BLOGGERS: MARK SCHOLZ, MD & RALPH H. BLUM

The co-authors of Invasion of the Prostate Snatchers, blog alternate posts weekly. We invite you to post your comments.
Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts

Tuesday, January 26, 2016

Crila, A Solution to Old Men’s Urinary Problems?

BY MARK SCHOLZ, MD

As we get older, we run into all kinds of difficulties.  Poor hearing, sexual dysfunction, memory problems and arthritic joints, just to name a few. Bladder issues in particular can be troublesome, interrupting sleep, making us dread long drives or forcing us to visit the bathroom at an inopportune time.
As a prostate oncologist taking care of many men who are in their 60s and 70s, it’s no surprise that I hear a lot about urinary difficulties. These problems are often thought to result from prostate enlargement, otherwise known as BPH. The swollen gland ends up pinching the urinary passage way (called the urethra).  Slow urination and incomplete emptying of the bladder are the result. 
Prostate gland enlargement with incomplete bladder emptying can frequently be solved with common prescription medications like Flomax, Rapaflo and Uroxatrol which relax the muscles in the wall of the urethra and help to open up the passageway.  Proscar and Avodart can shrink the prostate but they also tend to shrink your libido. The most popular treatment is a nonprescription—Saw Palmetto an herbal product that works by relaxing the muscles in the urethra.
However, after doing thousands of color Doppler ultrasound examinations, which by the way is the most precise way to measure the size of the prostate, I have learned that BPH is a less common cause of men’s urinary problems. So what is the primary reason for men’s urinary frustrations? Prostatitis—low grade inflammation of the gland with secondary irritation. What causes prostatitis?  In a minority of cases it is due to bacterial infection. When this type of prostatitis occurs it may improve with antibiotics. But for the vast majority of cases we simply don’t know the cause.  Virus or autoimmune causes have been theorized but nothing has been proven. Our ignorance, however, has nothing to do with its prevalence. It is not widely realized, but almost all men have some degree of chronic inflammation in their prostate glands.
Though we don’t know the precise etiology, anti-inflammatory medications can be quite effective at alleviating the symptoms of prostatitis. Over the counter products like Aleve and Motrin are effective. Celebrex, is a prescription anti-inflammatory agent that is billed as having less stomach irritation. However, unless the pills are used continuously, the inflammation comes back.
Recently, I have been introduced to a natural anti-inflammatory substance discovered in the flower of the Crila plant. Several of our patients tried Crila with notable improvement to their urinary symptoms. So far we have not observed any side effects.  To investigate Crila’s effectiveness further, I have petitioned the manufacturer to provide a 3-month supply of Crila to 15 of our patients at no cost. Patients who have problems with frequent urination, a strong sense of urinary urgency or have to get up frequently at night to urinate may want to consider contacting Sabrina in our office about their eligibility for participating in this clinical trial. 

Tuesday, May 5, 2015

Oxygen Therapy: In the Absence of Evidence

BY RALPH BLUM

Since Mark and I published, Invasion of the Prostate Snatchers, I have been getting a surprising number of questions about the use of oxygen therapy as a vigorous anti-cancer technology. Based on all the inquiries one would think there must be evidence of a widespread belief that oxygen therapy acts to retard or even halt the spread of prostate cancer.

I regret to say that, as of this writing, that is almost entirely untrue, or at best, unproven, except in one situation: Hyperbaric treatment is used to accelerate healing of tissue damaged by radiation therapy. Available scientific evidence does not support claims that increasing oxygen levels in the body will kill or even inhibit the growth of cancer cells.

How is Oxygen Therapy Promoted for Use?
Different varieties of oxygen therapy are effective for treating multiple conditions, including carbon monoxide poisoning, certain kinds of wounds, injuries and skin infections, delayed radiation injury and certain bone and brain infections. However, the FDA sent a warning letter to at least one manufacturer about promoting  oxygen treatment for unproven uses such as certain types of cancer, asthma, emphysema, AIDS, arthritis, heart and vascular diseases, multiple sclerosis and Alzheimer’s disease.

Proponents of oxygen therapy claim that cancer cells thrive in low-oxygen environments. They believe adding oxygen to the body creates an oxygen-rich condition in which cancer cells cannot survive. They also claim that a high oxygen environment increases the efficiency of all cells in the body, increases energy, promotes the production of antioxidants and enhances immune system function.

Other oxygen aficionados believe that immersing an affected body part can cause tumors to separate from the body so that a cancer can be “wiped away.” There is little evidence that this is the case. And yet, a considerable number of men are committing to a variety of oxygen treatments. And that concerns me. So I will give you a brief survey of the oxygen therapy field.

What is the History of Oxygen Therapy?
The history of putting oxygen-releasing substances into the body follows several tracks. Interest in ozone dates back to the mid-1800s in Germany, where it was claimed to purify blood. During World War I, doctors used ozone to treat wounds, trench foot and the effects of poison gas. In the 1920s, ozone and hydrogen peroxide were used experimentally to treat the flu.

One of the earliest accounts of the medical use of hydrogen peroxide was a short article by I.N. Love, MD, in 1888 in the Journal of the American Medical Association. Dr. Love recommended using hydrogen peroxide as “a stimulator of healing." Unlike most current articles, the 1888 report in that prestigious journal did not include details that would be required today, such as whether patients treated with peroxide lived longer than those receiving placebo, or whether there was any solid evidence that peroxide caused cancers to shrink or disappear.

During the 1930s, Otto Warburg, MD, a winner of the Nobel Prize in 1931 for his research on respiratory enzymes, discovered that cancer cells have a lower chemical respiration rate than normal cells. He reasoned that cancer cells thrived in a low-oxygen environment and that increased oxygen levels might therefore harm and even kill them. Many of the beliefs held by oxygen therapy proponents are based on Dr. Warburg’s theories concerning cancer, even though technical advances have since offered a great deal more information about how cancer cells really use oxygen.

Negative Reviews
According to Dr. Stephen Barrett, who writes about health fraud, reviewed a researcher from the Dominican Republic who claimed that his clinic used ozone gas to cure thirteen people with cancer. An investigative news group later learned that two of the patients died of cancer, three could not be found, two refused to be interviewed, three were alive but still had cancer, and in three cases it was not clear if the patients actually ever had cancer.

Furthermore, a 1993 review article found some evidence that too much oxygen in the body’s tissues may damage genetic material and promote abnormal growth. And a 2001 review of ozone therapy concluded that "… few rigorous clinical trials of the treatment exist. Those that have been published demonstrated no evidence of effect . . . Until more positive evidence emerges, ozone therapy should be avoided."

Conclusion
Although oxygen therapy has its benefits, it is the subject of a great deal of controversy, and I could not find credible evidence that it either halts or slows cancer growth. Nor does depriving tumors of oxygen stimulate their growth.  Nevertheless, oxygen therapies continue to be widely promoted as alternative treatment for cancer and other serious illnesses, and are offered at clinics in Mexico, the United States and Europe. These clinics are attracting men with prostate cancer, men hopeful that the therapies provided will benefit them.

The lack of randomized clinical trials makes it difficult to judge the value of oxygen therapy for many of its claims, and we need to expand our knowledge on the effect and mechanisms behind tumor oxygenation.  Meanwhile it continues to be big business south of the border.

But let the buyer beware.

Tuesday, December 24, 2013

Merry Christmas and Happy New Year!

We're taking the holidays to gear up for 2014. We'll be back on 7 January. Here is a recap of the 2013 year in review - new social media launches.

THE PROSTATE VANGUARD  An email list for those interested in Active Surveillance and Imaging.  Learn more about it from Dr. Scholz http://www.youtube.com/watch?v=3c8lZPyOv04  and you may subscribe here: http://www.prostateoncology.com/contact/subscribe

KEEP MY PROSTATE  Stay tuned for a new web site launch in 2014
http://www.keepmyprostate.com/

GOOGLE+ DR. SCHOLZ and PROSTATE ONCOLOGY  Keep up on local events and news
google.com/+Prostateoncology
 
GOOGLE+ HANGOUTS with Prostate Cancer Live discussing The Overtreatment of Prostate Cancer https://plus.google.com/#s/%23hangoutsonair
 
CLINICAL TRIALS Current trials open for recruitment at Prostate Oncology Specialists
 
Wishing you and your loved ones a wonderful holiday season.

Tuesday, July 16, 2013

Combination Immune Therapy—A Major Breakthrough

BY MARK SCHOLZ, MD

Normally it’s a rule for me in these blogs to avoid straying away from the theme of prostate cancer. I want my efforts to have a practical application for those struggling with this condition.  After all, prostate cancer is my specialty.
 
However, I am going to make a rare exception and break with my usual policy because of a stunning medical breakthrough in the treatment of advanced metastatic melanoma, a very deadly condition that until recently has been totally resistant to all forms of treatment.  The only exception has been a newly FDA-approved immunotherapy called Yervoy.
 
A month ago I wrote about the high hopes we have for immune therapy for prostate cancer.  I also wrote about a clinical trial we are conducting at Prostate Oncology Specialists that evaluates the combination of two different types of immune treatment, Provenge and Yervoy (see my blogs from March and April of this year for further details).
 
Immune therapy has tremendous potential for treating cancer since the immune system has unlimited potential to adapt to any cancer scenario.  As more and more new types of immune therapy are being discovered, it’s only logical to conduct clinical trials that combine them to see if the simultaneous use of two immune treatments will further enhance the anticancer effect.
 
The report I am so excited about was just published in the New England Journal ofMedicine (NEJM). Doctors from Memorial Sloan Kettering and from Yale evaluated the combination of two types of immune therapy in advanced melanoma—Ipilimumab (Yervoy) and Nivolumab.  In my previous blog I explained how Yervoy functions by taking the “brakes” off the immune system.  Nivolumab works in a similar fashion, but works on a different set of brakes.  (It turns out that the immune system has two separate brake systems).
 
While Yervoy by itself has already been shown to be effective for treating melanoma and is FDA approved for this purpose, Nivolumab is still going through clinical trials. Twelve weeks after the researchers administered Yervoy and Nivolumab simultaneously, one third of the patients had more than an 80% regression of all known tumors.
 
Furthermore, the side effects of giving the medicines in combination were no more severe than those encountered when either of the drugs was used by itself.
 
This report from the NEJM is very exciting because it provides proof for the concept that combining immune treatments will lead to enhanced anticancer effects. Moreover, another report of success using a combination of immune treatments was just released at the annual meeting of the American Society of Clinical Oncology (ASCO). Two-hundred and forty-five men with melanoma were treated either with Yervoy alone or with a combination of Yervoy plus Leukine.  The men treated with the combination of Yervoy plus Leukine lived 30% longer!
 
Leukine is an immune system stimulating medication that the FDA approved years ago for increasing white blood cell counts in patients treated with chemotherapy.  However, Leukine is also known to have anticancer effects as well. For example, it is used as an integral component in Provenge.  In addition, at the ASCO meeting in 2011, we published results from a trial we did in Marina del Rey in prostate cancer patients showing that Leukine plus low-dose cyclophosphamide (another immune-modulating drug) delays prostate cancer progression.
 
My dear friends and patients, I am amazed at how rapidly immunotherapy is progressing.  Not only are new and exciting medications being discovered,  innovative research evaluating combinations of these new powerful new medicines is leading to stunning cancer reversals in cases that as recently as a couple years ago were deemed totally hopeless.
 
Let me leave you with this final and encouraging thought.  The immune system is very egalitarian. Great results achieved in one type of cancer will inevitably translate into effective treatments for other types of cancer as well, including, of course, prostate cancer. The achievement of unprecedented anticancer effects with combination immune therapy in a stubborn and deadly cancer like melanoma bodes very well for significant breakthroughs to occur for prostate cancer as well. 

Tuesday, January 1, 2013

Happy New Year Announcement from Prostate Oncology Specialists


Jeffrey Turner, MD, Medical Oncologist, Joins Prostate Oncology Specialists in Marina del Rey, CA.
MARINA DEL REY, Ca., December 31, 2012 - Prostate Oncology Specialists is pleased to announce that Jeffrey Turner, MD has joined the prostate cancer specialist team. Dr. Turner is a board-certified internist and medical oncologist and will be specializing exclusively in prostate cancer with Mark Scholz and Richard Lam. Dr. Turner has been specializing in prostate cancer since 2009. He graduated cum laude from USC. Thereafter, he worked in research at UCLA studying infectious disease and molecular biology.  He earned his medical degree in Canada at Memorial University of Newfoundland and completed his internal medicine residency at the University of British Columbia and fellowship in medical oncology at the Medical University of South Carolina. Dr. Turner has published several articles on urologic cancers with an emphasis on prostate cancer.  He is a sub-investigator of a number of ongoing prostate cancer clinical trials.

Dr. Mark Scholz, Medical Director of Prostate Oncology Specialists commented, “Dr. Turner joins us during a time when the number of new prostate cancer treatments is exploding. He will add his expertise and knowledge to help patients make informed decisions. In 2012, we conducted clinical trials with Zytiga and Xtandi, agents that are now FDA approved.  We are presently evaluating new agents such as Curstersin, XL-184 and Ipilimumab in combination with Provenge.  We are happy to welcome a talented new member to the team who is familiar with all the many new treatment options for patients—this also includes Active Surveillance which is rapidly gaining acceptance as a viable treatment for prostate cancer.”
Active Surveillance remains very popular given the alternative risk of permanent side-effects from surgery, radiation, or cryotherapy. Dr. Turner added, “With the dramatic evolution of today's imaging techniques (including color Doppler ultrasound and MRI), Active Surveillance is best for men with Gleason 6, PSA<10, and clinical stage less than or equal to T2a.  Due to the fact that men with Gleason 6 prostate cancer have an incredibly low risk of mortality, Active Surveillance should remain a strong alternative.”
As skilled leaders in treating prostate cancer, our medical oncologists use PSA monitoring and color Doppler scanning to accurately monitor men on Active Surveillance. These techniques can detect early disease progression in men who may need to pursue treatment intervention.  

For more information about Active Surveillance or Prostate Oncology Specialists - visit: www.keepmyprostate.com or www.prostateoncology.com/activesurveillance