Sperling Prostate Center

What Does it Take to Design Studies to Evaluate Partial Gland Treatments?

The answer to the title question is, it takes collaboration and commitment among several parties who may not have identical interests. Nowhere is this truer than in the area of partial gland treatment for prostate cancer (PCa). After all, a mere 25-30 years ago, a subtotal PCa treatment was unthinkable. At that time, there were only three options for patients newly diagnosed with localized PCa:

  1. Radical prostatectomy (RP) – surgical removal of the whole gland and nearby lymph nodes
  2. Radiation therapy (RT) – irradiating the whole gland by external beam
  3. Watchful waiting (WW) – holding off on whole gland treatment but monitor using PSA tests and digital rectal exams.

Reviewing recent history

Since the mid-to-late 1990s, snowballing advances in technology and biology allowed pioneering physicians to treat less than the whole gland. Technologically, there were a) more informative imaging thanks to multiparametric MRI (mpMRI), and b) medical ablation devices to can target lethal heat or cold to tumors. Biological advances included a) evidence from surgical prostate specimens that not all PCa is multifocal, b) research evidence that insignificant PCa is not always life-threatening, c) lab analysis to understand the natural history of PCa cells, and d) genomic analysis to predict cancer cell behavior.

The early ablationists who presented their experience with partial gland treatments were met with much scorn and resistance. The American Urological Association’s staunch traditionalists scoffed at the new idea that roughly 1/3 of PCa cases were not multifocal, and accused the ablationists of being clinically irresponsible because they were leaving living PCa behind.

Meanwhile, growing patient awareness of partial gland treatment, with its reduced side effect profile, meant that more men were seeking out doctors who offered subtotal treatment. These men wanted a middle ground approach between whole gland treatment vs. WW (now Active Surveillance). They weren’t happy with risking their urinary and sexual quality of life, nor with psychologically feeling like PCa was like a ticking time bomb in their bodies.

Competing interests

About a million prostate biopsies are performed annually in the U.S., and over 190,000 new PCa cases are expected to be diagnosed in 2020.[i] While not all of them will seek immediate treatment, such a large group of cancer patients gets the attention of doctors, hospital corporations, academic centers, researchers, payors (private and public), device manufacturers, and the U.S. Food & Drug administration

Each has been impacted by the evolution of subtotal gland treatment, and each has a vested interest in patient outcomes. To put it bluntly, partial gland ablation was going up against costly robotic surgery and radiation therapies as an economic competitor.

Need for standards and large prospective studies

The practice of medicine is, by its nature, conservative. It’s difficult to sell The Establishment on change. When something is proven to be safe and effective for patient health, why reinvent the wheel? Still, the thirst for progress, for more effective minimal-to-noninvasive treatments, for better healthcare economy, and greater patient quality of life have driven the momentum toward partial gland ablations.

Now this forward movement has generated a need for standards, including ethics and manufacturing oversight, and scientific evidence that partial gland treatment is living up to its promise. It calls for “prospective, multi-center data collection and evaluation of novel medical devices and drug/device combinations for partial gland ablation.”[ii] Here is where the need for collaboration comes in.

Organizing collaboration

The cooperation shows up in the SPARED-CRN (Study of Prostate Ablation Related Energy Devices Coordinated Registry Network). Its founding members describe it as

a private-public partnership between academic and community urologists, the FDA (U.S. Food and Drug Administration), the Medical Device Epidemiology Network and device manufacturers to examine the safety and effectiveness of technologies for partial gland ablation in men with localized prostate cancer.[iii]

Its purpose is to amass a partial gland treatment data registry based on non-randomized single-arm prospective studies in which every patient receives the same treatment. It is hoped that this will shed light on appropriate patient selection, treatment planning and follow-up protocols. Ideally, it will also assist with objective evaluation of new medical devices, and drug/device combinations for partial gland ablation.

All of us at Sperling Prostate Center, where we offer MRI-guided focal laser ablation for prostate cancer tumors, know how important inter-profession collaboration is in order to achieve consistent excellence. We send our best wishes for the success of SPARED-CRN’s efforts now and in the years to come.

NOTE: This content is solely for purposes of information and does not substitute for diagnostic or medical advice. Talk to your doctor if you are experiencing pelvic pain, or have any other health concerns or questions of a personal medical nature.

[i] https://www.cancer.org/cancer/prostate-cancer/about/key-statistics
[ii] Gross MD, Sedrakyan A, Bianco FJ, Carroll PR et al. SPARED Collaboration: Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer. J Urol. 2019 Nov;202(5):952-958
[iii] Ibid.

 

About Dr. Dan Sperling

Dan Sperling, MD, DABR, is a board certified radiologist who is globally recognized as a leader in multiparametric MRI for the detection and diagnosis of a range of disease conditions. As Medical Director of the Sperling Prostate Center, Sperling Medical Group and Sperling Neurosurgery Associates, he and his team are on the leading edge of significant change in medical practice. He is the co-author of the new patient book Redefining Prostate Cancer, and is a contributing author on over 25 published studies. For more information, contact the Sperling Prostate Center.

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