AFFIRM Study

As part of Us TOO’s continued commitment to bring news of new interventions and treatments for the benefit of prostate cancer patients, I am pleased to share this news with you about the opportunity to participate in a new clinical trial for men with advanced, hormone-resistant prostate cancer.

AFFIRM (A Study Evaluating the EFFicacy and Safety of Investigational DRug MDV3100 in Men with Advanced Prostate Cancer), a new late-stage clinical trial now enrolling patients, will evaluate the efficacy and safety of the investigational drug MDV3100 as a treatment for advanced prostate cancer – specifically a type known as hormone-resistant prostate cancer. The study will evaluate the impact of MDV3100 on survival and other factors, including quality of life.

About MDV3100
The first triple-acting, oral anti-androgen, MDV3100 has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than the most commonly used anti-androgen, bicalutamide. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone from binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells and inhibits binding to DNA. Preclinical data published in Science demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.

About the AFFIRM Study
AFFIRM will enroll approximately 1,200 patients at sites in the United States and Canada, as well as in Europe, South America, Australia and South Africa. The study will test the efficacy and safety of MDV3100 in men with hormone-resistant prostate cancer that has progressed after chemotherapy.

Patients who were previously treated with the chemotherapy drug docetaxel may be eligible for the study. Two-thirds of patients will randomly be assigned to receive MDV3100 while 1/3 will receive placebo (sugar pill), which does not contain active medicine.

For more information on eligibility and enrollment, patients can call the AFFIRM study hotline toll-free at 1-888-782-3256 or visit www.affirmtrial.com

See flyer for additional
information:
http://www.ustooevents.org/site/DocServer/MEDPC4746_Flyer_Mv03.pdf?docID=17 61

I hope you find this type of information useful.
Please feel free to forward this message along to other men you know who are dealing with late-stage prostate cancer, or to physicians who might be interested in sharing the information with their other patients.

Sincerely,

Tom Kirk
President & CEO
Us TOO International

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