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

Silhouette
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

Randomized 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

Silhouette
Keywords
Cancer/Genitourinary
Summary

The purpose of this study is to identify safe pharmaceutical agents 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 Multi-center, Open Label, Randomized Phase 2 Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma Save

Date Added
August 9th, 2016
PRO Number
Pro00055991
Researcher
Michael Lilly

Silhouette
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Women's Health
Summary

The purpose of this study is to evaluate the progression free survival (PFS) , based on investigator radiologic review, of AGS-16C3F compared to axitinib in adult subjects with metastatic renal cell carcinoma. The time frame for PFS is 24 months.

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

Silhouette
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

Silhouette
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

EXOSOME-DERIVED BIOMARKERS FOR THE DIAGNOSIS AND MANAGEMENT OF PROSTATE CANCER (PCa) Save

Date Added
November 14th, 2012
PRO Number
Pro00019697
Researcher
Michael Lilly

Silhouette
Keywords
Cancer, Cancer/Genitourinary, Healthy Volunteer Studies
Summary

This study is for subjects with prostate cancer. The purpose of this study is to evaluate plasma (the liquid portion of blood) and urine samples from subjects diagnosed with prostate cancer, from subjects who are at high risk for prostate cancer but have not been diagnosed with the disease or subjects without a history of prostate cancer. These samples will be used to develop methods for isolating exosomes for evaluation and monitoring of prostate cancer. Approximately 10 mL (or 2 teaspoons) of blood and 30 mL (or 2 tablespoons) of urine will be taken from subjects no more frequently than twice per week up to six times over three years . These samples will be obtained during routine clinic visits. Healthy subjects will have only one blood draw at baseline and the collection will be obtained in a private location. Subjects may continue you on this study for 3 years. Clinic visits may take from 1 to 3 hours depending on clinic schedules.

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

Silhouette
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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