Archive | August, 2011

Provenge is Now Covered by Medicare

Patrick Conway, MD, Centers for Medicare and Medicaid Services (CMS) chief medical officer has announced that Medicare will pay for the expensive immunotherapeutic agent sipuleucel-T (Provenge) for the treatment of advanced castrate resistant prostate cancer treatment.  CMS has determined that the drug is effective in metastatic hormone-refractory disease, and it had previously proposed to pay for treatment for Medicare beneficiaries, but it needed to collect and evaluate public comments.    Medicare will cover the expenses for men for whom prostate cancer is at an advanced stage and for whom the cancer does not respond to radiation or hormone therapy.

Treatment with Provenge requires a multi-day regimen during which the patient’s white blood cells are collected and exposed to proteins that direct the white blood cells to fight prostate cancer cells.  The cells, which then become primed to recognize tumor cells and direct an immune-system attack on them, are then returned to the patient. These patients receive a total of three treatments.

The FDA approved Provenge in April 2010.  The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) found that the treatment, with a score of 3.7 out of 5, significantly improved survical in patients with metastatic hormone-refractory prostate cancer.  Provenge, which is made by Dendreon Corp., is estimated to cost about $93,000 per patient.

Dr. Conway has announced that CMS will only cover indications supported by the label, which stipulates that Provenge is for patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.  He urges patients to discuss the risks and benefits with their physicians before making the decision to use Provenge.

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Alternative Procedure is Available for Treating Enlarged Prostate

According to Dr. Joao Martins Pisco, lead author of a study presented on March 29, 2011 at the annual meeting of the Society of Interventional Radiology in Chicago, a new treatment called prostatic artery embolization (PAE) may be used in certain patients with prostates larger than 60 cubic centimeters and who have serious lower urinary tract symptoms and weakened urinary stream.

Enlarged prostate, also known as benign prostate hyperplasia, is a non-cancerous condition that affects millions of aging men.  This condition occurs when the prostate gland slowly enlarges and presses on the uretha, which constricts the flow of urine.  It is characterized by unpleasant symptoms including a weak or slow urine flow, a constant and urgent need to urinate, not being able to fully empty the bladder, and having to get up repeatedly at night to urinate.

The surgery that has generally been used to treat enlarged prostate, transurethral resection of the prostate (TURP), is used for men whose prostates are smaller than 60 to 80 cubic centimeters.  The procedure requires general anesthesia and a hospital stay.

In contrast, there is no size limitation for PAE, which requires only local anesthesia.  Researchers say that the procedure lowers the risk of other side effects including blood loss and retrograde ejaculation, which happens when semen leaks into the bladder.  PAE can also be an outpatient procedure.

According to the study, PAE helped the majority of 67 patients who received the treatment.  Sixty-six of the men who had not responded to medications experienced improvements in symptoms and a reduction in prostate volume.  After nine months, none of these men experienced sexual dysfunction, and a quarter continued to report improvements.

PAE, however, remains controversial and few doctors are trained in this procedure.  Authors of the study reported that there was not a great an improvement in improved flow rate of urine in patients who underwent PAE, which would indicate the performance of the bladder and urethra, as those who underwent TURP.

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New Findings Show that Prostate Cancer Can Adapt to Survive Hormone Therapy

A recent study at UCLA’s Jonsson Comprehensive Cancer Center, researchers found that when a common type of prostate cancer was treated with conventional hormone ablation therapy that blocks androgen production or androgen receptor (AR) function, which increases the growth of the tumor, the cancer was able to adapt to this treatment by activating a survival cell pathway.  This particular type of prostate cancer, in which the PTEN tumor suppressor gene is inactivated, accounts for about 40 to 50 percent of primary prostate cancers and 70 to 90 percent of cancers that become resistant to hormone therapy, also known as castration-resistant prostate cancers.  According to Hong Wu, M.D., Ph.D., the study’s senior author, these prostate cancers could be more effectively treated using a combination of drugs that target the AR cell signaling pathway and the adapted survival pathway.

According to Wu, the discovery goes against conventional wisdom about the way PTEN negative or PTEN null prostate cancer operates.  Previously, most hypotheses suggested that PTEN regulates the function of the androgen receptor pathway, which turns out to be the opposite of the study’s findings.  The findings of this study were thus surprising in showing that PTEN loss represses AR signaling and causes cancer cells to become less dependent on the AR for survival.  According to David J. Mulholland, a postdoctoral fellow in Wu’s lab and first author of the study, it has important implications for prostate patients with late stage disease, who often become resistant to hormone ablation therapy.  The men who die of prostate cancer are the ones who become resistant to therapy and, as a result, the cancer spreads or metastasizes to other places, usually to the bones.

The five-year study was first modeled in a mouse model created at Wu’s laboratory in which PTEN and AR are absent in the epithelium.  The team then replicated the findings using samples from cancerous prostates removed from patients, which was done in coloration with researchers at UCLA and the Specialized Program of Research Excellence (SPORE) in prostate cancer.  They found similar results in both bases.  The study was funded by the National Institutes of Health, the Department of Defense, the Prostate Cancer Foundation, the California Institute for Regenerative Medicine and Jean Perkins Foundation.

Over 217,000 American men will be diagnosed with prostate cancer this year, out of which 32,000 will die.

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Dallas Urologist Develops HIdES Technique to Minimize Kidney Surgery Scarring in Children and Young Adults

Patricio Gargollo, M.D., a urologist at UT Southwestern Medical Center in Dallas, has developed a minimally invasive procedure to eliminate scarring in kidney surgeries on his pediatric patients.  This new technique, which is just as effective as more common surgical techniques such as laparoscopy, is called hidden incision endoscopic surgery (HIdES).  A working port, a camera port, and a 5mm assistant port are place below the line of incision, and a second working port is placed close to the bellybutton.  This technique allows patients to hide their scars under a bathing suit and below the bikini line.  HIdES won the Best New Technique Award from the International Robotic Urology Symposium in 2010.

Gargollo has used this procedure for 18 cases in 17 patients between April and July 2010, and none of the patients experienced any complications.  Ages of the patients ranged from 3 to 20 years old, and the average age was 10 years old.

A recent study in the Journal of Urology reported that twelve patients and their parents who were asked to answer three questionnaires were more satisfied with the cosmetic appearance of incision scars left by HIdES than by laparascopic or open surgery.  These results were statistically significant.

Broader implications for this technique are that it may be applied to surgery on other parts of the body, including upper abdominal and some pelvic surgeries.  Gargollo reports the technique as being simple and easier to learn than techniques involving laparascopic surgery, which leads to small but visible scars.

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