GAIN-BCG: Gemcitabine Alternating With Intravesical BCG Randomized Against BCG Alone For Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer

Date Added
October 28th, 2025
PRO Number
Pro00147104
Researcher
Robert Grubb

List of Studies


Keywords
Cancer/Genitourinary, Drug Studies
Summary

This study is for people with high-risk, non-muscle invasive bladder cancer that has returned after treatment with BCG. Your cancer either did not fully respond to BCG or came back after initially responding, which is called BCG-exposed NMIBC. The purpose of this study is to find out if adding a chemotherapy drug called gemcitabine, given directly into the bladder through a catheter, to BCG works better than BCG alone. In this study, you will either receive BCG alone for up to 6 weeks or gemcitabine plus BCG for up to 10 weeks, called induction therapy. If the treatment is effective, you may continue with maintenance therapy, which is either BCG alone or gemcitabine plus BCG given over several weeks. After treatment, your doctor will monitor you for 5 years with regular checkups, cystoscopies, and CT scans to watch for side effects or recurrence. The main risks are that the study treatment may not work as well as usual care, and it may cause side effects such as pain with urination, urinary urgency, blood in the urine, bladder inflammation, or urinary tract infection. There may also be risks that study doctors do not yet know about.
There will be a total of 17 patients enrolled locally over the course of 42 months.

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

A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge

Date Added
October 8th, 2025
PRO Number
Pro00144193
Researcher
Theodore Gourdin

List of Studies


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

This study is for male subjects that have been diagnosed with metastatic prostate cancer (that has spread to other parts of the body) and progressed following standard hormonal/radiation therapy and surgery. Subjects are expected to remain in the study for a minimum of 48months or longer. There will be a total of 10 subjects locally enrolled.

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

A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel Formulation of UGN-101, for the Treatment of Patients With Low-grade Upper Tract Urothelial Cancer (LG-UTUC)

Date Added
September 3rd, 2025
PRO Number
Pro00145445
Researcher
Matvey Tsivian

List of Studies

Keywords
Cancer/Genitourinary, Drug Studies
Summary

This study is for subjects that have been diagnosed with low-grade upper tract urothelial cancer (LG-UTUC). This study is to evaluate the tumor ablative effect of the study drug (UGN-104). Subject are expected to reman in the study for a minimum of 15months or longer.

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

SHORT TERM INTENSIFIED PEMBROLIZUMAB (KEYTRUDA) AND TIVOZANIB FOR HIGH-RISK RENAL CELL CARCINOMA - STRIKE

Date Added
August 12th, 2025
PRO Number
Pro00146260
Researcher
Thai Ho

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

This study is patients that have been diagnosed with high-risk renal cell carcinoma. This study will compare disease free survival (DFS) in patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone. Participants can expect to remain in the study for 10years. There will be a total of 14 patient enrolled locally.

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

Genetic Registry for Upper Tract Urothelial Carcinoma

Date Added
August 6th, 2025
PRO Number
Pro00146501
Researcher
Matvey Tsivian

List of Studies

Keywords
Cancer/Genitourinary
Summary

This research study is for adult patients diagnosed with Upper Tract Urothelial Carcinoma (UTUC). The purpose of this study is to determine how often genetic variants are found in patients with UTUC. As part of this research study, the research team will collect health information about you from your medical record and blood, saliva, and tissue samples will be collected for genetic testing.

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

A RANDOMIZED PHASE III CLINICAL TRIAL FOR THE ADDITION OF DOCETAXEL TO ANDROGEN RECEPTOR PATHWAY INHIBITORS IN PATIENTS WITH METASTATIC CASTRATION SENSITIVE PROSTATE CANCER AND SUBOPTIMAL PSA RESPONSE (TRIPLE-SWITCH)

Date Added
June 20th, 2025
PRO Number
Pro00144119
Researcher
Kevin Becker

List of Studies

Keywords
Cancer/Genitourinary, Drug Studies, Prostate
Summary

This study is for subjects that have been diagnosed with prostate cancer. Subjects can expect to remain in the study for up to 39 months or longer. There will be a total of 16 enrolled locally. The study is set to enroll subjects for 39 months.

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

NRG-GU013: The Phase III ‘High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer

Date Added
June 20th, 2025
PRO Number
Pro00145135
Researcher
David Marshall

List of Studies


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

This study is for patients that have been diagnosed with prostate cancer. This study will compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (stereotactic body radiation therapy [SBRT]) to those randomized to moderate hypofractionation and conventional fractionation. Participants can expect to remain in the study for 11 years and 10 months.

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

Autophagy Maintenance (AUTOMAIN) Therapy in High-Grade Serous Ovarian Cancer: A Phase II Trial

Date Added
May 20th, 2025
PRO Number
Pro00143653
Researcher
Brian Orr

List of Studies

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

This study is for patients that have been diagnosed with ovarian cancer who are taking bevacizumab. This study is testing two investigational drugs called nelfinavir and hydroxychloroquine. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of cancer. The primary purpose of this study is to see if these two medications in combination with bevacizumab are safe and effective in ovarian cancer. These drugs will be given by mouth. Participants in this study can expect to be in this study for 6 months for data collection, but may continue on the study medications longer if seeing benefit.

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

A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer

Date Added
April 2nd, 2025
PRO Number
Pro00142948
Researcher
Theodore Gourdin

List of Studies


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

This study is for patients that have been diagnosed with metastatic castration-resistant prostate cancer. The study is testing an investigational drug called JANX007. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX007 when administered as a single agent. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study until disease progression or unacceptable toxicity.

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

MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of Adjuvant Therapy in Urothelial Cancer

Date Added
December 6th, 2024
PRO Number
Pro00137019
Researcher
Theodore Gourdin

List of Studies


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

This study utilizes adjuvant therapy in patients identified with urothelial cancer. Patients will be tested and screened to determine eligibility. Once they are deemed eligible and have consented to treatment, the study will begin. There are regular CT / MRI scans, blood draws, testing and drug administration that occurs while on this study, including while in post-treatment follow up. The study has seperated patients into Cohorts A and B. The study lasts approximately 5 years, with 2 years dedicated to regular treatment, and 3 to post-treatment follow up observation.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu



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