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Understanding Prostate Cancer

Clinical Trials

Clinical drug trials play a crucial role in moving new treatments to patients who need them most, securing data so regulatory approvals can be obtained and new drugs can move into widespread clinical practice. Patients who participate in clinical trials provide an invaluable service both to treatment science and fellow patients.

There are currently more than several Phase III drug trials and more than 90 Phase I/II trials in process for prostate cancer in North America and Europe. Those that are approved will join the five new drugs that have been approved for men with advanced metastatic disease in the past two years and further improve outcomes for patients:

Jevtana (cabazitaxel)

Provenge (sipuleucel-T)

Xgeva (denusomab)

Xofigo (radium 223 dichloride)

Xtandi (enzalutimide)

Zytiga (abiraterone)

The resources on this page can direct you to clinical trials that are currently open for enrollment in your local area, as well as across the country. If you are considering a clinical trial, speak to your doctor about the potential benefits of participating in a trial so you can make an informed decision that is best for you.


Frequently Asked Questions (FAQs)

To view our FAQs about Clinical Trials, please visit here.


 

Prostate Cancer Clinical Trials Consortium

The Prostate Cancer Clinical Trials Consortium (PCCTC) is a 13-member clinical research group sponsored by the Prostate Cancer Foundation and the Department of Defense Prostate Cancer Research Program (PCRP), with its Coordinating Center headquartered at Memorial Sloan-Kettering Cancer Center.

Visit the PCCTC site for trial information: www.pcctc.org


Open Trials

 

 

ARMOR3-SV

New hormonal medicines have expanded the treatment options available for men with advanced prostate cancer. Unfortunately, not all men benefit from these medicines. For some men, hormonal medicines may only work for a while and then stop working. For others, they may not work at all.

Early research has shown that men who test positive for "AR-V7" are less likely to benefit from Zytiga, or Xtandi, which are the only two approved hormonal medicines for patients whose castrate-resistant prostate cancer (CRPC) has spread. AR-V7 can be found through a simple blood test.

Using blood tests to help choose medicines has improved results in several types of cancer.

ABOUT THE ARMOR3-SV CLINICAL TRIAL

The ARMOR3-SV clinical trial is for men with CRPC that is metastatic (has spread beyond the prostate to other parts of the body), who have not yet been treated with chemotherapy or certain oral hormonal medicines, and whose cancer is progressing.

The ARMOR3-SV clinical trial will test whether galeterone, an experimental medicine, is helpful for patients who have a substance in the blood called "AR-V7". The trial will compare galeterone against Xtandi in men who test positive for AR-V7.

Galeterone is the first in a new class of medicines for patients who have AR-V7. Research has shown that metastatic CRPC patients who have AR-V7 may be less likely to benefit from existing hormonal medicines like Xtandi®.

If you have metastatic CRPC, ask your doctor to be tested for AR-V7 to see if you are eligible to participate in the ARMOR3-SV clinical trial of galeterone.

If you are interested in participating in ARMOR3-SV, or have additional questions, talk to your doctor, or visit www.clinicaltrials.gov (Study Identifier: NCT02438007) for more details. Or visit http://tokaipharmaceuticals.com/patients-and-physicians/armor3-sv/


 

 

ARAMIS

A clinical research study for patients with prostate cancer that has not spread beyond the prostate

Bayer HealthCare is seeking men who have prostate cancer to participate in a research study of an investigational drug. The purpose of the ARAMIS trial is to determine the safety and effectiveness of an investigational drug in delaying prostate cancer spreading from the prostate. This study is enrolling patients with prostate cancer that is at risk of progressing, but has not already spread to other areas of the body. Eligible patients must have rising prostate specific antigen (PSA) values without spread of their prostate cancer to other areas of the body.

If you are currently receiving hormone therapy, your treatment will continue and in addition you will receive either the investigational medication or placebo. Two out of every 3 patients will receive investigational medication and the assignment to the medication will be random.

To learn more about the ARAMIS trial and to find out if you may be eligible, please visit: http://www.bayerpharma.com/en/research-and-development/clinical-trials/trial-finder/index.php (Trial Number: 17712) or www.clinicaltrials.gov (Study Identifier: NCT02200614)


 

 

The SPARTAN Study

A clinical research study for patients whose prostate cancer has not spread beyond the prostate is now enrolling

Aragon Pharmaceuticals is seeking men to participate in a clinical trial of an investigational drug for prostate cancer. The purpose of the SPARTAN study is to evaluate the safety and effectiveness of an investigational drug in delaying prostate cancer from spreading beyond the prostate. This study is enrolling patients with prostate cancer who, despite treatment, have rising blood prostate-specific antigen (PSA) levels. All participants will continue to receive their current treatment along with either the investigational medication or a placebo. The selections will be random, and the investigational medication will be given to 2 out of every 3 study participants.

To learn more about the SPARTAN Study and to find out if you may be eligible, please visit: SPARTAN Study or www.clinicaltrials.gov
Study Identifier: NCT01946204

Aragon Pharmaceuticals, Inc.
Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson and provides various services to its affiliate, Aragon Pharmaceuticals, Inc.


ERA 223

A clinical research study for patients with asymptomatic/mildly symptomatic castration resistant prostate cancer and two or more bone metastases Bayer HealthCare is seeking men to participate in a research study of radium-223. The purpose of the ERA 223 trial is to determine if the addition of radium-223 to abiraterone acetate is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as bone fractures or bone pain which needs to be treated with an X-ray machine. This study is enrolling patients with prostate cancer who, despite medical or surgical castration, have rising blood prostate-specific antigen (PSA) levels. Eligible patients must have two or more bone metastases with no visceral, e.g. liver, metastases and must not have received prior chemotherapy. Prostate cancer lesions must be asymptomatic or mildly symptomatic.

All patients will receive abiraterone acetate along with either radium-223 or placebo.

To learn more about the ERA 223 trial and to find out if you may be eligible, please visit: http://www.bayerpharma.com/en/research-and-development/clinical-trials/trial-finder/index.php (Trial Number: 15396) or www.clinicaltrials.gov (Study Identifier: NCT02043678)


Augmenix is seeking men to participate in a US clinical trial testing the safety and effectiveness of SpaceOAR System, an investigational medical device. The purpose of this study is to evaluate the safety and effectiveness of an investigational device, the SpaceOAR System, in radiation therapy to treat prostate cancer. It is being studied to see if it can successfully move the rectum away from the prostate. By separating the rectum from the prostate the SpaceOAR gel may eliminate or reduce damage to the rectum from radiation therapy.

To learn more about this study, please visit Augmenix


Safety and Anti-Tumor Study of Oral EPI-506 for Patients With Metastatic Castration-Resistant Prostate Cancer

The study will consist of 2 parts: Part I (Dose Escalation) and Part II (Dose Expansion). In Part I, patients will participate in single, multiple, and long-term dosing periods using EPI-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary indications of anti-tumor activity. Part I is an open-label, adaptive 3 + 3 design, dose-escalation study. Up to six dose levels of EPI-506 will be studied, beginning at 80 mg/day. Patients may be allowed to escalate sequentially to a higher dose cohort after twelve weeks of dosing.

In Part II, 3 patient populations; post-abiraterone metastatic castration-resistant prostate cancer (mCRPC) but enzalutamide-naïve, post-enzalutamide mCRPC but abiraterone-naïve, and post-abiraterone and enzalutamide mCRPC will be studied at the recommended Phase 2 dose (RP2D) determined in Part I over 12 weeks of daily dosing. Approximately 120 patients (40 in each cohort) will be enrolled.

To learn more about this study and to find out if you may be eligible, please visit:https://clinicaltrials.gov/ct2/show/NCT02606123?term=EPI-506&rank=1

 


Additional open trials can be found by going to:


 

 

 

 

 

 

 

 

 

Literature:

 Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials

Tomasz M. Beer, MD
Larry Axmaker, Ed.D.

Written from both a patient and clinician perspective by Larry Axmaker, Ed.D., and Tomasz M. Beer, MD, a PCF-funded researcher, this book is an insightful resource for anyone considering clinical trials in addition to standard cancer therapy. Order Here »

 

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