The purpose of this and upcoming articles is to help familiarize our medical community on the advances in screening, diagnosis, risk stratification and new treatment paradigms for prostate cancer. I want to begin with an introduction to Focal Ablation for Prostate Cancer. But first, a look back in time to gain some perspective.
On May 5, 1993, the New York Times published an article entitled “Why Do So Many Women Have Breasts Removed Needlessly?” By that time numerous well designed studies demonstrated equivalent survival among women with Stage I and II breast cancer, whether they had radical mastectomies or lumpectomies with or without radiation therapy. In fact, a consensus of renowned breast cancer experts estimating that only about 10 % of women actually required radical breast surgery. Nonetheless, the article illuminated the unsettling fact that between 50 and 80 % of women received the more aggressive, and more physically and psychologically challenging treatment. Ultimately, legislation had to be passed at the State and Federal levels to ensure women were apprised of alternative breast cancer options.
Historically, localized prostate cancer has been treated with “Whole-gland” therapies including radical prostatectomy and radiation therapy. Although these treatments have been curative for many men, not all men are cured, not all men need treatment for localized prostate cancer and side effects in terms of sexual, bladder and bowel function can be life altering for men.
So, can we apply what we belatedly learned from the breast cancer model to that of prostate cancer?
I believe the answer is an emphatic YES. It is now generally acknowledged that a great percentage, conservatively estimated to be at least 50 % of men (and probably higher) are diagnosed with “non-lethal” prostate cancer. That is, cancers that do not need to be discovered and certainly not treated. This can be due to the overdiagnosis of low risk, indolent cancers or by diagnosing men who will not outlive the cancers they harbor. We are getting better at discerning between the two groups and I’ll have more to say in another contribution.
For those men with potentially lethal prostate cancer, can we offer them “focal” rather than “whole” prostate cancer therapy? Can we still cure the cancer? Will the benefits be worth it to these men?
The concept of the “Index Lesion” lays the foundation for consideration of focal ablative therapy (Ahmed, NEJM 1999). This concept holds that if a prostate harbors a potentially lethal prostate cancer, then the cells that will most likely metastasize originate from the index or the dominant lesion. Therefore, treating the Index Lesion with a margin of normal prostate tissue is goal.
To answer these questions, we have embarked on a project to determine and corroborate critical elements of this problem:
- Can potentially lethal prostate cancer be discovered at a time when focal therapy is possible?
- Can we successfully stratify a man’s risk for lethal prostate cancer?
- Is there safe, effective, convenient and affordable focal therapy technology to offer our patients?
- Are side effects really reduced?
- Are patients satisfied with this option?
Based upon my initial experience with Focal Therapy along with the encouraging published works of brilliant pioneers in the fields of imaging and minimally invasive care, I believe the answers to these issues are at hand.
In a major step forward was the publishing of the results of PROMIS (Ahmed, The Lancet 2017) comparing the results of using Multiparametric MRI (mpMRI) targeting of prostate cancer Index Lesions to standard, template driven ultrasound guided prostate biopsies and found that MRI targeting can
- Find far more “significant” and far fewer “insignificant” prostate cancers than ultrasound guided biopsies.
- Safely avoid 27% of men from receiving biopsies if the mpMRI was negative.
Furthermore, Panebianco demonstrated that ZERO of 130 men with negative MRI had any evidence of Gleason Pattern 4 cancer after saturation biopsy of the prostate gland (Urological Oncology 2014).
I first began using Focal Cryoablation in 2011 for a patient who had recurrent prostate cancer initially treated with radiation therapy. After special testing, and in particular mpMRI, his recurrence was isolated to his prostate gland. I was able to complete ablate this cancer and his serum PSA remains undetectable six years later. Since then, I have treated scores of men presenting with significant, targeted prostate cancer lesions with great success.
Although other ablation modalities are emerging, such as High Frequency Ultrasound or “HiFu” the distinct advantages of Cryoablation include:
- High certainty of target cell death
- Excellent capacity to monitor therapy in real time
- Quickly performed via transperineal approach
- Ability to monitor and protect External Sphincter and Neurovascular bundles
- Covered by Medicare and most Private Insurance
- Excellent near and mid-term efficacy
- Ability to be repeated for new lesions, if necessary