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


Phase 1
45 Years
N/A
Not Enrolling
Male
Low Grade Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of patients with adverse events

Outcome Time Frame:

Within 6 months of the procedure

Safety Issue:

Yes

Principal Investigator

Scott E Eggener, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

09-364A

NCT ID:

NCT01192438

Start Date:

January 2010

Completion Date:

September 2011

Related Keywords:

  • Low Grade Prostate Cancer
  • prostate
  • cancer
  • ablation
  • laser-induced
  • focal therapy
  • Prostatic Neoplasms

Name

Location

University of ChicagoChicago, Illinois  60637