A new medication proved effective in slowing the spread of metastatic prostate cancer, while helping to maintain the quality of life, in patients with advanced disease. The phase 3 study was unblinded midway, allowing patients receiving the placebo to instead take the drug because of the favorable results.
The study is the first randomized clinical trial to document expanded benefits among a particular group of prostate cancer patients in whom the disease had spread. The medication, abiraterone acetate -- marketed as Zytiga – also delayed the development of pain and deterioration of the patients' overall condition.
The researchers say the medication could provide new treatment options.
"This drug extended lives and gave patients more time when they weren't experiencing significant pain from the disease,'' said the principal investigator of the international trial, Charles J. Ryan, MD, an associate professor of clinical medicine at the UCSF Helen Diller Family Comprehensive Cancer Center.
"This is an interim analysis, the final analysis should be available in 2014," he said. "But it appears that this medication may lay a foundation for the use of this drug at an earlier stage of prostate cancer, and its benefits may be able to be delivered to a much wider population of patients as a result.''
Ryan will present the data on June 2 at the 48th annual meeting of the American Society of Clinical Oncology in Chicago.
Prostate cancer is the second most common form of cancer in men, with some 30,000 people annually dying from the disease. Approximately one-third of patients require no treatment, because their disease does not metastasize, or spread, while another third are treated and cured. But for the remaining patients, the cancer will recur following treatment or spread to the bones, lymph nodes or other parts of the body. Prostate cancer can turn lethal when it spreads and when it resists standard hormonal therapy.
"These results are the culmination of years of research, and will truly transform the way we take care of patients with advanced prostate cancer,'' said Eric J. Small, MD, a UCSF professor and chief of hematology and oncology at the UCSF Helen Diller Family Comprehensive Cancer Center. He and Ryan have collaborated on the research of this class of medication for about 9 years.
"This is a wonderful milestone in our progress in treating prostate cancer, and provides advanced prostate cancer patients everywhere with an important new weapon to fight their cancer,'' he said.
Last year, the U.S. Food and Drug Administration approved abiraterone acetate for men whose disease had spread and who also were resistant to standard hormonal therapy, known as castration-resistant prostate cancer (CRPC) and had received chemotherapy with docetaxel. The approval was based on a clinical trial that showed the effectiveness of the medication in post-chemotherapy patients with more advanced disease.
In the new trial, the patients' cancer had metastasized and had become resistant to initial hormone therapy, but they were not showing considerable symptoms from the disease and had not yet received any chemotherapy.
The study involved 1,088 men at 151 cancer facilities in North America, Europe and Australia. On average, the patients had been diagnosed with prostate cancer five years earlier.
The patients were administered Zytiga in combination with low-dose prednisone. The trial was unblinded in March after it was determined that the drug delayed the need for chemotherapy and for pain medications, improved survival and quality of life. Zytiga also slowed the spread of cancer from an average of 8 months in the placebo group compared to approximately double the time in the treatment group. The medication demonstrated such clear advantages to patients that an independent monitoring committee recommended that patients receiving the placebo be allowed to receive the active drug.
"This trial with a well-tolerated oral agent slowed the progression of the disease while helping to delay suffering and maintaining quality of life in patients with advanced prostate cancer,'' said Ryan who has been researching the drug since 2004 and helped design the phase 3 study. "These are the goals that we are moving toward in cancer treatment. The treatment of advanced prostate cancer is undergoing a rapid transformation, and this drug is a key component of that transformation.''
The medication, by Janssen Research & Development, LLC targets prostate cancer by blocking the production of hormones produced by the cancer that can stimulate its growth. The medication was first created in a British lab in the 1990s. The manufacturer warns that it should be used with caution in patients who have a history of cardiovascular disease, high blood pressure, low blood potassium, and fluid retention.
UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.Follow UCSF
Elizabeth Fernandez | EurekAlert!
Researchers image atomic structure of important immune regulator
11.12.2018 | Brigham and Women's Hospital
Potential seen for tailoring treatment for acute myeloid leukemia
10.12.2018 | University of Washington Health Sciences/UW Medicine
Over the last decade, there has been much excitement about the discovery, recognised by the Nobel Prize in Physics only two years ago, that there are two types...
What if a sensor sensing a thing could be part of the thing itself? Rice University engineers believe they have a two-dimensional solution to do just that.
Rice engineers led by materials scientists Pulickel Ajayan and Jun Lou have developed a method to make atom-flat sensors that seamlessly integrate with devices...
Scientists at the University of Stuttgart and the Karlsruhe Institute of Technology (KIT) succeed in important further development on the way to quantum Computers.
Quantum computers one day should be able to solve certain computing problems much faster than a classical computer. One of the most promising approaches is...
New Project SNAPSTER: Novel luminescent materials by encapsulating phosphorescent metal clusters with organic liquid crystals
Nowadays energy conversion in lighting and optoelectronic devices requires the use of rare earth oxides.
Scientists have discovered the first synthetic material that becomes thicker - at the molecular level - as it is stretched.
Researchers led by Dr Devesh Mistry from the University of Leeds discovered a new non-porous material that has unique and inherent "auxetic" stretching...
10.12.2018 | Event News
06.12.2018 | Event News
03.12.2018 | Event News
11.12.2018 | Physics and Astronomy
11.12.2018 | Materials Sciences
11.12.2018 | Information Technology