Services
Clinical Research
Participation in clinical trials research enables Urology of Indiana physicians to provide their patients with direct access to cutting-edge advances in medical technology and pharmaceutical development.
Before a new medical treatment can be marketed, manufacturers must show, through adequate and well-controlled clinical studies, that it is safe and effective. Participation in clinical research trials enables our physicians to gain insight and experience in many areas of leading-edge technology and pharmaceutical development. Our contribution to significant advances in the area of urologic and genitourinary research is in keeping with our mission to bring the newest and most advanced treatments and procedures to our patients.
Research trials at Urology of Indiana are conducted with the highest level of honesty and integrity. While contributions to a patient’s health and well-being are important, patient safety and privacy are our priorities.
Get More Information
For more information on our clinical trials, please call our Clinical Research Department at 317-564-5573.
Meet the Urology of Indiana Research Team
Sarah Faisal
Vice President of Research
U.S. Urology Partners
sarah.faisal@us-uro.com
Brittiny Currin
Research Supervisor
Elizabeth Conley
Study Coordinator
Sydney Manley
Study Coordinator
Clinical Trials At Urology of Indiana
Bladder Cancer
Pivot-006: Intermediate Risk
NCT06111235 (Open for enrollment)
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by observation for the treatment of participants with IR-NMIBC.
Patapsco: BCG in Combination with Durvalumab in Adult BCG-naïve, HR-NMIBC
NCT05943106 (Open for enrollment)
The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed diagnosis of high-risk non-muscle-invasive bladder cancer (NMIBC), who have received no prior systemic therapy for NMIBC, and who are BCG-naïve.
Able-41: Adstiladrin: Early Utilization and Outcomes in the Real World Setting in the United States
NCT06026332 (Open for enrollment)
Multi-center, prospective non-interventional study to collect data on the early use of ADSTILADRIN in the US. Data will be collected from participants, caregivers and prescribing physicians in a real-world setting.
Sunrise-5: A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-
Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
NCT06211764 (Open for enrollment)
The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator’s choice of single agent intravesical chemotherapy.
Sunrise-4: A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
NCT04919512 (Open for enrollment)
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.
Sunrise-3: A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)
NCT05714202 (Closed)
The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).
Sunrise-1: NMIBC BCG Unresponsive who are ineligible for or elected not to undergo RC
NCT04640623 (Closed)
The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).
Prostate Cancer
Solar Recur: Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer
NCT06235099 (Open for enrollment)
This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with recurrent prostate cancer after radical prostatectomy or radiation therapy.
Solar Stage: Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
NCT06235151 (Open for enrollment)
This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.
ProvONE: Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One
Infusion of Sipuleucel-T
NCT06134232 (Open for enrollment)
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Merck-004: A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA
NCT06136650 (Open for enrollment)
The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA).
Optyx: A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
NCT05467176 (Open for enrollment)
This is a multi-center, prospective, observational study of patients being treated with ORGOVYX. The goal of this study is to generate real-world evidence about the safety and effectiveness of ORGOVYX in patients with prostate cancer in routine clinical care and the clinical course during treatment with and following cessation of ORGOVYX.
Amplitude: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus
Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer
(mCSPC)
NCT04497844 (Closed)
The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).
Libertas: A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With
mCSPC
NCT05884398 (Closed)
The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level < 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.
Replace-CV: Relugolix Versus Leuprolide in Patients With Prostate Cancer: A Randomized, Open-Label
Study to Assess Major Adverse Cardiovascular Events
NCT05605964 (Closed)