MRI Guided Prostate Biopsies Can Improve Care and Reduce Costs

MedicalResearch.com Interview with:

Vikas Gulani, MD, PhD Director, MRI, UH Cleveland Medical Center Associate Professor, Radiology, CWRU School of Medicine

Dr. Gulani

Vikas Gulani, MD, PhD
Director, MRI, UH Cleveland Medical Center
Associate Professor, Radiology, CWRU School of Medicine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We wanted to learn if performing MR before prostate biopsy, followed by MR guided strategies for biopsy, are cost effective for the diagnosis of prostate cancer in men who have not previously undergone a biopsy and who have a suspicion of prostate cancer.

The most significant findings are as follows:

We found that all three MR guided strategies for lesion targeting (cognitive targeting, MR-ultrasound fusion targeting, and in-gantry targeting) are cost effective, as the increase in net health benefits as measured by addition of quality adjusted life years (QALY), outweigh the additional costs according to commonly accepted willingness to pay thresholds in the United States.

Cognitive targeting was the most cost effective. In-gantry biopsy added the most health benefit, and this additional benefit was cost-effective as well.

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Minimally Invasive Rezum® Radiofrequency System Treats Obese Men With Lower Urinary Tract Symptoms Caused by BPH


MedicalResearch.com Interview with:
Dr. Nikhil K. Gupta
and
Kevin McVary, MD, FACS
Professor, Department of Surgery
Chair, Division of Urology
Southern Illinois University School of Medicine

MedicalResearch.com: What is the background for this study?

Pre Treatment.jpg: Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland, affecting 12 million men in the U.S., with nearly 800,000 newly diagnosed each year. An enlarged prostate squeezes down on the urethra causing lower urinary tract symptoms.

Pre Treatment.jpg: Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland, affecting 12 million men in the U.S., with nearly 800,000 newly diagnosed each year. An enlarged prostate squeezes down on the urethra causing lower urinary tract symptoms.

Response: Male lower urinary tract symptoms due to benign prostatic hyperplasia, or LUTS due to BPH, have most commonly been treated with a combination of medication, such as alpha-blockers and 5-alpha reductase inhibitors, and surgery, such as transurethral resection of prostate (TURP) and Greenlight photovaporization of prostate (PVP). These treatments, however, have potentially serious adverse and sexual side effects. Minimally invasive surgical therapies (MIST) for LUTS due to BPH have tried to thread the needle between medications and invasive surgery, giving effective relief of symptoms with minimal anesthetic need while preserving sexual function. Previously developed MISTs have been unable to provide durable relief of symptoms, causing patients to undergo multiple treatments in a short period of time, and have been limited by prostate size and conformation, e.g. the inability to treat a middle lobe or median bar. LUTS due to BPH is also very strongly and likely causally linked with obesity, and obesity seems to have an effect on the efficacy of treatment as well, as obesity affects response to medication and tends to dampen the treatment effect of TURP.

Convective Radiofrequency Water Vapor Energy ablation of the prostate, named Rezūm®, is a new MIST that uses radiofrequency to generate energy in the form of water vapor. The water vapor acts as a convective energy source and, once injected into the treatment area, distributes itself evenly within the treated tissue, causing uniform necrosis througout the treated area. This mechanism using convection is in contrast to previous technologies using conductive heat energy, which created a heat gradient with tissue closest to the heat source receiving the largest amount of energy and tissue farthest from the heat source receiving almost no energy. Thus conductive energy has a different effect on different parts of the treated area. With Rezūm, MRI studies have shown that the water vapor creates a uniform treatment effect while staying within collagen barriers, obeying natural tissue planes and affecting only the intended treatment areas.

The purpose of this study was to determine the efficacy of Rezūm in treatment of LUTS due to BPH, examine the treatment’s effect on sexual function, and to determine whether obesity affected treatment efficacy.

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Prostate Artery Embolization Is Less Invasive Choice For BPH Treatment

MedicalResearch.com Interview with:

Dr. João Martins Pisco, MD PhD Hospital St. Louis, International Prostate Medical Center Lisbon, Portugal

Dr. João Martins Pisco

Dr. João Martins Pisco, MD PhD
Hospital St. Louis, International Prostate Medical Center
Lisbon, Portugal

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Enlarged prostate, also known as benign prostatic hyperplasia (BPH), is one of the most common prostate problems occurring in men older than 50. According to the National Institutes of Health, as many as 14 million men in the U.S. had symptoms suggestive of BPH, which can affect 50 percent of men between 51 and 60 years of age and up to 90 percent of men older than 80. A few years ago, Dr. João Martins Pisco developed the minimally invasive treatment, known as prostate artery embolization, to treat BPH. The study that Dr. Pisco presented at the Society of Interventional Radiology on March 8 is the first of its kind – a study with 1,000 patients with long-term efficacy data.

Between March 2007 and March 2016, Dr. Pisco and his team performed PAE on 1,000 men who averaged 67 years of age. All patients were evaluated in the short term (one, three, and six months), 807 patients were seen through the medium term (every six months between six months and three years), and 406 patients were evaluated long term (every year after three years).

During each evaluation, the men’s symptoms were measured by the International Prostate Symptom Score (IPSS), which tests for the blockage of urine flow, and the International Index of Erectile Function (IIEF), which assesses erectile dysfunction. Researchers also measured the size of the prostate and the amount of urine left in the bladder after urination. They also evaluated the peak urinary flow rate and the prostate-specific antigen (PSA) level, a test used to screen for prostate cancer.

MedicalResearch.com:  What are the main findings?

Response:  The data from these measures revealed at the short-term mark that the treatment had an 89 percent cumulative success rate—measuring the success across all variables through the given testing period. The 807 men evaluated at the medium-term mark had an 82 percent success rate. And of the 406 patients measured at the long-term mark, 78 percent were considered cumulative successes.

In an additional analysis, researchers found that among 112 patients who also suffered acute urinary retention (AUR) before undergoing PAE, 106 or 94.6 percent had their catheter removed between two days and three months after treatment. At medium-term and long-term follow up, 95 of the 112 (84.8 percent) and 89 of the 112 (78.5 percent) did not experience any recurrence of their AUR.

The team also performed PAE in 210 patients who had limited treatment options due to extreme enlargement of the prostate (larger than 100 cm³). Of these men, 84 percent experienced cumulative success at short-term evaluation and 76.2 percent at medium- and long-term. The normal size of a prostate is 15 cm3 to 30 cm3.

MedicalResearch.com: What should readers take away from your report?

Response:  Prostate artery embolization gives men with BPH a treatment option that is less invasive than other therapies and allows them to return to their normal lives sooner. Time and time again, Dr. Pisco has seen patients who are relieved to find out about PAE because they are not able to tolerate medications for BPH due to their side effects. These men also don’t want traditional surgery because it involves greater risks, has possible sexual side effects, and has a recovery time that is relatively long compared to PAE, which is generally performed under local anesthesia and on an outpatient basis.

Prostate artery embolization should also be presented to patients who are exploring options to resolve their BPH.

That said, PAE may not be appropriate for all patients, such as those with advanced arterial atherosclerosis that may be due to smoking or diabetes. Patients should speak with an interventional radiologist or other members of their care team to discuss treatment options.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: As a next step, Dr. Pisco and his team are now conducting a study comparing the effectiveness of PAE to a sham – or placebo—treatment to address any possible placebo effect that may have occurred during Pisco’s research with these 1,000 patients.

MedicalResearch.com: Is there anything else you would like to add?

Response: Prostate artery embolization is a safe and effective treatment and these data demonstrate the efficacy of the therapy in the long term. It’s important that patients know about this therapy as they explore how to resolve their BPH. 

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Society of Interventional Radiology abstract discussing:

Prostate artery embolization for BPH

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Prostate Biopsies and Prostatectomies Drop After PSA Recommendation Changes

MedicalResearch.com Interview with:

Jim C. Hu, M.D., M.P.H. Ronald P. Lynch Professor of Urologic Oncology Director of the LeFrak Center for Robotic Surgery Weill Cornell Medicine Urology New York Presbyterian/Weill Cornell New York, NY 10065

Dr. Jim Hu

Jim C. Hu, M.D., M.P.H.
Ronald P. Lynch Professor of Urologic Oncology
Director of the LeFrak Center for Robotic Surgery
Weill Cornell Medicine
Urology
New York Presbyterian/Weill Cornell
New York, NY 10065

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The US Preventative Services Task Force (USPSTF) recommended against PSA testing in men older than 75 years in 2008 and more recently in all US men regardless of age in 2012. This was largely based on a faulty study, the prostate, lung, colo-rectal and ovarian screening study. We demonstrated in May 2016 that this randomized trial did not compare screening to no screening or apples to oranges, as it set out to do. It compared screening to screening. Although controversial, the guidelines were well-intentioned, as recognize that there is over-diagnosis and over-treatment of men with prostate cancer. Given this background, the goal of our study was to explore the downstream consequences of the recommendation against PSA screening. As such, we explored 3 separate databases to characterize national procedure volumes for prostate needle biopsy and radical prostatectomy, or surgery to cure prostate cancer.

The main finding was that prostate biopsy numbers decreased by 29% and radical prostatectomy surgeries decreased by 16% when comparing before to after USPSTF recommendations against PSA screening. Therefore practice patterns followed policy. Prostate biopsies are usually performed due to an elevated, abnormal screening PSA. However, it is also performed to monitor low-risk, slow growing prostate cancers. We also found that while the overall number of prostate biopsies decreased, there was a 29% increase in the proportion or percentage of biopsies performed due to active surveillance, or monitoring of low risk prostate cancers which should be done periodically. Therefore we provide the first national study to demonstrate that there is less over-diagnosis and over-treatment of prostate cancer.

However, the concern is that we also recently demonstrated that there is more aggressive prostate cancer on surgical pathology for men who go on to radical prostatectomy. They have high grade, higher stage cancers, which have a lower chance of cure. The link is:

http://www.prostatecancerreports.org/fulltext/2016/_Hu_JC160708.pdf

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Is Testosterone Therapy Safe in Patients with Treated and Untreated Prostate Cancer?

MedicalResearch.com Interview with:

Dr. Jesse Ory Department of Urology, Faculty of Medicine Dalhousie University, Halifax Nova Scotia, Canada

Dr. Jesse Ory

Dr. Jesse Ory
Department of Urology, Faculty of Medicine
Dalhousie University, Halifax
Nova Scotia, Canada 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The use of Testosterone Therapy (TT) in men diagnosed with and treated for prostate cancer (CaP) has been highly controversial for several decades. Unfortunately, this controversy is largely founded on the results of a single patient in a study by Huggins and Hodges in the 1940s [1]. This wasn’t challenged until recently, when Morgentaler reviewed the literature on the topic and found no scientific basis for the assumption that TT will act like fuel on the fire of prostate cancer [2]. He also proposed a mechanism, the “saturation hypothesis” that helps account for why TT may in fact be safe for men with prostate cancer. [3]. Over the past decade, retrospective evidence has been accumulating that supports the safety of Testosterone Therapy in hypogonadal men with CaP on Active Surveillance, or in those who have been definitively treated for prostate cancer..

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Digital Rectal Exam and PSA May Detect Distinct Subtypes of Prostate Cancer

MedicalResearch.com Interview with:

Jim C. Hu, MD Ronald Lynch Professor of Urologic Oncology Weill Cornell Medicine New York, NY 10065

Dr. Jim Hu

Jim C. Hu, MD
Ronald Lynch Professor of Urologic Oncology
Weill Cornell Medicine
New York, NY 10065

MedicalResearch.com: What is the background for this study?

Response: Initial results from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO), a large-scale randomized controlled trial of prostate cancer screening in the United States, radically changed the landscape of prostate cancer screening insofar as it led the United States Preventative Services Task Force (USPSTF) to recommend against routine screening with prostate-specific antigen (PSA). Though many subsequent studies have continued to investigate the role of PSA in screening, there is a paucity of data examining the use of digital rectal examination (DRE) for screening in the PSA era. Indeed, the USPSTF recommendation did not explicitly address DRE, calling for further research to evaluate the role of periodic DRE in prostate cancer screening. Likewise, while recent guidelines from the National Comprehensive Cancer Network (NCCN) recommend use of PSA in all men who elect screening, the role of digital rectal examination is equivocal.

We sought to evaluate the value of  digital rectal examination and PSA for detection of clinically significant prostate cancer and prostate cancer-specific (PCSM) and overall mortality in a secondary analysis of the PLCO.

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Prostate Cancer: Amended Gleason Score Underestimates Adverse Effect of Cribriform Pathology

MedicalResearch.com Interview with:

Kenneth A. Iczkowski, M.D. Department of Pathology Medical College of Wisconsin Milwaukee, WI 53226

Dr. Kenneth Iczkowski,

Kenneth A. Iczkowski, M.D.
Department of Pathology
Medical College of Wisconsin
Milwaukee, WI 53226

MedicalResearch.com: What is the background for this study?

Dr. Iczkowski: The International Society of Urological Pathology (ISUP) in 2014 proposed use of a new 5-tier grade grouping system to supplement traditional Gleason grading to facilitate prognosis stratification and treatment1. The 5 categories subsume: Gleason 3+3=6, Gleason 3+4=7, Gleason 4+3=7, Gleason 8, and Gleason 9-10.

We desired to determine whether men with a highest Gleason score of 3+5=8 or 5+3=8 in their set of prostate biopsy specimens, would have differing outcomes from those with Gleason 4+4=8. Because Gleason 5 cancer has been demonstrated to have a higher biologic potential than Gleason 4, it was expected that Gleason score 8 pattern with any Gleason 5 pattern would have a worse outcome.

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WAVE Therapy For Benign Prostatic Hyperplasia

MedicalResearch.com Interview with:

Kevin T. McVary, MD, FACS Chair, Division of Urology The Pavilion at St. John’s Hospital Springfield, IL

Dr. Kevin T. McVary

Kevin T. McVary, MD, FACS
Chair, Division of Urology
The Pavilion at St. John’s Hospital
Springfield, IL
Chair and Professor of Urology
SIU School of Medicine

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. McVary: Benign Prostatic Hyperplasia (BPH) is a localized enlargement of the prostate gland in aging adult men. It affects approximately 75% of men over the age of 65. This excess growth of tissue compresses and obstructs the urethra, reducing the flow of urine from the bladder and sometimes blocking it entirely. As the symptoms increase, they can greatly impact a man’s quality of life. Both BPH and the existing treatments for it can negatively affect an individual’s sex life.

The Rezūm II IDE pivotal study was a prospective, multicenter, randomized (2:1) controlled trial that enrolled 197 patients across 15 clinical sites in the U.S. The main finding showed that radiofrequency generated convective water vapor thermal therapy provides rapid and sustainable improvement of lower urinary tract symptoms (LUTS) secondary to BPH and urinary flow over a 12-month period without negative effects on erectile and ejaculatory function. These results support the application of convective water vapor energy (WAVE) technology as safe and effective minimally invasive therapeutic alternative for symptomatic BPH. Additionally, no treatment or device related de novo erectile dysfunction occurred after thermal therapy, ejaculatory bother score improved 31% over baseline, and 27% of subjects achieved minimal clinically important differences (MCIDs) in erectile function scores at 1 year, including those with moderate to severe ED.

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Does Testosterone Therapy Worsen Prostate Cancer Progression?

MedicalResearch.com Interview with:
Ryan Flannigan MD FRCSC
PGY 5 Urology Resident
Department of Urological Sciences
University of British Columbia

MedicalResearch.com: What is the background for this study?

Dr. Flannigan: In the aging population the incidence of both prostate cancer and testosterone deficiency (TD) increase and even overlap in many patients. However, since Huggins’ original research in 1940, we have understood that prostate cancer is largely regulated by the androgen receptor (AR). Thus, the thought of treating someone with exogenous testosterone (T) was concerning for fear of further activation of the androgen receptor, and therefore promoting prostate cancer growth. However, further research has continued to add clarity to this complex interaction between androgens and the prostate. The saturation theory describes the observation that prostate specific antigen (PSA) responds to increasing serum testosterone levels only to a value of approximately 8.7nmol/L, with no inflation of PSA beyond these T levels. This is likely not the whole story when it comes to the interaction of T and the prostate, but it does suggest the prostate may not experience changes in cellular function with serum testosterone beyond low levels. It is also understood that prostate cancer requires AR activation to grow but is not caused by AR activation. Thus, we hypothesized that among those with un-treated prostate cancer, ie. patients on active surveillance, would not experience changes in biochemical recurrence (BCR) or changes in disease progression. In addition, we hypothesized that patients with previously treated prostate cancer would not have viable prostate cancer cells and thus, PSA would not increase.

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Prostate Cancer Radiation Raises Risk of Colon and Bladder Cancers

MedicalResearch.com Interview with:

Robert Nam, MD, FRCSC Ajmera Family Chair in Urologic Oncology Professor of Surgery University of Toronto Head, Genitourinary Cancer Site Odette Cancer Centre Sunnybrook Health Sciences Centre Toronto, Ontario

Dr. Robert Nam

Robert Nam, MD, FRCSC
Ajmera Family Chair in Urologic Oncology
Professor of Surgery
University of Toronto
Head, Genitourinary Cancer Site
Odette Cancer Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario

MedicalResearch.com: What is the background for this study?

Response: Prostate cancer treatment is associated with a number of complications including erectile dysfunction and urinary incontinence. Two years ago, we published a paper examining other, previously undescribed complications. The most controversial finding was a significantly increased risk of secondary cancers among men treated with radiotherapy. We therefore wanted to assess this in a meta-analysis, examining all the research currently available on the topic.

MedicalResearch.com: What are the main findings?

Response: We found that, for patients with prostate cancer, radiotherapy treatment was associated with significantly increased rates of bladder cancer, colorectal cancer and rectal cancer. There wasn’t an increased risk for other cancers such as lung and blood system cancer. However, the absolute rates of these cancers remained low (1-4% of patients).

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