March 09 Newsletter Articles

FDA Approves New Prostate Cancer Drug

Federal regulators said they have approved the first new drug to treat prostate cancer in four years.

The injectable treatment from privately held Ferring Pharmaceuticals fights the cancer by lowering levels of testosterone, which promotes the growth of tumors in the prostate.

Food and Drug Administration officials said older drugs in the same class can actually increase testosterone production before they begin lowering them. In studies on prostate cancer patients, Ferring showed that its drug, degarelix, does not raise testosterone levels.

According to the FDA, patients treated with degarelix had testosterone levels comparable to those seen after the testes are removed.

"Prostate cancer is the second leading cause of cancer death among men in the United States and there is an ongoing need for additional treatment options," Richard Pazdur, the FDA's cancer drug chief, said in a statement. Prostate drugs in the same class as degarelix include AstraZeneca's Zoladex and Abbott Laboratories' Lupron Depot.

WASHINGTON (AP)

PSA DOUBLING TIME AND TIME TO BIOCHEMICAL FAILURE MAY PREDICT PROSTATE CANCERSPECIFIC MORTALITY

Time to biochemical failure and PSA doubling time may be useful surrogate markers for prostate cancer-specific mortality among patients who fail curative treatment according to an article published in the journal Lancer Oncology (Vol. 9, pp. 1058-2068, 2008).

Researchers from the School of Medicine and Public Health in Newcastle, Australia and the Wellington Cancer Centre in New Zealand conducted a surrogacy study to determine the efficacy of time to biochemical failure and PSA doubling time as surrogate markers using data from the TransTasman Radiation Oncology Group 96.01 trial. The trial included 802 men with locally advanced prostate cancer. From 1996 to 2000, participants were randomly assigned to prostate irradiation or to three or six months of maximum short-term androgen deprivation therapy (ADT) before and during radiation, according to the researchers.

Compared with radiation alone, short term ADT for six months decreased prostate cancer specific mortality (HR=0.56; P=0.Ol); however, ADT for three months did not (HR=0.95; P0.79, non-significant difference).

PSA doubling time successfully predicted the time from randomization to death from prostate cancer and satisfied four Prentice criteria at cut points of <12 months and <15 months. Proportion of treatment effect ratios was between 0.36 and 0.56. However, time to biochemical failure was superior at predicting the trial finding and satisfying Prentice criteria at cut points <1.5 years, <2 years and <2.5 years. The proportion of treatment effect ratios was between 0.45 and 0.64.

According to the researchers, PSA doubling time and time to biochemical failure may have the potential to reduce follow-up in clinical trials.

HeinOnco Today, 5 November 2008

RETHINKING PROSTATE CANCER IN OLDER MEN

Research suggests aggressive treatment is viable, even for patients in their late 70s

With increasing life expectancies, improved surgical tools, and better information on patient results, many older men diagnosed with early prostate cancer are taking a pass on the traditional advice to hold off on treatment for a period of time. So-called "watchful waiting" closely monitoring the cancer's progression - is still a viable option. But many experts now believe that aggressive treatment, even for older men, may be the better way to go.

A study published in the 4 February 2008 issue of the Journal of the American Medical Association helped shake up the conventional wisdom. The study, which involved some 44,000 men, found that the death risk for those who received prostate cancer treatment was nearly one third lower than for men who received no treatment. And that was true across all age categories, including the oldest men in the study, aged 75 to 80.

"We often think of prostate cancer as an indolent disease, and it is for many men, which is why observation is a very reasonable treatment option for patients with low and intermediate risk disease," said the study's lead author, Dr. Yu-Ning Wong, a medical oncologist at the Fox Chase Cancer Center in Philadelphia. "However, the life expectancy for a 70-year-old man is about 13 years, and patients who are otherwise healthy should recognize that if they live long enough, they may be at risk of developing complications from prostate cancer," she added.

Observation or "watchful waiting" does not mean watching someone die. Many oncologists today prefer the term "active surveillance," said Dr. Edouard J. Trabulsi, assistant professor in the department of urology at Jefferson Medical College and co-director of the Jefferson Prostate Diagnostic Center in Philadelphia. It more accurately describes the diligent approach to monitoring these patients, including the use of PSA blood tests, digital rectal exams and biopsies of the prostate to detect changes in the cancer.

Because prostate cancer is generally a slow-growing cancer, some men may never need treatment. And for many older men without symptoms, watchful waiting has been recommended, because it was believed they would die from other causes before their cancer advanced. But as men's life expectancy creeps higher and new robotic techniques improve the precision of surgery, the decision is becoming more complicated.

"Patients should understand the risks and benefits of all their treatment options - radiation, surgery (radical prostatectomy) and observation," Wong noted. "If they choose observation, they should be committed to careful follow-up with their physicians."

A new study due to be completed next year may help answer these questions. The NCI and the VA Department are co-sponsoring a study, called the Prostate Cancer Intervention Versus Observation Trial, to compare surgery and expectant management on patient survival and overall quality of life.

HealthDay News, 17 October 2008