A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study) Save

Date Added
September 7th, 2019
PRO Number
Pro00090813
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed to have metastatic Castration-resistant Prostate Cancer (mCRPC). The purpose of this study is to find out if experimental medication called olaparib in combination with approved drug called abiraterone, will work and be safe for the treatment of the disease (mCRPC). Olaparib is a type of drug called a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor. Olaparib (tradename Lynparza™) is approved, by the US Food and Drug Administration (FDA) and other countries for the treatment of certain types of ovarian cancer and breast cancer. Abiraterone is already an approved medication for the treatment of some subjects with prostate cancer. This medication is indicated in combination with prednisone or prednisolone for the treatment of mCRPC. The research study is planned to go on for approximately 4 years, with visits lasting three to six hours each. Olaparib, abiraterone, and prednisone are all taken orally.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Clonal Emergence and Regression During Radium-223 Therapy for Metastatic Prostate Cancer Save

Date Added
December 21st, 2018
PRO Number
Pro00081670
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer/Genitourinary
Summary

This study is for patients with metastatic prostate cancer receiving radium-223 as their standard of care therapy. The researchers will collect blood and urine samples from patients before, during and after the radium-223 therapy. The researchers will compare these samples to observe how the treatment has affected different cancer markers.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-cto-clinops@musc.edu

Phase 1b/2 Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Save

Date Added
November 20th, 2018
PRO Number
Pro00082574
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer/Genitourinary
Summary

The overall goal of this study is to identify a safe dose of the metabolic supplement, Chitosan that can help reduce AGE (advanced glycation endproducts) levels in patients with prostate cancer. Chitosan is a naturally occurring substance found in shellfish. This study will be using Chitosan prepared from the shells of cold-water shrimp. Chitosan is approved by the FDA for use in wound dressings and has been used in published clinical trials for weight loss but is not approved for the purposes of this study. AGEs are a type of metabolite, or substance, found in food and produced in the body. The researchers helping conduct this study have found a potential link between AGE levels and cancer. Participation in this study will require three study visits over the course of about 3 months. During these visits subjects will be asked to provide blood and stool samples as well as complete surveys about their quality of life.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-cto-clinops@musc.edu

A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer Save

Date Added
September 25th, 2018
PRO Number
Pro00080886
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Prostate
Summary

The purpose of this research study is to determine the effectiveness and safety of niraparib used in combination with JNJ-63723283 in the treatment of subjects with advanced prostate cancer. The study medication, niraparib and JNJ-63723283 are given in cycles, with each cycle lasting 28 days. You will continue study medication for as long as your disease does not appear to be getting worse based on assessments by your doctor.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

An Open-label Phase 1/2A Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TRC253, an Androgen Receptor Antagonist, in Patients With Metastatic Castration-resistant Prostate Cancer Save

Date Added
September 26th, 2017
PRO Number
Pro00067101
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer/Genitourinary, Drug Studies
Summary

This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in which eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will receive oral doses of TRC253. The estimated completion date is September 2018.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Phase II Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy Save

Date Added
November 15th, 2016
PRO Number
Pro00059559
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer/Genitourinary
Summary

The purpose of this study is to identify a safe pharmaceutical agent that can reduce the AGE levels in subjects with advanced cancer. The term "AGE" (advanced glycation endpoints) refers to sugar-derived metabolites that are linked to lifestyle choices and can contribute to cancer.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-cto-clinops@musc.edu

A Phase II Trial of Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse after Radical Prostatectomy Save

Date Added
May 24th, 2016
PRO Number
Pro00054476
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer/Genitourinary, Prostate, Vaccine
Summary

This study is for adult male patients who have recently undergone radical prostatectomy and are at high risk for relapse. The purpose of this study is to look at the effect PROSTVAC-V/F has in preventing or prolonging relapse after surgery. PROSTVAC-V/F is an investigational drug. Subjects will have screening tests to determine eligibility. If the subject is eligible and wishes to enroll, he will begin study drug and will have drug administered at designated intervals over about 20 weeks . After the 20 week period, the subject will enter a follow up period for about a year and a half. The total amount of time on study is anticipated to be about 2 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer. Save

Date Added
April 28th, 2014
PRO Number
Pro00034803
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for patients that have prostate cancer that has spread and 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.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

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