Phase II Laser Focal Therapy of Prostate Cancer

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 prostate cancer and to evaluate oncologic control over 20 years. We hypothesize that laser focal therapy can be used to achieve oncologic control in carefully selected patients. MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses light to heat a target area to try to destroy cancerous cells. The laser system that will be used is called the Visualase® Thermal Therapy System. This system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers. However; this study is the first time this system has been studied for use in the treatment of prostate cancer with a trans-rectal approach. MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and Drug Administration (FDA) for such uses.

Sex

Male

Minimum age

45 Years

Maximum age

90 Years

Inclusion Criteria:

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 Criteria:

* 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

• BACKGROUNDGreenwood, B. et al.: Transrectal interventional MRI: initial prostate biopsy experience. SPIE Proceedings, 2010.
• BACKGROUNDHakimi AA, Feder M, Ghavamian R. Minimally invasive approaches to prostate cancer: a review of the current literature. Urol J. 2007 Summer;4(3):130-7. PMID 17987573
• BACKGROUNDMenon M, Tewari A, Peabody JO, Shrivastava A, Kaul S, Bhandari A, Hemal AK. Vattikuti Institute prostatectomy, a technique of robotic radical prostatectomy for management of localized carcinoma of the prostate: experience of over 1100 cases. Urol Clin North Am. 2004 Nov;31(4):701-17. doi: 10.1016/j.ucl.2004.06.011. PMID 15474597
• BACKGROUNDValerio M, Emberton M, Ahmed HU. Focal therapy will become a standard option for selected men with localized prostate cancer. J Clin Oncol. 2014 Nov 10;32(32):3680-1. doi: 10.1200/JCO.2014.56.7792. Epub 2014 Aug 18. No abstract available. PMID 25135989