A Phase III Double Blinded Study of Early Intervention after RADICAl ProstaTEctomy with Androgen Deprivation Therapy with Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE)

Date Added
November 29th, 2021
PRO Number
Pro00116694
Researcher
Robert Grubb

List of Studies


Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for men with prostate cancer with high risk disease. The purpose of this study is to see if the addition of a new drug, darolutamide, to standard Androgen Deprivation Therapy (ADT) (a hormonal therapy that is a usual approach to treatment) after surgery cure more men with prostate cancer than using Androgen Deprivation Therapy alone.

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

PD-INHIBITOR (NIVOLUMAB) AND IPILIMUMAB FOLLOWED BY NIVOLUMAB VS. VEGF TKI CABOZANTINIB WITH NIVOLUMAB: A PHASE III TRIAL IN METASTATIC UNTREATED RENAL CELL CANCER [PDIGREE]

Date Added
November 17th, 2021
PRO Number
Pro00116463
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer/Genitourinary, Kidney
Summary

This study is for patients with advanced kidney cancer and the purpose is to see if by adding a drug called cabozantinib to another treatment after receiving the standard treatment can prolong their life.

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

A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers

Date Added
October 19th, 2021
PRO Number
Pro00115293
Researcher
Robert Grubb

List of Studies


Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for patients with prostate cancer. The purpose of this study is to find out of adding Sunphenon® 90D to normal treatment will lower the chance of the cancer growing.

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

Combination of Autophagy Selective Therapeutics (COAST) in Advanced Solid Tumors or Relapsed Prostate Cancer, a Phase I/II Trial

Date Added
October 19th, 2021
PRO Number
Pro00113440
Researcher
Michael Lilly

List of Studies


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

This study is for subjects that have been diagnosed with advanced solid cancer tumors or relapsed prostate cancer. The investigational drugs in this study are hydroxychloroquine, nelfinavir, metformin, dasatinib and sirolimus. The purpose of this study is to determine the safety and effectiveness of up to 5 study drugs used together for the treatment of cancer. Subjects can expect to be in this study for about 2.5 years.

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

A Phase III Randomized Trial of Eribulin (NSC #707389) with or without Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

Date Added
September 17th, 2021
PRO Number
Pro00114367
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer/Genitourinary, Urinary
Summary

This study is for patients with urothelial bladder cancer that has spread to other parts of the body. The purpose is to see if patients can live longer if they are treated with a new drug alone, a new drug in combination with one of the usual chemotherapy drugs or the usual chemotherapy drugs by themselves.

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

A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

Date Added
August 27th, 2021
PRO Number
Pro00113791
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Urinary
Summary

This study is for patients with upper urinary tract cancer. The purpose of this study is to compare a usual treatment alone to using MEDI4736 (durvalumab) plus the usual treatment.

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

A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Date Added
February 23rd, 2021
PRO Number
Pro00106203
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have a tumor that cannot be removed through surgery (unresectable) or may have spread (metastasized) to other parts of their body. In this study, ASP1951 will be given alone (monotherapy) or combined with pembrolizumab (combination therapy). Both ASP1951 and pembrolizumab will be considered study drug. Pembrolizumab has been approved by FDA for use in patients with skin, lung, cervical cancer, certain cancers of head and neck and other cancers but may not be approved to treat all types of cancer. However, the use of ASP1951 plus pembrolizumab has not been approved by regulatory authorities and is therefore investigational. The study consists of 3 periods: screening (up to 28 days), treatment (up to 48 weeks [16 cycles]) and follow up (up to 45 weeks), followed by an optional re-treatment period for participants that qualify. The re-treatment period will allow participants to receive study drug treatment again for up to 16 additional cycles (approximately 48 weeks), for a maximum total treatment and re-treatment period of 32 cycles (approximately 96 weeks). Both study drugs are administered intravenously (into the vein).This is the first time the investigational study drug ASP1951 is being tested in humans; however, studies in animals showed that the study drug is safe to be tested in humans.

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

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

InPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative study)

Date Added
September 1st, 2020
PRO Number
Pro00100404
Researcher
Robert Grubb

List of Studies


Keywords
Cancer/Genitourinary
Summary

This study is for men with penile cancer. The sponsor wants to see if they can improve the treatment of patients with penis cancer that has spread. The purpose of this study is to test treatments which might reduce the chances of the cancer coming back. Combinations of four different treatments are being studied:
• Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.
• Chemotherapy followed by surgery.
• Chemotherapy combined with radiotherapy followed by surgery.
• Surgery to remove the lymph nodes in the groin and also lymph nodes further away from where the cancer first appeared (deeper in the pelvis).

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



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