Published: April 11, 2024

Clinical Trials We Are Currently Recruiting For – April 2024

By: Dr. Jason Hafron, M.D., CMO

We conduct clinical trials at MIU to better understand urological conditions and diseases. These trials help us find better ways to prevent and treat these illnesses, and participation in them can potentially grant patients access to the latest treatments available.

Every trial follows strict guidelines to protect participants. However, deciding whether to participate in a clinical trial is a significant decision, and we encourage patients to ask questions and seek guidance before making any decisions.

We are currently enrolling patients for the following clinical trials to treat these illnesses:

Prostate Cancer

Vapor-2 –The purpose of this study is to evaluate the safety and efficacy of the Vanquish Water Vapor Ablation Device (“Vanquish”) in treating subjects with Gleason Grade Group 2 (GGG2) localized, intermediate-risk prostate cancer.

Libertas – 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

Muscle Invasive Bladder Cancer

SunRISe-4 – 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.

Non-Muscle Invasive Bladder Cancer

SunRISe-1 – 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)

KEYNOTE – A Phase 3, Randomized, Comparator-controlled Clinical Trial to study the efficacy and safety of Pembrolizumab (MK-3475) in combination with Bacillus Calmette-Guerin (BCG) in participants with High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) that is either persistent or recurrent following BCG Induction or that is naïve to BCG Treatment (KEYNOTE-676)

Patapsco – 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.

Benign Prostate Hypertrophy (BPH)

Butterfly – A Prospective, Randomized, Controlled, Blinded Study to Assess the Safety and Efficacy of the Butterfly Medical Prostatic Retraction Device in BPH Patients

To learn even more about clinical trials, visit the National Institutes of Health and ClinicalTrials.gov. These resources provide an excellent overview of the basics of clinical trials and information about ongoing clinical studies worldwide. Most importantly, talk to your doctor to determine if a clinical trial is right for you.

For more information on clinical trials at MIU, you can also contact our Research Department at  (248) 786-0467 or email research@michiganurology.com.

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