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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Genomic Profile Can Improve Confidence in Active Surveillance of Prostate Cancer

MedicalResearch.com Interview with:

Bela S. Denes, MD, FACS Senior Director Medical Affairs UROLOGY Genomic Health Inc. Redwood City, CA. 94063

Dr. Bela S. Denes

Bela S. Denes, MD, FACS
Senior Director Medical Affairs
UROLOGY
Genomic Health Inc.
Redwood City, CA. 94063

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

Response: This is a prospective community based non-interventional study designed to provide information on the utility of Oncotype GPS in the management of men presenting with a new diagnosis of clinically localized low risk prostate cancer. We sought to understand the impact of incorporating a molecular marker into the shared treatment decision in practices already well versed in Active Surveillance (AS) as measured by persistence on surveillance at 2 years as well as a number of patient reported outcomes. The current publication reports on the results of a one year pre-specified interim analysis.

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Malignancies More Common In Men With BRCA Germline Mutations

MedicalResearch.com Interview with:
Roy Mano, MD and
David Margel, MD, PhD
Department of Urology, Rabin Medical Center
Petach Tikva, Israel

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

Response: According to previous reports, male BRCA mutation carriers have a higher risk of developing malignancies of the prostate, pancreas, breast, colon and melanoma. While malignancy screening protocols for female BRCA carriers are well established and widely implemented, little is known about the optimal screening protocol for male BRCA carriers, and current screening protocols focus on malignancies of the breast and prostate rather than offer a comprehensive screening protocol for all BRCA associated malignancies.

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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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Flibanserin- Addyi -Improved Sexual Health in Women With Hypoactive Sexual Desire Disorder

MedicalResearch.com Interview with:

Dr. Michael Krychman, MD Executive Director: The Southern California Center for Sexual Health and Survivorship, Medical Director: Sexual Medicine at Hoag Hospital Newport Beach CA Clinical faculty member University of Southern California Los Angeles, CA

Dr. Krychman

Dr. Michael Krychman, MD
Executive Director: The Southern California Center for Sexual Health and Survivorship,
Medical Director: Sexual Medicine at Hoag Hospital Newport Beach CA
Clinical faculty member
University of Southern California
Los Angeles, CA

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

Response: This post hoc analysis pooled data from three 24-week, double-blind, placebo-controlled studies (VIOLET, DAISY, and BEGONIA) of flibanserin in premenopausal women with acquired, generalized HSDD5-7. Patients who received flibanserin 100 mg once daily at bedtime (qhs) or placebo were included in the analysis. The Female Sexual Function Index (FSFI) consists of 19 items across 6 domains. Scores range from 2 to 36. Higher scores indicate better sexual functioning. Scores under 26 indicate sexual dysfunction. Analysis of covariance was used to evaluate changes from the first week to week 24 in the FSFI domain and total scores were compared for flibanserin 100 mg qhs versus placebo. For patients who discontinued study participation prior to week 24, the last postbaseline observation was carried forward (LOCF).

Results found that treatment with flibanserin 100 mg qhs produced statistically significant improvement, relative to placebo, on all domains of the FSFI (desire, arousal, lubrication, orgasm, satisfaction and pain) in premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).

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E-cigarette Smoke Increases Bladder Cancer Risk

MedicalResearch.com Interview with:

Moon-shong Tang, Ph</strong>D Professor of Environmental Medicine, Pathology and Medicine New York University School of Medicine Tuxedo Park, New York 10987

Dr. Moon-shong Tang

Moon-shong Tang, PhD
Professor of Environmental Medicine, Pathology and Medicine
New York University Langone School of Medicine
Tuxedo Park, New York 10987

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

Response: E-cigarettes (E-cigs) are designed to deliver the stimulant nicotine through aerosols, commonly referred as vapors. Nicotine is dissolved in organic solvents such as glycerin and propylene glycol. The nicotine is then aerosolized by controlled electric heating. E-cigs do not use tobacco leaves and E-cig smoke does not involve the burning process. Hence, E-cig smoke (ECS) contains only nicotine and the gas phase of the solvent. Because ECS contains neither carcinogens nor allergens or odors from the tobacco burning process, E-cigs have been promoted as an invention that can deliver a TS ‘high’ without TS negative effects. The population of E-cig users is rapidly rising, particularly in young adults. It has been estimated that 16% of high school students are E-cig smokers. Therefore, the health effects of E-cig smoke, particularly its carcinogenicity, deserve careful scrutiny.

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Active Surveillance Can Be Expanded To Select Group of Younger Men With Prostate Cancer

MedicalResearch.com Interview with:

Keyan Salari, MD, PhD Resident in Urologic Surgery Keyan Salari is currently completing his residency in the Harvard Program in Urologic Surgery at the Massachusetts General Hospital, and is conducting post-doctoral research in cancer genomics in the Garraway Lab at the Dana-Farber Cancer Institute and the Broad Institute of Harvard and MI

Dr. Keyan Salari

Keyan Salari, MD, PhD
Resident in Urologic Surgery
Keyan Salari is currently completing his residency in the Harvard Program in Urologic Surgery at the Massachusetts General Hospital, and is conducting post-doctoral research in cancer genomics in the
Garraway Lab at the Dana-Farber Cancer Institute
and the Broad Institute of Harvard and MIT

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

Response: Active surveillance is an effective strategy addressing the problem of over treatment of clinically indolent prostate cancer, but data on the role of active surveillance in younger men is limited. Younger men diagnosed with prostate cancer are typically counseled to undergo treatment as opposed to surveillance of their prostate cancer.

To potentially expand the role of active surveillance to younger patient populations, we undertook this study evaluating the outcomes of younger men under 60 years of age who elected to pursue active surveillance of their prostate cancer.

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New Prostate Cancer Specific Assay May Reduce Need For Biopsies

MedicalResearch.com Interview with:

Eric A. Klein, MD</strong> Chairman, Glickman Urological and Kidney Institute Cleveland Clinic

Dr. Klein

Eric A. Klein, MD
Chairman, Glickman Urological and Kidney Institute
Cleveland Clinic

MedicalResearch.com: Which of these results did you find most interesting or surprising?

Response: What’s most interesting is that the IsoPSA assay redefines how PSA is measured, which links it more closely to the underlying biology of cancer. Current assays measure only the concentration of PSA, which can be affected by conditions other than cancer – BPH most commonly, but also infection and inflammation – which limits its diagnostic accuracy for finding cancer. Its been known for several decades that PSA exists in multiple different forms in the bloodstream in patients with prostate cancer.

These novel molecules arise because cancer cells have deranged cellular metabolism that result in the generation of new species of PSA, making their measurement more tightly linked to the presence or absence of cancer and even the presence of high grade cancer (where cellular metabolism is even more disordered).

The IsoPSA assay is the first assay to measure all of these isoforms and thus has better diagnostic accuracy for cancer.

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Psychiatric Side Effects of 5 Alpha Reductase Inhibitors for BPH

MedicalResearch.com Interview with:

Blayne Welk, MD, FRCSC Assistant Professor of Surgery Western University

Dr. Blayne Welk

Blayne Welk, MD, FRCSC
Assistant Professor of Surgery
Western University

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

Response: Concerns have been raised by regulatory agencies and patients about possible serious psychiatric side effects associated with the use of 5 alpha reductase inhibitors. These medications can be used for both enlarged prostates and alopecia.

We used administrative data to assess for potential psychiatric side effects associated with finasteride and dutasteride usage in older men with benign prostatic enlargement.

In our study we found that there was no increased risk of suicide associated with the use of these medications. However, there was a small increase in both self-harm and new onset depression associated with the use of 5 alpha reductase inhibitors.
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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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Clinical Outcomes Following a Low-Suspicion MRI for Prostate Cancer

MedicalResearch.com Interview with:

Lars Boesen MD PhD Department of Urology Herlev Gentofte University Hospital Herlev

Dr. Boessen

Lars Boesen MD PhD
Department of Urology
Herlev Gentofte University Hospital
Herlev

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

Response: Transrectal ultrasound-guided biopsies (TRUS-bx) traditionally used for detecting prostate cancer (PCa) are prone to sampling errors due to difficulties in target identification. Therefore, concerns about the possibility of missing significant prostate cancer result in men with negative biopsy results frequently undergo repeated biopsies, leading to increased medical costs, patient anxiety and morbidity.

Multiparametric MRI (mp-MRI) has become increasingly important in prostate cancer diagnosis. A suspicious lesion can be targeted by MRI-guided biopsies and improve diagnosis. Conversely, a normal mp-MRI may non-invasively exclude the possibility of an aggressive disease, avoiding the need for further biopsies. However, there are no current guidelines for clinicians whether standard repeated biopsies (TRUS-bx) should be performed in men with either a low-suspicion mp-MRI or benign MRI-targeted biopsies of a suspicious lesion and the clinical outcome and future risk of detecting significant prostate cancer following these findings is unknown.

Therefore, we assessed the risk of being diagnosed with prostate cancer after either a low-suspicion mp-MRI or benign targeted biopsies of a suspicious lesion in men with prior negative TRUS-bx, but a persistent clinical suspicion of missed significant cancer over a follow-up period of at least three years. Our results suggest that a low-suspicion MRI in men with prior negative TRUS-bx can be used non-invasively in ruling out longer term significant cancer and immediate repeated biopsies are of limited clinical value and might be avoided even if prostate-specific-antigen levels are persistently elevated.

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

Response: A low-suspicion mp-MRI in a man with prior negative TRUS-bx has a high accuracy in ruling out a significant aggressive prostate cancer during follow-up of at least three years. Thus, immediate repeated biopsies rarely find significant disease and could be avoided even if the prostate-specific-antigen level is persistently elevated.

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

Response: Our results should be verified in larger prospective studies with a longer follow-up period to assess other clinical endpoints that include disease progression, cancer specific mortality and associated costs with an mp-MRI approach.

There are no disclosures or conflicts of interest

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

Citation:
J Urol. 2017 Feb 21. pii: S0022-5347(17)30297-5. doi: 10.1016/j.juro.2017.02.073. [Epub ahead of print]
Clinical outcome following a low-suspicion multiparametric prostate MRI or benign MRI-guided biopsy to detect prostate cancer: A follow-up study in men with prior negative transrectal ultrasound-guided biopsies.
Boesen L1, Nørgaard N2, Løgager V3, Thomsen HS4.
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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Penile Length One Year After Radical Prostatectomy Not Statistically Different Than Pre-Op

MedicalResearch.com Interview with:
Yoshifumi Kadono, MD. PhD.
Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science,
Kanazawa, Ishikawa, Japan 

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

Response: I had experienced some patients who underwent radical prostatectomy (RP) complained penile shortening after RP. Once I checked that kind of reports, some reports mentioned the phenomenon of penile shortening (PS) after radical prostatectomy; however, the results were little bit different and the reasons of PS after RP were not well elucidated.

Therefore, we started our study to obtain our data. In our study, the penile length (PL) was measured before, 10 days after, and at 1, 3, 6, 9, 12, 18, and 24 months after RP. And the PL at 10 days after RP was shortest, and it gradually recovered thereafter. Penile length at 12 months after radical prostatectomy was not significantly different from preoperative penile length. Based on MRI investigation, slight vertical repositioning of the membranous urethra after radical prostatectomy caused chronological changes in penile length.

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