Status:
ACTIVE_NOT_RECRUITING
Phase II Laser Focal Therapy of Prostate Cancer
Lead Sponsor:
HALO Diagnostics
Conditions:
Prostate Cancer
Eligibility:
MALE
45-90 years
Brief Summary
Target recruitment: 1000 subjects. The purpose of this research study is to continue to investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal therapy for prostat...
Detailed Description
Laser-induced interstitial thermal therapy (LITT) is a novel form of controlled, targeted thermal ablation that may offer measurable advantages over other ablative therapies for focal prostate therapy...
Eligibility Criteria
Inclusion
- Treatment Naïve patients:
- Male, 45 years of age or older.
- Diagnosis of prostate adenocarcinoma.
- Clinical stage T1c or T2a.
- Gleason score of 7 (3+4 or 4+3) or less.
- Three or fewer biopsy cores with prostate cancer.
- PSA density not exceeding 0.375.
- One, two, or three tumor suspicious regions identified on multiparametric MRI.
- Negative radiographic indication of extra-capsular extent.
- Karnofsky performance status of at least 70.
- Estimated survival of 5 years or greater, as determined by treating physician.
- Tolerance for anesthesia/sedation.
- Ability to give informed consent.
- At least 6 weeks since any previous prostate biopsy.
- MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less.
- Salvage candidates will be accepted upon physician referral.
Exclusion
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater
- History of other primary non-skin malignancy within previous three years.
- Diabetes
- Smoker
Key Trial Info
Start Date :
May 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2036
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT02243033
Start Date
May 1 2016
End Date
November 1 2036
Last Update
March 25 2022
Active Locations (1)
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1
Desert Medical Imaging
Indian Wells, California, United States, 92210