A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients with High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy.
This study is for men with prostate cancer whose prostate specific antigen (PSA) level is elevated after surgery or radiation and hormonal therapy (castrate resistant prostate cancer), and x-ray scans do not show that the cancer is spreading. The purpose of this study is to test how well the study drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone works against prostate cancer. The study drug in this study includes an antibody called J591. It is a protein which can bind to a specific site on a prostate cancer cell. A very energetic radioactive metal called 177Lutetium (abbreviated: 177Lu) is attached to the J591 antibody. The fully assembled drug is called 177Lu-J591. The study will assess how well the energy given off by the radioactive drug kills cancer cells. This study may also involve the use of 111Indium. This is also an energetic radioactive particle, but does not generally give off enough energy to kill cancer cells, but allows doctors to take pictures. This radioactive particle is also attached to the J591 antibody (called 111In-J591) and will serve as a placebo (treatment with no active medicine). All subjects on this study will also take ketoconazole and hydrocortisone pills which are a standard treatment for castrate resistant prostate cancer.
CALGB 70807: The Mens Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance.
You are being asked to take part in this study because you have been diagnosed with prostate cancer and are receiving regular follow-up care with your primary physician. You are being asked to take part in a research study of men who are undergoing active surveillance for their prostate cancer. The purpose of this study is to find out more about how diet may prevent prostate cancer from getting worse.
SWOG S1216: A Phase III Randomized Trial Comparing Androgen Deprived Therapy + TAK-700 with Androgen Deprived Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer.
You are being asked to take part in this study because you have prostate cancer that has spread and you are either beginning hormone therapy for the first time or have been on hormone therapy for less than 30 days. The purpose of this study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone. The combination of TAK-700 and standard hormone therapy is considered experimental. TAK-700 is a pill that works by reducing the levels of testosterone and other male hormones that help your prostate cancer grow. TAK-700 acts on the adrenal glands and inside the prostate tumors and slows the amount of male hormones being produced. By lowering the amount of male hormones in your body, TAK-700 is expected to control the growth of your prostate cancer.
A031201: Phase III Trial of Enzalutamide (NSC # 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer.
The purpose of this study is to compare the effects, good and/or bad, of abiraterone, prednisone, and enzalutamide with enzalutamide alone on you and your prostate cancer to find out which is better. Doctors are uncertain about what is the best way to treat castration resistant prostate cancer (CRPC). In this study, you will get either the combination of abiraterone, prednisone, and enzalutamide or enzalutamide alone. Abiraterone and enzalutamide are both hormonal agents approved by the Food and Drug Administration for patients with castration-resistant metastatic disease. Each drug works in a different way to block hormones. Abiraterone and enzalutamide are both highly active drugs in men with CRPC. Abiraterone has recently received FDA approval for patients who have not received chemotherapy, such as you. In previous studies, enzalutamide appeared to be at least as active as abiraterone in patients with CRPC who have received prior chemotherapy, and it may be at least as active in patients who have not received chemotherapy. The combination of abiraterone, prednisone, and enzalutamide is considered experimental. In addition, giving enzalutamide in patients who have not received chemotherapy is considered to be experimental.
CALGB 90203: A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer
The purpose of this study is to compare the effects (good and bad) of the combination of chemotherapy and hormone therapy followed by radical prostatectomy (surgery to remove your prostate) with radical prostatectomy alone on you and your prostate cancer to see which is better. This research is being done because many men with your type of prostate cancer are at risk of having the cancer come back if they are treated only with surgery. We are trying to find out if giving chemotherapy with hormone therapy before surgery makes the chance of being cured of prostate cancer better. We are also going to study whether anything in your diet or lifestyle predicts how well you do overall with your cancer.
A randomized open-label phase IIa study evaluating the efficacy and safety of Radium-223 dichloride in combination with abiraterone acetate or enzalutamide in subjects with castration-resistant prostate cancer (CRPC) who have bone metastases
This study is for men with prostate cancer that is resistant to medical or surgical treatments that lower testosterone levels in the body, and whose prostate cancer has also spread to their bones.
The main goal of this study is to understand whether it is safe and effective to combine Radium-223 dichloride with abiraterone acetate plus prednisone or with enzalutamide. All of the medications used in the study have been previously approved by the FDA, but not in combination with each other. This study will evaluate the safety and potential benefit of using these drugs in combination.
3 types of treatment will be evaluated in this study. These are the 3 types of treatment:
- Radium-223 dichloride administered intravenously (into a vein) once every 4 weeks;
- Radium-223 dichloride administered intravenously every 4 weeks together with abiraterone acetate by mouth daily plus prednisone by mouth twice a day; or
- Radium-223 dichloride administered intravenously every 4 weeks together with enzalutamide by mouth daily.
Subjects will be assigned randomly on either of the above mentioned treatment arm.
Bayer 15396: A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC)
This study is for men with prostate cancer that is resistant to medical or surgical treatments that lower testosterone levels in the body, has spread to the bones with mild or no symptoms (the spread of cancer is called metastasis), and have not received chemotherapy for prostate cancer.
One of the standard treatments for your type of prostate cancer is abiraterone and prednisone or prednisolone. The main goal of this study is to understand if adding radium-223 dichloride to abiraterone acetate and prednisone or prednisolone helps men survive longer with a delay in occurrence of symptomatic skeletal events such as bone fractures related to prostate cancer metastasis with symptoms of pain, a new spinal cord compression, or use of surgery or radiation to relieve your bone symptoms. Radium-223 dichloride has been approved by the U.S. Food and Drug Administration (FDA), but is not approved yet to be combined with abiraterone and prednisone or prednisolone. This study will evaluate the safety and potential benefit of using these drugs in combination.
There will be two treatment groups in this study. All study subjects will receive treatment with abiraterone acetate (1000 mg once a day by mouth) and prednisone/prednisolone (5 mg twice a day by mouth). You will also receive one of these two treatments:
- Radium-223 dichloride administered intravenously (into a vein) once every 4 weeks
- Saline administered intravenously (into a vein) once every 4 weeks