Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Date Added
August 5th, 2022
PRO Number
Pro00122143
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for men with prostate cancer that has come back after surgery. This study is being done to see if PET/CT scans help provide more tailored treatment recommendations and outcomes for men who have prostate cancer after radical prostatectomy (RP) and will adding focal, metastasis directed radiation treatment (e.g.., stereotactic radiation) and/or additional systemic therapy (e.g., apalutamide) to standard of care treatment help to delay progression of prostate cancer in men who have already had an RP and now have recurrence?

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

T-reg function changes: a novel immune regulatory effect underlying benefit of statin use on lethal prostate cancer

Date Added
June 21st, 2022
PRO Number
Pro00120567
Researcher
Michael Marrone

List of Studies

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

This study is for subjects that have been diagnosed with prostate cancer that can be removed by surgery. The purpose of this study is to determine whether a group of drugs called statins can help to reduce the risk of prostate cancer returning after surgery. The drug used in this study is a particular type of statin called simvastatin. Simvastatin is approved by the Food and Drug Administration (FDA) to help lower cholesterol (fatty deposits in your blood) and decrease the risk of heart disease. Its use in this research study is considered investigational, and not FDA approved for the subject's cancer. Subjects can expect to be in the active participation portion of this study for about 3 months. Afterwards, the study team may contact them or their medical providers every 6 months to follow their cancer care and collect information on their current health status.

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

Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)

Date Added
March 29th, 2022
PRO Number
Pro00116642
Researcher
Theodore Gourdin

List of Studies


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

The study is for patients that have been diagnosed with invasive urothelial carcinoma (cancer of the bladder [UBC] or cancer of the upper urinary tract [UTUC]), and had the cancer removed surgically. The investigational drug used in this study is infigratinib or placebo. The main purpose of this study is to to determine whether patients who have undergone surgery to remove invasive urothelial cancer that has a genetic abnormality (changes in tumor's DNA) in the Fibroblast Growth Factor Receptor 3 (FGFR3) gene who receive the investigational drug infigratinib for one year remain cancer free compared with those who recThe total length of time you will participate in the study depends on how you respond to the study drug and how long other participants remain in the study. After this study is completed, you will be offered to participate in a long-term follow up study. ive placebo for one year. Participants can expect to be in this study for up to 4 years.

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

Parallel Phase III Randomized Trials of Genomic Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

Date Added
February 7th, 2022
PRO Number
Pro00118666
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for men with unfavorable intermediate risk prostate cancer, a low gene risk score and plan to receive radiation therapy with hormone therapy. The purpose of the study is to answer to find out if radiation therapy alone is as effective at controlling the cancer compared to the usual combination of radiation and hormone therapy. The study is also going to determine if adding another new hormone therapy drug to the usual combination of radiation and hormone therapy increase the length of time without the prostate cancer spreading compared to the usual treatment.

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

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



-- OR --