Clinical Trials We Are Currently Recruiting For – January 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.

If you want to learn more about clinical trials, we recommend visiting 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.

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.

Primordium – The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate-specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

Arastep – The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo and ADT given for a pre-specified duration of 24 months.

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

Interstitial Cystitis/Bladder Pain Syndrome

Ironwood – The aim of this study is to assess whether IW-3300 is safe and works for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). The main question the study aims to answer is whether IW-3300 helps bladder pain and other symptoms (for example, bladder burning, pressure and discomfort). Subjects will be assigned to receive either the study drug or placebo by chance.

For more information on clinical trials at MIU, contact Danielle Osterhout at (248) 786-0467 or email osterhoutd@michiganurology.com.

Tags:
Share this post:
Share on facebook
Share on twitter
Share on pinterest