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Completed

NCT Number: NCT01192438

Laser Based Focal Ablation of Low Grade Prostate Cancer

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

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Key information

Conditions

Low Grade Prostate Cancer Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60616, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser-based thermotherapy

Procedure

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

Other names: Visualase, Inc

Primary outcomes

  1. Number of patients with adverse events

    Time frame: Within 6 months of the procedure

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Visualase, Inc.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 1, 2010
Registry last updated
Mar 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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