Trying to Prevent Prostate Cancer Cells from Spreading with Soy Protein
Raymond Bergan, MD, and William Catalona, MD (Researchers at Northwestern University)
Genistein is a component of soy protein. Our research has previously shown that genistein may prevent prostate cancer cells from moving throughout the body and metastasizing.
One of the standard treatments for localized prostate cancer is to surgically remove the prostate gland (called radical prostatectomy). However, even though the prostate gland has been removed, there is still a possibility that the cancer can return and move throughout the body. Once the cancer has moved throughout the body, or metastasized, it cannot be cured and is life threatening.
Therefore, we are conducting a study testing whether genistein could prevent prostate cancer from spreading and forming metastases in the bones and other organs. Since the formation of metastasis is the cause of death from prostate cancer, it would also mean that genistein may have the potential to stop or decrease death from prostate cancer.
In this study, we will first determine whether you have prostate cancer cells which have escaped from your prostate gland and have moved into your blood. To do this, we will remove a sample of your blood and test it for cells. If you are found to have prostate cancer cells in your blood, you will then be treated with either genistein or with an identical pill that does not contain genistein (placebo pill). Two out of every three patients will receive genistein and one will receive placebo.
You will take one pill each day for total of 3 months. You must be on treatment (i.e., take the pills) for at least two weeks prior to having your prostate removed. This will allow us to recheck your blood to see if genistein decreases the prostate cancer cells in your blood. However, you must have your prostate removed no longer than 3 months after you start treatment. During the time you are on treatment, and for one year after your prostate has been removed, we will periodically draw your blood to determine if you have any prostate cancer cells in your blood. In addition, we will measure the level of PSA (prostate-specific antigen) in your blood.
At the time you have your prostate removed by surgery, we will also collect some of the tissue from the prostate gland that has been removed. We will do this in order to measure the effects of genistein on the prostate cancer cells in your prostate. We will only use prostate tissue that is left over after the doctors have finished their examination of it.
The official title of the project is: Modulation of Prostate Cancer Cell Motility by the Chemopreventive Agent Genistein. It will be available at Northwestern Memorial Hospital, the University of Chicago Hospital, and NorthShore University Hospital.
For further information, please contact Sanjina Shrestha RN at 312.695.1995.
Effect of Dutasteride on Androgen-Response Gene Expression During the Tumor Regrowth Phase of Intermittent Androgen Ablation Therapy in Patients with Advanced Prostate Cancer (SPORE Trial)
(Zhou Wang, PhD and Daniel Shevrin, MD)
Intermittent androgen ablation therapy is frequently used as initial treatment for patients with advanced prostate cancer. We have demonstrated in the laboratory that certain androgen-response genes are overexpressed during the off-cycle (regrowth phase) of intermittent androgen treatment. We also have shown that testosterone is more potent in inducing these tumor suppressor genes than dihydrotestoesterone. Further, a 5a-reductase inhibitor given during the regrowth phase prolonged this time period and prolonged survival in test animals. We have designed a clinical trial to test the effect of dutasteride on the expression of a specific tumor suppressor androgen-response gene - U19. The purpose of this study is to find out if adding the drug dutasteride (Avodart) to androgen ablation therapy can improve treatment for prostate cancer. Another purpose of this study is to determine if the use of dutasteride slows the rise of blood PSA (Prostate Specific Antigen) during the "rest" cycles. It is known that PSA levels reflect tumor growth.
If you are interested in this study, have any questions, or want more information, please contact Dr. Daniel Shevrin at 847.570.2515 / dshevrin@northshore.org or our Study Coordinator Kat Schwartz, MS at 847.570.4193 kschwartz@northshore.org or Dr. Gary MacVicar at 312.695.0990 or
g-macvicar@northwestern.edu.
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy
The purpose of this study is to find out whether treatment with orteronel plus prednisone affects the time it takes for cancer to get worse compared to what might be expected. Additionally, it is to see if orteronel lengthens how long patients live compared to subjects in the study who receive placebo.
If you are interested in this study, have any questions, or want more information, please contact Dr. Gary MacVicar at 312.695.0990 g-macvicar@northwestern.edu
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects with Asymptomatic or Mildly Symptomatic Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
The purpose of this study is to find out whether treatment with orteronel plus prednisone affects the time it takes for cancer to get worse compared to what might be expected. Additionally, it is to see if orteronel lengthens how long patients live compared to subjects in the study who receive placebo.
The purpose of this study is to investigate an experimental drug, EMD 525797, in the treatment of prostate cancer.
If you are interested in this study, have any questions, or want more information, please contact Dr. Gary MacVicar at 312.695.0990 g-macvicar@northwestern.edu.
PREVAIL: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy (Department of Defense trial)
The purpose of this study is to determine if MDV3100 will help patients live longer, to determine if MDV3100 will delay the progression of cancer by increasing the amount of time before the cancer progresses, and to determine the safety of the study drug.
If you are interested in this study, have any questions, or want more information, please contact Dr. Shevrin at 847-570-2515 dshevrin@northshore.org or our Study Coordinator Kat Schwartz, MS at 847.570.4193 / kschwartz@northshore.org or Dr. Gary MacVicar at 312.695.0990 /g-macvicar@northwestern.edu.
Randomized Phase II Trial of Docetaxel with or without PSATRICOM Vaccine in Patients with Castrate-Resistant Metastatic Prostate Cancer (Eastern Cooperative Oncology Group Trial)
The purpose of this study is to find out if treating people with an experimental vaccine (called PSA-TRICOM) before chemotherapy is more beneficial than using standard chemotherapy by itself.
If you are interested in this study, have any questions, or want more information, please contact Dr. Gary MacVicar at 312.695.0990 / g-macvicar@northwestern.edu.
CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (Eastern Cooperative Oncology Group Trial)
This study is intended for men who have metastatic prostate cancer, meaning that the cancer has spread to other parts of the body besides the prostate. The study's objective is to determine if the addition of chemotherapy, consisting of docetaxel and prednisone, to hormonal therapy is better than hormonal therapy alone as initial treatment.
If you are interested in this study, have any questions, or want more information, please contact Dr. Gary MacVicar at 312.695.0990 / g-macvicar@northwestern.edu.
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