Lombardi Comprehensive Cancer Center Clinical Trials Protocol

Cancer Type: Prostate

Hospitals offering this trial


 
Pro00000023
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

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Georgetown University Hospital Franklin Square Hospital Center Good Samaritan Hospital Harbor Hospital Union Memorial Hospital Washington Hospital Center
 

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.

Contact: Holly DiFebo
Email: hmd27@georgetown.edu
Phone: 202-687-2007



 
2009-599
Phase II Study to Evaluate the Efficacy of Intensity Modulated Radiation Therapy with Hypofractionated Radiosurgical Boosts in the Treatment of Clinically Localized Prostate Cancer

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Georgetown University Hospital Franklin Square Hospital Center Good Samaritan Hospital Harbor Hospital Union Memorial Hospital Washington Hospital Center
 

This is a phase II study designed to prospectively evealuate the efficacy and morbidity of IMRT with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients with clinically localized prostate cancer will be treated with three radiosurgical treatments (6.5 Gy per a fraction to the PTV) followed by IMRT (45 Gy in 25 fractions) Treatment will be completed over a 6-7 week period.

Contact: Heather Hanscom
Email: heather.n.hanscom@gunet.georgetown.edu
Phone: 202-444-3068
 
2011-176
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 

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Georgetown University Hospital Franklin Square Hospital Center Good Samaritan Hospital Harbor Hospital Union Memorial Hospital Washington Hospital Center
 

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.

Contact: Ann Gallagher
Email: ALG@georgetown.edu
Phone: 202-687-7606

Pro00000005
NCI 8986: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of ARQ 197 (Tivantinib) in Men with Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer.

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This study is for men with advanced prostate cancer that is no longer completely controlled with hormonal therapy as determined by a rising Prostate Specific Antigen (PSA). In order to participate in this trial you cannot be experiencing anything more than mild symptoms from your prostate cancer. The purpose of this study is to further test the safety and benefit of ARQ 197 in men with advanced prostate cancer that has become resistant to hormonal therapy yet is not causing symptoms. ARQ 197 is a new drug that blocks the function of a protein called C-MET. The C-MET protein has been found to be important in the growth of cancers including advanced prostate cancer that is no longer responding to hormonal therapy. ARQ 197 is an investigational anticancer agent that has not yet been approved by the Food and Drug Administration for use in advanced prostate cancer. Subjects taking part in this study will be randomized (like the flip of a coin) to receive either ARQ 197 3 tablets twice per day or a matching placebo (pill that looks like ARQ 197 but does not contain active medicine). Subjects who are assigned to placebo will be able to be switched to active medicine if their disease gets worse.

Lombardi/MedStar Georgetown Hospital

Contact: Divyesh Kukadiya
Email: dk365@georgetown.edu
Phone: 202-687-7354

2013-0367
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. 

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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.

Lombardi/MedStar Georgetown Hospital; Washington Hospital Center

Contacts: Holly DiFebo; Divyesh Kukadiya
Email: hmd27@georgetown.edu; dk365@georgetown.edu
Phone: 202-687-2007; 202-687-7354

2013-0952
P12-2: A Randomized, Open-Label, Phase 2 Study of Sipuleucel-T with Concurrent versus Sequential Administration of Enzalutamide in Men with Castrate-Resistant Prostate Cancer.

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This study is for men who have prostate cancer which is progressing in spite of a low testosterone level.
The main purpose of this study is to learn if there is any difference between giving enzalutamide at the same time as sipuleucel-T versus giving enzalutamide after treatment with sipuleucel-T.
Other purposes of this study are to see how the immune system responds to sipuleucel-T, to learn more about the safety of taking sipuleucel-T with enzalutamide and to collect information about other prostate cancer treatments.
Sipuleucel-T is an autologous cellular immunotherapy because it uses the body’s own immune cells to stimulate an immune response against prostate cancer. Autologous means the cells come from one's own body and are used to make the infusions.
Enzalutamide is a hormone therapy that blocks testosterone production in the body to slow or stop the growth of prostate cancer cells.
All subjects will receive both treatments. Subjects will be randomized (like the flip of a coin) to receive the two treatments at the same time or to receive enzalutamide after the sipuleucel treatments are finished.


2009-485
CALGB 90601: A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, And Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma

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Pro-662
A Study to Evaluate Cardiovascular Risk Factors and Receipt of Primary and Preventive Care in Prostate Cancer Patients who Receive Definitive Radiation Therapy and Androgen Deprivation Therapy.

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This pilot study will evaluate the proportion of prostate cancer patients receiving external beam radiation therapy (EBRT) and androgen deprivation therapy (ADT) who have controlled blood sugars (fasting glucose and hemoglobin A1c), blood pressure, and cholesterol profile (total cholesterol, LDL, HDL, triglycerides) at baseline (prior to treatment), and at 3 months and 12 months after completing radiation treatment. In addition, receipt of guideline-recommended cardiovascular, primary and preventive care as well as patient-reported quality of life and satisfaction with care among these patients will be evaluated at baseline and 12 months.


2014-0057
A031201: Phase III Trial of Enzalutamide (NSC # 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer.

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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.