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Clinical Research

Urology of Indiana 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.

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For more information on our clinical trials, please call our Clinical Research Department at 317-564-5573.

Clinical Trials At Urology of Indiana

Bladder Cancer

Moonrise 3

NCT06919965 (Open for enrollment)

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator’s choice of intravesical chemotherapy for treatment of high-risk non-
muscle-invasive bladder cancer (HR-NMIBC).

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Quilt: A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer | ClinicalTrials.gov

NCT02138734 (Open for enrollment)

QUILT-3.055 is a Phase 2b, open-label, multicohort study investigating
combination immunotherapies in patients with advanced solid tumors who have
previously been treated with PD-1/PD-L1 checkpoint inhibitors. The study aims to
evaluate the safety and efficacy of NAI (nogapendekin alfa inbakicept) in combination with other agents like checkpoint inhibitors and cell therapies across various cancer types and treatment settings. The study includes multiple cohorts
based on prior therapies and cancer types, with a focus on assessing overall response rate (ORR), overall survival (OS), and other measures of anti-tumor activity and immune response.

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CORE-008: Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC | ClinicalTrials.gov

NCT06567743 (Open for enrollment)

This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer. In Cohort B, up to 150 participants will be enrolled with pathologically confirmed, high-risk high-grade
NMIBC (i.e., CIS with or without concomitant Ta or T1 disease OR HG Ta/T1 disease without CIS) which has previously been exposed to BCG treatment. Participants with CIS-containing pathology at baseline will be recruited into Arm 1 and participants with papillary-only pathology at baseline will be recruited into Arm 2. Both Cohort B Arms 1 and 2 will receive cretostimogene via the alternative instillation procedure.

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Prostate Cancer

EvoPAR-02

NCT06952803 (Open for enrollment)

The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised/locally advanced prostate cancer with a breast cancer gene mutation (BRCAm).

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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).

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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).

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Bladder Cancer

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 for enrollment)

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).

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Sunrise-1: NMIBC BCG Unresponsive who are ineligible for or elected not to undergo RC

NCT04640623 (closed for enrollment)

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).

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Pivot-006: Intermediate Risk

NCT06111235 (closed 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.

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Patapsco: BCG in Combination with Durvalumab in Adult BCG-naïve, HR-NMIBC

NCT05943106 (closed 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.

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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 (closed 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.

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Engene

NCT04752722 (closed for enrollment)

This study will evaluate the safety and efficacy of intravesical administration of
EG-70 in the bladder and its effect on bladder tumors in patients with NMIBC. This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and patients with NMIBC with Cis who are BCG-naïve or inadequately treated.

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Moonrise 2

NCT05316155 (closed for enrollment)

The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder’s inner lining).

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BOND-003

NCT04452591 (closed for enrollment)

This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Cohort P(Japan and the United States Only):To determine the all-cause High Grade Event Free Survival (HG-EFS) of cretostimogene in up to 75 patients with BCG-unresponsive HG Ta/T1 papillary disease without CIS.BCG failure is defined as a persistent or recurrent disease within 6 months of completion of adequate BCG therapy.

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Prostate Cancer

Solar Recur: Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

NCT06235099 (closed 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.

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Optyx: A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX

NCT05467176 (closed 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.

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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 for enrollment)

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).

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Libertas: A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC

NCT05884398 (closed for enrollment)

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.

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Replace-CV: Relugolix Versus Leuprolide in Patients With Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events

NCT05605964 (closed for enrollment)

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Meet the Urology of Indiana Research Team

Eugene B. Cone, MD

Urologic Oncologist
Research Co-Director

Chad A. Reichard, MD

Urologic Oncologist
Research Co-Director

Sarah Faisal

Vice President of Research
U.S. Urology Partners
sarah.faisal@us-uro.com

Elizabeth Conley

Senior Research Coordinator

Sydney Manley

Senior Research Coordinator

Emily Jean-Baptiste

Study Coordinator

Hunter Dameworth

Study Coordinator

Nolan Espich

Study Coordinator

Aiden Hanson

Study Coordinator

Cydnie Jones

Study Coordinator