Archive | May, 2011

FDA approves Zytiga for Late-stage Prostate Cancer

The U.S. Food and Drug Administration today approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).

In prostate cancer, the male sex hormone testosterone stimulates prostate tumors to grow. Drugs or surgery are used to reduce testosterone production or to block testosterone’s effects. However, sometimes prostate cancer can continue to grow even when testosterone levels are low. Men with these cancers are said to have castration-resistant prostate cancer.

Zytiga is a pill that targets a protein called cytochrome P450 17A1 (CYP17A1) which plays an important role in the production of testosterone. The drug works by decreasing the production of this hormone that would stimulate cancer cells to continue growing.

The application was reviewed under the FDA’s priority review program, which provides for an expedited six-month review for drugs that may offer major advances in treatment, or provide a treatment when no adequate therapy exists. Zytiga is being approved ahead of the product’s June 20, 2011 regulatory goal date.

“Zytiga prolonged the lives of men with late-stage prostate cancer who had received prior treatments and had few available therapeutic options,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

Zytiga’s safety and effectiveness were established in a clinical study of 1,195 patients with late-stage castration-resistant prostate cancer who had received prior treatment with docetaxel chemotherapy. Patients received either Zytiga once daily in combination with prednisone two times a day or a placebo (sugar pill) twice daily in combination with prednisone.

The study was designed to measure overall survival, the length of time from when the treatment started until a patient’s death. Patients who received the Zytiga and prednisone combination had a median overall survival of 14.8 months compared to 10.9 months for patients receiving the placebo and prednisone combination.

The most commonly reported side effects in patients receiving Zytiga included joint swelling or discomfort, low levels of potassium in the blood, fluid retention (usually of the legs and feet), muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, high blood pressure, heartbeat disorders, urinary frequency, increased nighttime urination, upset stomach or indigestion and upper respiratory tract infection.

Zytiga is marketed by Horsham, Pa.-based Centocor Ortho Biotech, Inc.

Posted in Prostate HealthComments Off

MRI Highly Effective in Identifying Prostate Cancer Recurrence Even at Low PSA Levels

According to a study conducted by researchers at MD Anderson Cancer Center in Houston, a pelvic MRI scan with IV contrast and rectal balloon is highly effective in identifying local recurrence even at low PSA values in prostate cancer patients with a rising or persistently elevated PSA after prostatectomy.

For prostate cancer patients with rising PSA, a scan is typically performed after a prostatectomy and before salvage radiation therapy treatment.  This is to determine the potential recurrence and the location of the recurrence.  Researchers were not surprised that high rates of cancer recurrence were picked up by the MRI than the traditional CT scan as an MRI is able to differentiate between soft tissues better.  The surprise was the low PSA levels at which the MRI could determine recurrent disease.

Lead author of the study and assistant professor of radiation oncology at MD Anderson Cancer Center in Houston said “Being able to identify such patients is beneficial, as it would be predictive of response to salvage radiation therapy.  It also may allow a radiation oncologist to treat the area of recurrent cancer to a higher radiation dose with or without hormone ablation therapy to increase the chance of cure.”

The study evaluated 389 post prostatectomy patients treated between January 2004 and October 2010, with 143 receiving a pelvic MRI to determine if cancer cells were still present in the area of the surgical bed.  Of those patients, 35 had suspicious MRI findings suggesting a local recurrence where 26 patients were then biopsied, with 23 showing cancer.

The study showed that about one-third of patients with a biopsy proven recurrence after suspicious MRI finding had a PSA of less than 1, with several having a PSA as low as 0.3.

Posted in Prostate HealthComments Off

Research Study for Treatment of Lower Urinary Tract Symptoms (LUTS) Due To Benign Prostatic Hyperplasia (BPH)

Are you a man age 50 or older?

Do you have to urinate frequently during the day and at night?

Do you have trouble urinating?

Are these and other urinary problems interfering with your life and your relationships?

If you answered “yes” to the above questions, you may be a candidate for the L.I.F.T. Study.

The L.I.F.T. Study is an FDA approved research study to evaluate the UroLift system to support a premarketing application to FDA.  Its purpose is to determine the safety and effectiveness of the UroLift system for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).  The study is being conducted at urology practices throughout the U.S., in Canada and in Australia.

BPH is a non cancerous condition that causes the prostate to enlarge as men age.  When the enlarged prostate presses on the urethra, it can cause bothersome urinary symptoms. The UroLift System is a minimally invasive approach to treating BPH that lifts/holds the enlarged prostate tissue out of the way so it no longer blocks the urethra.  There is no cutting, heating or removal of prostate tissue. The goal of UroLift system treatment is to relieve symptoms so you can get back to your life and resume your daily activities.

The UroLift system is an investigational device as such is limited by Federal Law to investigational use only.

To find out more about L.I.F.T. Study and UroLift system treatment and study locations, go to www.neotract.com.

Posted in Bladder Health, Prostate HealthComments Off

Acupuncture Relieves Prostate Cancer Treatment Side Effects

The main treatment for men with prostate cancer focuses significantly on reducing the level of testosterone in the body by either surgery or hormone therapy. Testosterone is needed by the cancer to grow and spread.  Eliminating testosterone has been proven to keep the cancer in check.  However, this type of therapy also causes side effects such as hot flashes, similar to those of women experiencing menopause.  To relieve the hot flashes antidepressants are taken but these drugs have side effects of their own such as nausea, dry mouth, sleeplessness, altered appetite and sexual changes.

According to a study conducted by the Department of Radiation Oncology and the Acupuncture section of New York Methodist Hospital and Weill Cornell Medical College of Cornell University, both in New York, acupuncture provides long lasting relief to hot flashes, heart palpitations and anxiety due to side effects of the hormone given to counteract testosterone.

Researchers evaluated 14 men who were experiencing hot flashes due to hormone therapy for prostate cancer. Upon enrolling in the study, the men were given a hot flash score (HFS) to evaluate their discomfort from daily hot flashes.  The mean initial HFS was 28.3.

Participants then received acupuncture 2 times a week for 30 minutes for 4 weeks. The mean HFS after 2 weeks of acupuncture dropped to more than half (10.3), at 6 weeks 7.5 and after 8 months 7.

Hani Ashamalia, M.D., lead author of the study and a radiation oncologist at New York Methodists Hospital said “Our study shows that physicians and patients have an additional treatment for something that affects many men undergoing prostate cancer treatment and actually has long term benefits, as opposed to side effects”

Currently, the researchers are designing a randomized clinical trial to further evaluate acupuncture after prostate cancer treatment and are encouraging men suffering from this symptom to talk to their doctors about enrolling.

Posted in Prostate HealthComments Off

Progress in Prostate Cancer Detection with New Pro-PSA Test

For prostate cancer, the only current commercially available screening tests approved by FDA results in a high number of false positive results which leads to unnecessary biopsies, over detection and over treatment of indolent cancer. This is particularly true on the aggressive form of the cancer.

There is a new test that was recently approved for commercial use in Europe.  It is called Pro-PSA.  It measures a more specific PSA subform called -2 Pro-PSA.  It is even more accurate when the results are analyzed using a mathematical formula that provides an overall Prostate Health Index.  The formula divides the Pro-PSA number by the free-PSA. Then the quotient of the two is multiplied by the square root of the total PSA.

“The logic behind the formula is that the higher the Pro-PSA and total PSA and the lower the free-PSA, the more likely the patient has aggressive prostate cancer,” said lead investigator William Catalona, MD, Director of the Clinical Prostate Cancer program at Northwestern University in Chicago.

Dr. Catalona was the first to show, in 1991, that a simple blood test measuring PSA levels could be used to detect PCa.  In this current study, he and his colleagues followed 892 patients from 10 sites. The results, which was scheduled to be published in the May issue of the Journal of Urology, showed the new screening test was particularly useful for patients with a normal prostate exam whose PSA was in the 2-10 ng/mL range.

In their study, the researchers found that an increasing Prostate Health Index was associated with a 4.7-fold increased risk of prostate cancer and a 1.16-fold increased risk of Gleason 7 or greater disease on biopsy. Index results were not associated with age and prostate volume, Dr. Catalona said.

The FDA is currently reviewing the data from this current study.

Posted in Prostate HealthComments Off