A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer (COMPPARE)

Date Added
September 15th, 2020
PRO Number
Pro00102422
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

This study is for patients that have been diagnosed with prostate cancer. The purpose of this study is to directly compare photon (X-ray) therapy and proton therapy to determine which one has better disease control and fewer patient-reported and physician-reported side effects. Participants can expect to be in this study for a minimum of 3 years and up to 10 years, depending on funding.

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

PREEMPT CRC: PREvention Employing a Multiomics Plasma-based Test for ColoRectal Cancer

Date Added
June 22nd, 2020
PRO Number
Pro00099252
Researcher
Don Rockey

List of Studies


Keywords
Aging, Cancer/Other, Colonoscopy, Digestive System, Disease Prevention, Men's Health, Prostate
Summary

The Sponsor of this research study is trying to develop a new experimental diagnostic blood test that may help detect colorectal cancer and other diseases. A diagnostic test identifies a specific disease or condition. Experimental means the test has not received approval by the United States Food and Drug Administration (FDA) for sale.
The main goal of this research study is to collect health information and blood samples from people who are going to have a standard-of-care screening colonoscopy. The blood samples along with other health information from patients who take part in the study may help the Sponsor develop new diagnostic tests that may help detect cancer or other diseases in other patients in the future.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
bickfome@musc.edu

A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer

Date Added
March 10th, 2020
PRO Number
Pro00095193
Researcher
Michael Lilly

List of Studies


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

This study is for patients who are 18 years and older that have been diagnosed with metastatic castration-resistant prostate cancer (mCRPC).The investigational drugs in this study are Nivolumab and Ipilimumab.The purpose of this research study is to test the effectiveness (how well the drug works), safety, and tolerability of different dosing regimens containing nivolumab plus ipilimumab, ipilimumab alone, or cabazitaxel plus prednisone or prednisolone in participants with metastatic castration-resistant prostate cancer (mCRPC).Duration of this study will take approximately 24 months.

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

A Phase II Study of the Addition of Opaganib to Androgen Antagonists in Patients with Prostate Cancer Progression on Enzalutamide or Abiraterone

Date Added
January 21st, 2020
PRO Number
Pro00095537
Researcher
Michael Lilly

List of Studies


Keywords
Cancer/Genitourinary, Prostate
Summary

This is a phase II study that will look at the safety and effectiveness of the investigational drug opaganib in participants with metastatic prostate cancer. The study drug, opaganib has been studied in a clinical trial to find a safe dose level. The results of this clinical trial and other lab studies have indicated that opaganib may be effective at slowing tumor growth. Patients will be eligible to participate in this study if they have prostate cancer that has progressed (gotten worse) on their current therapy of either abiraterone or enzalutamide. Participants will received either 250mg or 500mg of opaganib by mouth twice a day. Patients will continue on study drug until the development of progressive disease, intolerable toxicity, withdrawal of patient consent or other event as outlined in patient discontinuation.

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

Clinical Protocol for the Investigation of the ProSpace™ Balloon System

Date Added
November 26th, 2019
PRO Number
Pro00094196
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Lymphoma, Men's Health, Prostate
Summary

The ProSpace balloon is being studied to test if it will temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating that space will reduce the radiation dose delivered to the anterior rectum. The ProSpace balloon is composed of a bioresorbable polymer material called RESOMER. RESOMER is well studied and approved for many indications. This study will show if it will maintain that space for the entire course of prostate radiotherapy treatment and then be completely absorbed by the body over time. The balloon is considered a permanent implant because it will remain in the body for at least 30 days. The ProSpace System study will collect data to demonstrate the safety and efficacy of its indication. This device is currently investigational in the United States

Institution
MUSC
Recruitment Contact
Sarah Mulhern
843-792-9321
hcc-clinical-trials@musc.edu

PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCER

Date Added
March 19th, 2019
PRO Number
Pro00086529
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

This study is for men who have prostate cancer. The purpose of this study is to compare the effects, good and/or bad, of adding either prostate removal surgery or radiation therapy of the prostate to standard systemic therapy (SST), which is used to treat prostate cancer.

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

PHASE III IGRT AND SBRT VS IGRT AND HYPOFRACTIONATED IMRT FOR LOCALIZED INTERMEDIATE RISK PROSTATE CANCER

Date Added
February 28th, 2018
PRO Number
Pro00075522
Researcher
David Marshall

List of Studies


Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for patients with prostate cancer that has a risk of getting worse. The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy.

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.

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

List of Studies


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

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High-Risk Prostate Cancer: A Phase III Randomized Trial

Date Added
September 17th, 2013
PRO Number
Pro00028856
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area to determine which is better.

There are 2 treatment groups in this study:
1) Patients who receive hormone therapy plus radiation therapy to the prostate gland and seminal vesicles
2) Patients who receive hormone therapy plus radiation therapy to the whole pelvis

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

A Phase III Prospective Randomized Trial Of Dose-Escalated Radiotherapy With Or Without Short-Term Androgen Deprivation Therapy For Patients With Intermediate-Risk Prostate Cancer

Date Added
August 19th, 2013
PRO Number
Pro00027510
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for patients with prostate cancer. The purpose of this study is to compare the effects of dose-escalated radiation therapy with or without hormone therapy on your prostate cancer.
There are 2 treatment groups in this study:
1) Patients who receive radiation therapy only
2) Patients who receive radiation therapy plus hormone therapy
Patients will receive 44 radiation treatments over approximately 2 months. If the patient chooses to receive the brachytherapy implant, he will receive 25 daily treatments plus the implant procedure over a timeframe of approximately 6 weeks. Hormone therapy, if given, will last 6 months. After patients are finished receiving therapy, the study doctor will ask them to visit the office for follow-up exams at 3, 6, 9, and 12 months after finishing radiation treatment, every 6 months for 4 years, and yearly thereafter.

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



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