Focal Laser Ablation of the Prostate Cancer

Limitations of Radical Prostatectomy

Radical prostatectomy represents the most reliable treatment to cure prostate cancer. Historically, radical prostatectomy was associated with significant morbidity. Virtually all men developed erectile dysfunction after the surgical procedure.  In the early 1980’s, Dr Lepor delineated the precise pathway of the nerves mediating erectile function. Based on these discoveries, Drs. Walsh and Lepor described the nerve sparing radical prostatectomy which greatly improved the likelihood of preserving erectile function following the surgical procedure. Despite these modifications of surgical technique, many men experience sexual dysfunction manifested by erectile and orgasmic dysfunction.  The robotic approach has not improved any meaningful outcome following radical prostatectomy including sexual function. Dr. Lepor has published surgical outcomes in the most rigorous peer reviewed journals confirming that most men following open radical prostatectomy are discharged the next day and return to work in two week. He has also published that urinary continence and overall satisfaction with outcome following radical prostatectomy is 98% and 93%, respectively. Despite the fact he co-developed the surgical procedure and has performed 4500 radical prostatectomy, about 40% of all men undergoing the surgical procedure will develop erectile dysfunction. The likelihood erectile function will be preserved is dependent on many criteria including age, baseline erectile function, if both nerves can be preserved and if there exists cardiovascular co-morbidities. Therefore, the unmet need in the treatment of prostate cancer is an approach that reliably eradicates prostate cancer while preserving erectile function.

Spectrum of Prostate Cancer: Rationale for Focal Ablation of Prostate Cancer

The accepted treatment strategies for clinically localized prostate cancer include active surveillance vs. curative treatment (radical prostatectomy vs. radiation therapy). The age range for men referred to the Smilow Center for management of low risk prostate cancer includes men ranging from 37 to 90. The extent of cancer ranges from one microscopic focus of “low risk” disease in a single tissue core to diffuse disease occupying the majority of all of the biopsy specimens. The serum PSA may range from 1.0 to 150 mg/dl. Men also have different perceptions regarding the potential complications of intervention. Some feel they want their cancer cured and they will simply deal with quality of life side effects while others will not embark on a life saving treatment if quality of life may be impaired. Based on the spectrum of the individuals and the disease, it is hard to imagine only choices are active surveillance or curative intervention.

Prostate Cancer: A Unique Clinical Conundrum

There is no other cancer where a non specific tumor marker like PSA triggers a random biopsy of the prostate and the urologist professes to know the risk of the disease. In many of these cases the cancer is missed or an insignificant cancer is detected. What is needed is a way to image the prostate and reliably assess the site and extent of disease.

Impact of MRI on Screening, Detection and Treatment

Up until very recently, focal therapy was not feasible since we did not have a target to ablate. Prostate cancer was diagnosed by randomly obtaining prostate tissue cores under ultrasound guidance. Unfortunately, prostate cancer is not recognized by ultrasound. A routine MRI is just as unreliable as ultrasound for detection prostate cancer. Advances in multiparametric MRI (mpMRI) imaging have revolutionized the treatment of prostate cancer. NYULMC is a leader in the field of mpMRI imaging of the prostate. There is increasing evidence that in areas where the mpMRI of the prostate shows no regions of interest based on computer analysis of diffusion weighted and contrast enhancement imaging, there rarely exists significant prostate cancer whereas in regions of interest very suspicious for cancer on mpMRI, the positive predictive value for biopsy proven cancer is exceedingly high. We have so much confidence in the mpMRI that at NYULMC, we rarely perform a random prostate biopsy without obtaining an mpMRI. The mpMRI serves as the GPS of the prostate gland. A large proportion of prostate cancers are being detected on the basis of mpMRI and therefore we now have a target to ablate.

MRI Guided Focal Ablation of Prostate Cancer

Technique Over the past several years, Dr. Dan Sperling, Medical Director and Chief of Interventional Radiology at the New Jersey Institute of Radiology has pioneered a technique for focally ablating prostate cancer under MRI guidance. He has the largest experience with laser ablation of prostate cancer in the US. Drs. Lepor and Sperling perform the procedure together. The prostate is anesthetized with local anesthesia just as is done prior to a prostate biopsy. The technique is performed under local anesthesia in the MRI machine. The region of interest harboring the prostate cancer is identified and a laser fiber is introduced directly into the prostate cancer under MRI guidance. MRI is highly temperature sensitive. Therefore, the temperature of the critical structures adjacent to the prostate including the rectum, urinary sphincter, and erectile nerves are monitored in real time so it is extremely rare to have any collateral damage to these structures. The temperature of the ablation site within the region of interest known to harbor prostate cancer is also monitored in real time to optimize destruction of the indexed lesion of the cancer. At the completion of the procedure, contrast is administered to show that the region of interest has been successfully ablated.

Who is a Candidate for Focal Laser Ablation of the Prostate?

First, the candidate must have a region of interest that is seen and localized to the prostate on an mpMRI.  Ideally, the mpMRI is obtained prior to a prostate biopsy. In many cases it is performed after the biopsy. If the site of the cancer in the biopsy tissue cores and the region of interest on mpMRI are aligned, this is adequate evidence that the mpMRI region of interest reflects prostate cancer. If the mpMRI is performed prior to the biopsy, as we recommend, an MRI targeted biopsy or TRUS guided biopsy using computer co-registration will confirm that the region of interest is cancer. NYULM was one of the first centers in the world to use Eigen Artemis system and has the largest experience in the northeast with 3D MRI/Ultrasound co-registration biopsy.

The ideal candidate for this procedure is an individual who has a high priority to preserve sexual function. Ideally, there is a single prostate region of interest on the mpMRI that is confirmed by biopsy to be low or intermediate prostate cancer. In selected cases, men with multi-focal low risk cancer unrelated to a region of interest may also be candidates.

What to Expect: Short Term

The immediate post-procedure recovery is truly simple. As soon as the procedure is completed, you walk out of the MRI. You will be discharged about one hour after the procedure. The evening of the procedure you may engage in unlimited activities. Some men have chosen to have intercourse within the first three days after the procedure.

Will My Cancer Be Cured?

We do not have long term data using this technique. We believe all the disease in the region of interest will be destroyed. Based on the MRI it is unlikely you have significant disease elsewhere in the prostate. While more than likely there is prostate cancer in the non-ablated area, because of the negative mpMRI and biopsy in these areas, we do not feel an immediate need to treat beyond the region of interest. While we cannot make guarantees that all the cancer is gone and you will not develop disease progression, we believe that with careful follow up any residual disease, if it exists, will not escape our surveillance. The trade off for the requirement for future surveillance and possible re-treatment is essentially full preservation of sexual function.

Will Disease Surveillance after My Focal Laser Ablation Be Required

At the present time our surveillance protocol requires a digital rectal examination (DRE), serum PSA, PCA3 test, and mpMRI guided targeted biopsy between 3 to 6 months of the ablation. If all these tests do not indicate residual disease, these tests will be repeated at one year with the exception that a Artemis targeted biopsy of the ROI and a 12 core random biopsy will be performed under TRUS guidance. Thereafter, all of the tests with the exception of mpMRI will be performed every six months. The mpMRI will be performed annually or bi-annually. Subsequent biopsies will be performed based as the results of these surveillance tests.

Why the Sperling/Lepor team

Drs. Lepor and Sperling jointly see candidates for focal laser ablation at the Smilow Center as a team on Friday mornings. Dr. Lepor has 25 years of experience related to prostate cancer screening, diagnosis and treatment. He is a leading international authority on prostate cancer and radical prostatectomy and is in an ideal position to explain the pros and cons of focal ablation relative to other treatment options. In many cases, Dr. Lepor will discourage you from ablation since if it is not a reasonable option. Dr. Sperling is a radiologist who has spent the past several years learning and perfecting the ablation technology. He has the greatest experience performing the focal laser ablation procedures in the world.

How to Determine If Laser Ablation is Right for You?

In order to arrange a consultation, email: Lisa.Monderson@nyumc.org or call (646 825 6307) Lisa Monderson.

Costs

At the present time, laser ablation of the prostate is not FDA approved or fully covered by insurance. Many men will be able to have some of the expenses reimbursed. A billing specialist will assist with submission of claims but no guarantee for reimbursement can be made at this time.