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Prostate cancer trial recruiting men who want to get off the bench and become true champions

prostate clinical trial May2015 postPat Riley, president and head coach of the Miami Heat, once said “There’s always the motivation of wanting to win. Everybody has that. But a champion needs, in his attitude, a motivation above and beyond winning.” Widely regarded as one of the greatest National Basketball League coaches of all time, Riley knows a thing or two about what it takes to be a champ.

Participating in clinical trials is a lot like being on a sports team. For most of the time, there’s no way to know if the trial is winning, losing or even making a score. Participants’ commitment and endurance may be tested through extra travel and doctor visits or tests. The trial could be short, or it may take a long time to complete. It might even go into overtime. And there are no guarantees, either about the trial’s outcome or about benefits to participants.

With all that uncertainty, the true champion in a clinical trial is the participant who, like Pat Riley said, is motivated above and beyond winning.

“Cancer patients need to know that every drug that is available for them was, at some point in the past, part of a research trial. Some don’t choose to participate, others do. But when we discuss the options of joining a clinical trial, I tell them that they should do what they feel is good for them,” says Maha Hussain, M.D., F.A.C.P., a urologic medical oncologist at the U-M Comprehensive Cancer Center. She is leading a clinical trial at the U-M called PROSPER for men who have prostate cancer but no evidence that it has spread to other parts of the body.

The PROSPER Clinical Trial is a global multi-site Phase 3 clinical research trial that will include about 1500 participants. The trial tests the effects of an oral investigational drug called enzalutamide in men with non-metastatic prostate cancer that continues to progress despite hormonal therapy as reflected by rising PSA. The purpose of the PROSPER Clinical Trial is to compare how enzalutamide works when combined with standard treatment versus the standard treatment only.

Men with prostate cancer may qualify for the trial if they have:

  • Rising PSA (2 ng/mL or higher), despite treatment with hormonal therapy
  • Cancer that has not spread beyond the prostate
  • No pain caused by the cancer
  • No prior chemotherapy

In the PROSPER trial, patients will have a two out of three chance of being randomized to receive enzalutamide or a one in three chance of receiving a placebo. All patients will continue to receive standard treatment in addition to their respective drug/placebo assignment.

Dr. Hussain points out that it is only during a brief window of time that men can be considered for this trial, namely, while their PSA scores are rising, but before there is evidence of metastasis.

“The trial wants to find out if taking enzalutamide (a drug that has demonstrated effect on prolonging survival for patients with visible hormone resistant cancer) along with standard treatment will delay cancer’s spread to other places in the body. The longer we can push back that visible, or metastasized cancer, the more time patients will have to live without the imminent threat of visible cancer. Delaying metastasis is hoped to also improve longevity and if so, then it buys time during which new drugs and treatments might become available to extend their lives even more,” she says.

Continue learning about prostate cancer and clinical trials:

Still have questions? Call the nurses at the University of Michigan Cancer AnswerLine™. They can help patients or their loved ones who are interested in this, or other clinical trials. Feel free to call at 1-800-865-1125 or send an e-mail.


Maha Hussain, M.D.Maha Hussain, M.D., FACP, FASCO, is the Cis Maisel Professor of Oncology and associate director for clinical research at the U-M Comprehensive Cancer Center. She is also the co-leader of the prostate cancer/genitourinary oncology program. Hussain is an internationally renowned clinical researcher and an expert in genitourinary malignancies, particularly prostate and bladder cancers. Her research efforts are focused on the development of novel therapeutics integrating scientific advances into clinical trials for prostate and bladder cancer patients.

 

Cancer-center-informal-vertical-sig-150x150The University of Michigan Comprehensive Cancer Center’s 1,000 doctors, nurses, care givers and researchers are united by one thought: to deliver the highest quality, compassionate care while working to conquer cancer through innovation and collaboration. The center is among the top-ranked national cancer programs, and #1 in Michigan for cancer patient care. Seventeen multidisciplinary clinics offer one-stop access to teams of specialists for personalized treatment plans, part of the ideal patient care experience. Patients also benefit through access to promising new cancer therapies.