Ablation of Low Grade Prostate Cancer

NCT01192438

Sponsor

University of Chicago

Status

Completed

Last Update Posted

Mar 27, 2014Estimated

Enrollment

9Actual

Phase

Not Applicable

Conditions

Low Grade Prostate Cancer

Interventions

Laser-based thermotherapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Aug 27, 2010

First Submission Date that Met QC Criteria

Aug 31, 2010

First Posted Date

Sep 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2014

Last Update Posted Date

Mar 27, 2014Estimated

Name	Class
Visualase, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Procedure/surgery	Experimental		Procedure: Laser-based thermotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser-based thermotherapy	Procedure	MRI-guided transperineal placement of a laser probe into the prostate	Procedure/surgery

Measure	Description	Time Frame
Number of patients with adverse events		Within 6 months of the procedure

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided