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

A Phase 2, Multicenter, Single-Arm Trial of CV301 in Combination with PD-1/L1 Blockade in Patients with Locally Advanced or Metastatic Urothelial Bladder Cancer Save

Date Added
January 8th, 2019
PRO Number
Pro00081883
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Bladder, Cancer, Drug Studies, Urinary
Summary

The purpose of this study is to is to investigate the combination of CV301 (an experimental cancer vaccine) with anti-PD-1 Therapy (atezolizumab which was approved for the treatment of advanced Urothelial Bladder Cancer) for treatment of locally advanced or metastatic UC.
CV301 involves the use of a two-component dosing regimen; a prime vaccine, MVA-BN-CV301 (the first vaccine generating a response from your immune system) and a boost vaccine, FPV-CV301 (the second vaccine increasing and maintaining the response of your immune system). Treatment with anti-PD-1 therapy may help the immune system detect and attack cancer cells.
In this clinical trial the use of CV301 vaccine in combination with atezolizumab infusion is being investigated to determine whether the overall survival and immune response observed in subjects treated with atezolizumab can be enhanced when combined with CV301.
This clinical trial is being performed at up to 8 clinical trial sites, and 68 people in total will be selected to participate. The trial is scheduled to last up to 104 weeks from the time you are first seen at the trial site until you start the long-term follow-up contacts. Once deemed eligible for participation, visits are every 3 weeks for the first 16 weeks on study. Then, visits will be every 6 weeks until week 28 on study, at which time visits will be every 12 weeks until end of treatment.
Participation in this trial will not guarantee any direct or immediate benefit, but can help gain future knowledge about the treatment of UC that may be beneficial to others with this disease.

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

A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Cemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma Save

Date Added
March 7th, 2011
IRB Number
20167
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies, Urinary
Summary

The purpose of this study is to compare the effects, good and/or bad, of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab on you and your transitional cell cancer to find out which is better. Bevacizumab is an antibody that we think can block a protein called VEGF and inhibit the growth of new blood vessels. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal, lung, and breast cancer, but for transitional cell carcinoma, it is not FDA-approved and should be considered experimental.

Bevacizumab is the common name for the commercial drug Avastin. The bevacizumab used in this trial, however, is for use in research studies only and may be made at locations different from those where Avastin is made. Although some differences may exist, bevacizumab for research use and the commercial drug, Avastin, are manufactured by a similar process, meet similar standards for final product testing and are expected to be very similar in safety and effectiveness. The combination of gemcitabine and cisplatin is one commonly used treatment that has been shown to make some patients with transitional cell carcinoma live longer. This research is being done to see if adding bevacizumab to gemcitabine and cisplatin will delay the growth of your cancer and allow you to live longer.

This is a randomized trial so patients will receive one of two treatments: Arm A: Gemcitabine, cisplatin, and placebo (sugar water or salt water)OR Arm B: Gemcitabine, cisplatin, and bevacizumab (an experimental drug). Arm A is the current standard treatment for patients with this type of cancer. Your participation in this trial will continue for as long the cancer is responding to or is stabilized by the drugs and you do not have any severe side effects from the drugs.

Institution
MUSC
Recruitment Contact
Alan Brisendine
843-792-9007
matsont@musc.edu

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