Tag Archive | "testosterone"

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 TreatmentComments 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 Inflammation, Prostate TreatmentComments Off

Research Underway for FDA Approved Investigational Medication for Prostate Cancer

Men naturally produce the male hormone testosterone which stimulates the prostate cancer cells. Constantly suppressing the testosterone can treat prostate cancer however this diminishes quality of life by causing loss of sexual interest, impotence, hot flashes, decreased mental ability, fatigue and even depression. In an effort to turn this around, patients are now being enrolled at Florida Urology Physicians to evaluate the role of a new method of suppressing cancer growth.

The study being conducted by Dr. Barry Blitz evaluates the role of an FDA investigational medicine that has been successfully treating prostate cancer to allow men to live years with fewer side effects than current therapies.

To qualify as a study participant, men must have been treated for prostate cancer and have a rising Prostate Specific Antigen (PSA). Study participants can receive study related exams, lab tests, and study medications at no charge. They are also compensated for their involvement.

Posted in Prostate Health, Prostate TreatmentComments Off


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