A newly awarded grant aims to reward collaboration among the nation's top cancer centers by hastening the development of prostate-cancer clinical studies. Such efforts could pave the way for rapid advances and new treatments for prostate cancer, which affects one man in six during his lifetime.
Dr. Celestia (Tia) Higano, a prostate-cancer specialist at the Seattle Cancer Care Alliance, recently received a two-year grant worth $912,836 from the Department of Defense to enable participation in a national clinical research group. The DOD began the group, the Prostate Cancer Clinical Trials Consortium, in 2005 with the objective of streamlining the implementation and conduct of multi-institutional phase I and phase II trials.
The grant, which will be administered through the University of Washington, is a sign of respect, Higano said. "Being chosen to be part of this consortium validates us as being one of the major prostate-cancer clinical trial groups in the country," she said. "I think it's great recognition of lots of years of hard work and a fantastic team of collaborators here on our research team — the physicians and the research personnel. We're tried and true."
"I think being part of this group will improve our profile both on a local level and a national level. It will also enhance our translational research with other similar institutions."
The group, with its coordinating center at Memorial Sloan-Kettering Cancer Center, includes researchers from Dana-Farber/Harvard Cancer Center, Johns Hopkins Prostate Cancer Program, Oregon Health and Science University, University of California San Francisco, University of Michigan, M.D. Anderson Cancer Center, University of Wisconsin and Duke Comprehensive Cancer Center.
Consortium studies focus on the evaluation of novel agents for the management of prostate cancer at all stages of the disease. Consolidating study coordination enables expedited concept and protocol review, standardized protocol and contract language, and centralized data management to help test needed therapies more rapidly. Sponsors interested in conducting a trial through the consortium can contact an investigator at any member institution.
The grant funds the infrastructure of each institution's participation in the consortium, but does not fund the actual research. "By combining together, we hope to complete innovative prostate-cancer trials sooner than we would as a single institution, going it alone," said Higano, a UW associate professor of medicine.
Drug trial for muscle wasting
Higano's group is already participating in two trials under the umbrella of the DOD grant. One is a joint trial with the University of Michigan of a chemotherapy drug called Aplidin. Future phases of that trial may be expanded through the consortium members. The other trial uses anti-CTLA4 antibodies as a type of immune therapy for prostate and renal-cell cancer. The Johns Hopkins and Memorial Sloan-Kettering sites have studies under way with the same agent.
Higano is currently conducting a trial of a new agent called AMG745 that may help build muscle. While it isn't a traditional anti-cancer therapy, muscle wasting is a significant problem for prostate-cancer patients who have been treated with hormonal therapy. "We're going to give this new drug to men who have been on androgen deprivation for their prostate cancer and see if it builds muscle after one month," she said. If the results are promising, Higano believes the drug study may be expanded for use in patients with AIDS and other diseases that cause muscle wasting. Some research has shown evidence that prevention of muscular atrophy may decrease mortality.
Phase II trial
Higano and colleagues are also currently conducting a phase I trial of an insulin-like growth factor in patients with metastatic cancer. Insulin-like growth factor is thought to be responsible for furthering cancer's growth once it is developed. "By interrupting this growth factor, we can treat cancer. We'd like to bring the phase II development of this agent to the consortium," Higano said. "We want to be able to use the insulin-like growth factor in combination with chemotherapy and androgen-deprivation therapy in different stages of prostate cancer."
Higano sees great value in tackling difficult clinical problems collaboratively. "Everybody has been so focused on making their own local, national and international reputations, but this is kind of a way of prompting all of us to work together to do something positive for this disease," she said of prostate cancer, which is second only to lung cancer as a leading cause of cancer deaths in men. "It's time for us to change our way of thinking about how we do things. This legitimizes that concept and gives us incentive to make it happen."