The Urological Oncology Program has recently opened a new, investigator-initiated clinical trial for for men with metastatic castrate resistant prostate cancer and neuroendocrine prostate cancer. The principal investigator is Dr. Himisha Beltran.
For more information about the study, please call Renee Khan, RN at (212) 746-1851, e-mail Renee at firstname.lastname@example.org.
- Men age 18 and older
- Metastatic neuroendocrine prostate cancer
- Have had surgical or ongoing chemical castration (men with pure small cell neuroendocrine prostate cancer are not required to have received androgen deprivation therapy or castrate levels of testosterone)
- Detailed eligibility reviewed when you contact the study team
The purpose of the study is to evaluate how well men with neuroendocrine prostate cancer respond to treatment with the experimental drug MLN8237.
MLN8237 (also called alisertib) is a pill taken by mouth. It has been developed to interfere with cell division, which is required for cancer cell growth. Aurora A kinase is an enzyme that may have a role in the progression of prostate cancer to neuroendocrine prostate cancer, which tends to behave aggressively and not respond well to most other therapies used for advanced prostate cancer. MLN8237 works by blocking Aurora A kinase. This may interfere with dividing cells, thereby slowing the growth of cancer and killing cancer cells.
All study participants will receive MLN8237; there is no placebo used in this study. Participants will take MLN8237 in 21-day cycles:
- MLN8237 twice a day for 7 days in a row; after the 7 days of treatment, will not take it again for 2 weeks and then restart the cycle again
Study participants will continue with MLN8237 therapy as long as they are responding to treatment and not experiencing unacceptable side effects.
Weill Cornell’s Dr. Scott Tagawa and his research team are featured on the Department of Defense’s Congressionally Directed Medical Research Programs (CDMRP) website as one of the “2013 Prostate Cancer Research Highlights.” The article focuses on Dr. Tagawa’s research of an antibody called J591. J591 specifically recognizes prostate specific membrane antigen (PSMA), allowing prostate cancer cells to be targeted to be specifically targeted. Dr. Tagawa collaborated with Weill Cornell’s Dr. Neil Bander and his team to develop J591.
J591 was attached to a tiny radioactive particle called 177Lu. 177Lu-J591 seeks out prostate cancer cells and delivers a lethal dose of radiation to the areas of cancer, but not to normal areas. The researchers have been utilizing J591 in menwith metastatic prostate cancer for over a decade, with success in targeting metastatic tumors and decreases in PSA, tumor size, and pain symptoms.
The Defense Department’s Prostate Cancer Research Program Clinical Trial Award allowed the researchers to expand clinical testing of J591 through a multi-site, phase 2 clinical trial combining hormonal therapy with targeted J591 radiation. The researchers plan to initiate a Phase 3 trial of the radiolabeled J591.
Click here to read the CDMRP article.
The U.S. Preventive Services Task Force (USPSTF), a government panel, has issued a recommendation that men should not get routinely screened for prostate cancer using the PSA test. The panel found there is little evidence that testing for PSA, or prostate-specific antigen, saves men’s lives, and that it causes too much unnecessary harm from the treatment of tumors that would never have killed them. The panel concluded that the benefit of screening was outweighed by the potential risks, which include pain, fever, bleeding, infection and problems urinating, resulting from biopsies as well as incontinence and impotence associated with the treatment of tumors that would not have otherwise caused harm. Click here to read more about this on the Prostate Cancer Foundation website, including a dissenting opinion and comments from the Prostate Cancer Foundation.
The American Urological Association, one of the most significant professional associations for urologists, oncologists, and radiation oncologists focusing on prostate cancer has provided helpful information, primarily aimed at primary care physicians.
The USPSTF recommendations in no way affects men who have already been diagnosed with prostate cancer and have received or are currently receiving treatment. PSA remains one of the important tools to follow the results of treatment. We suggest that you discuss your PSA results with your physician.