Laser Based Focal Ablation of Low Grade Prostate Cancer

Low Grade Prostate Cancer Clinical Trial

Official title:

A Pilot Study to Evaluate Magnetic Resonance Thermal Image-guided Laser-Induced Interstitial Thermal Therapy for Focal Ablation of Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192438
• Other study ID #: 09-364A
• Status: Completed
• Phase: N/A
• First received: August 27, 2010
• Last updated: March 26, 2014
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: March 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Grade Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Laser-based thermotherapy
MRI-guided transperineal placement of a laser probe into the prostate

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Visualase, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events		Within 6 months of the procedure	Yes