Clinical trials show promise for prostate cancer drug

January 30, 2014

A 30 percent reduction in mortality risk is one of the impressive results achieved in a global clinical drug trial for the treatment of prostate cancer. The full trial data are due to be presented today at one of the world´s most important oncology conferences, the ASCO GU. The development of the unusually effective cancer drug was also based on three clinical trials carried out by the Clinical Program on Urological Tumours at Vienna General Hospital. Participants in the trial at the hospital already had access to treatment using the drug for four years. Recently, the trial was terminated prematurely - the outstanding results prompted the supervisory board to make the drug available as quickly as possible to the placebo control group.

The symposia of the American Society of Clinical Oncology (ASCO) are considered internationally as the most important forums for the presentation of new research findings on cancer treatment. Urgently awaited data on a new androgen receptor antagonist are being presented today at the ASCO Genitourinary (GU) Symposium in San Francisco. The was developed for the treatment of so-called castration-resistant (CRPC) and inhibits the tumor growth triggered by the male sex hormone. According to the trial data, the drug can actually reduce the of by 30 percent. Moreover, the risk of progressive tumor growth or the death of the affected person was reduced by 81 percent reduction as compared with a placebo group.

"The data presented today," explains Professor Michael Krainer, director of the Clinical Program on Urological Tumours at Vienna General Hospital, "relate to patients who have not yet received any chemotherapy. The potential new application for this drug offers an effective alternative treatment for this group of patients." The drug was actually licensed in 2013 for patients who had already undergone chemotherapy. Based on the convincing outcomes observed in these patients, trials were quickly carried out on its use in so-called chemotherapy-naïve patients. The results of an intermediate assessment of this clinical phase 3 trial were so conclusive that the Independent Data Monitoring Committee (IDMC) recommended the termination of the trial. In this way, not only could the control group be given access to the new drug as quickly as possible, the overall licensing process could also be accelerated.

The clinical trial was carried out throughout the world at centers in the USA, Canada, Australia, Russia and European countries. The Urological Tumors research group at Vienna General Hospital has been involved in the development and licensing of the drug since 2009. As a result, it has been possible to treat numerous patients with the drug in the context of three clinical trials. The Viennese research group is one of the most renowned clinical monitors in the area of prostate carcinoma in Europe: several hundred patients have been enrolled in 17 clinical trials at the hospital since 2002. The spectrum of the clinical trials covers all modern therapeutic alternatives from chemotherapy through to hormone and immunotherapy. The group is, in fact, the largest research center throughout Europe for a special immune therapy drug.

"Participation in clinical trials gives patients early access to the very latest treatments and enables highly intensive monitoring," says Prof Krainer, explaining the benefits of clinical trials which he has observed through many years of experience. "In fact, we know that even patients in control groups benefit from participation in . The overall experience of a highly motivated and internationally committed clinical monitoring team has a comprehensive impact here." However, even patients who are not able to fulfil the strict acceptance criteria for such studies can be treated with the very latest drugs at centers like the Urological Tumors research group. Prof Krainer explains further: "So-called named patient programs enable us to treat patients, for whom there are no treatment alternatives, with drugs that are still undergoing the licensing process. Clinical studies thus offer real benefits for patients in several respects."

Explore further: Study shows benefits for men with metastatic prostate cancer who receive chemotherapy when starting hormone therapy

More information: Ferlay, J., et al., "Estimates of the cancer incidence and mortality in Europe in 2006." Ann Onc 2007; 18(3):581-92

Related Stories

Study shows benefits for men with metastatic prostate cancer who receive chemotherapy when starting hormone therapy

December 6, 2013
Men with hormone-sensitive metastatic prostate cancer who received the chemotherapy drug docetaxel given at the start of standard hormone therapy lived longer than patients who received hormone therapy alone, according to ...

Why combination drug treatment ineffective in cancer clinical trials

December 5, 2013
Medical researchers at the University of Alberta have discovered that combination drug therapy didn't work well in clinical trials for cancer patients because one drug was making the other drug ineffective.

New drug extends life in women with advanced ovarian cancer

November 5, 2013
Women with ovarian cancer that has returned after previous treatment had their life extended by almost three months after treatment with a drug called Cediranib, according to trial results presented today at the National ...

Study shows new paradigm in breast cancer research

December 13, 2013
The first investigator results from an unprecedented nationwide effort to test promising new breast cancer drugs before the tumor is removed were presented during the 2013 San Antonio Breast Cancer Symposium.

PIK3CA gene mutations make HER2- and hormone receptor-positive breast cancers treatment-resistant

December 12, 2013
Women with breast cancer characterized by high levels of the protein HER2 and hormone receptors gained much less benefit from presurgery treatment with chemotherapy and HER2-targeted therapies if their cancer had one or more ...

Income affects oncology clinical trial participation

January 16, 2013
(HealthDay)—Oncology patients with lower income, even older patients with access to Medicare, are significantly less likely to participate in clinical trials, according to research published online Jan. 7 in the Journal ...

Recommended for you

Shooting the achilles heel of nervous system cancers

July 20, 2017
Virtually all cancer treatments used today also damage normal cells, causing the toxic side effects associated with cancer treatment. A cooperative research team led by researchers at Dartmouth's Norris Cotton Cancer Center ...

Molecular changes with age in normal breast tissue are linked to cancer-related changes

July 20, 2017
Several known factors are associated with a higher risk of breast cancer including increasing age, being overweight after menopause, alcohol intake, and family history. However, the underlying biologic mechanisms through ...

Immune-cell numbers predict response to combination immunotherapy in melanoma

July 20, 2017
Whether a melanoma patient will better respond to a single immunotherapy drug or two in combination depends on the abundance of certain white blood cells within their tumors, according to a new study conducted by UC San Francisco ...

Discovery could lead to better results for patients undergoing radiation

July 19, 2017
More than half of cancer patients undergo radiotherapy, in which high doses of radiation are aimed at diseased tissue to kill cancer cells. But due to a phenomenon known as radiation-induced bystander effect (RIBE), in which ...

Definitive genomic study reveals alterations driving most medulloblastoma brain tumors

July 19, 2017
The most comprehensive analysis yet of medulloblastoma has identified genomic changes responsible for more than 75 percent of the brain tumors, including two new suspected cancer genes that were found exclusively in the least ...

Novel CRISPR-Cas9 screening enables discovery of new targets to aid cancer immunotherapy

July 19, 2017
A novel screening method developed by a team at Dana-Farber/Boston Children's Cancer and Blood Disorders Center—using CRISPR-Cas9 genome editing technology to test the function of thousands of tumor genes in mice—has ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.