NCT01192438

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

March 27, 2014

Status Verified

March 1, 2014

Enrollment Period

1.7 years

First QC Date

August 27, 2010

Last Update Submit

March 26, 2014

Conditions

Low Grade Prostate Cancer

Keywords

prostatecancerablationlaser-inducedfocal therapy

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events

    Within 6 months of the procedure

Study Arms (1)

Procedure/surgery

EXPERIMENTAL
Procedure: Laser-based thermotherapy

Interventions

Laser-based thermotherapyPROCEDURE

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

Also known as: Visualase, Inc
Procedure/surgery

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Scott E Eggener, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2010

First Posted

September 1, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

March 27, 2014

Record last verified: 2014-03

Locations

US(1)