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

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

List of Studies


Profiles_link
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 Save

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

List of Studies


Profiles_link
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 Save

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

List of Studies


Profiles_link
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

Study of Prostate Ablation Related Energy Devices (SPARED) Registry Save

Date Added
November 24th, 2019
PRO Number
Pro00094120
Researcher
Harry Clarke

List of Studies


Profiles_link
Keywords
Cancer, Prostate
Summary

This study is called a registry study. A registry study collects information about a group of people who have the same medical condition. This is not a treatment study. The type of prostate cancer treatment subjects received will be determined by the subject and their physician and will not be affected by their participation in this study. This research is being done is to create a comprehensive nationally-representative clinical database to facilitate the study of existing and emerging technologies for prostate cancer ablation. Ablation refers to the use of various energy sources to destroy both normal and cancerous prostate cells.

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

Influence of Primary Treatment for Prostate Cancer on Work Experience (PCW) Save

Date Added
November 18th, 2019
PRO Number
Pro00094342
Researcher
Chanita Hughes-halbert

List of Studies


Profiles_link
Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for African American men with prostate cancer. The purpose of this study is to see how prostate cancer treatment affects men's ability to work.

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

A preliminary study to investigate the unique needs to survivorship care in advanced-stage prostate cancer survivors. Save

Date Added
October 18th, 2019
PRO Number
Pro00091217
Researcher
Alejandra Schimmel

List of Studies

Keywords
Cancer/Genitourinary, Prostate, Stage III, Stage IV
Summary

This preliminary study proposes to explore the unmet survivorship care needs of advanced-disease prostate cancer survivors. The study will use a qualitative approach by giving this population the opportunity to voice their attitudes, perceptions, and preferences regarding their current survivorship care. The overarching goal is using these results to inform the need for a larger scale study in the future to increase the knowledge base regarding late-disease prostate cancer survivors.

Institution
MUSC
Recruitment Contact
Michael Lilly
843-792-0592
lillym@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 Save

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

List of Studies


Profiles_link
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

Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Patients With Favorable Intermediate-Risk Localized Prostate Cancer Following Cell Cycle Progression (CCP) Testing (Prolaris® Test) Save

Date Added
March 13th, 2019
PRO Number
Pro00085807
Researcher
Thomas Keane

List of Studies


Profiles_link
Keywords
Cancer, Prostate
Summary

The main purpose of this study is to find out if getting a test, called the Prolaris cell cycle progression test (CCP), changes decisions about how prostate cancer is treated and how these decisions affect the course of the disease. Researchers want to look at the treatments that men and their doctors choose to manage prostate cancer and how the treatments change over time.
This study is called a registry study. A registry study collects information about a group of people who have the same medical condition. This study will enroll men who have had Prolaris testing and men who have not had Prolaris testing. During the course of this registry study demographic and health information will be collected from you or from your medical records several times over the course of 8 years.
The Prolaris test would like to improve the impacts of individual risk assessment, as well as, to help researchers to better understand prostate cancer and how decisions are made about prostate cancer treatment.

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

A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist) Save

Date Added
August 21st, 2018
PRO Number
Pro00075705
Researcher
Thomas Keane

List of Studies


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

The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer and cardiovascular disease.

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

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