Clinical Trials

Staying at the Forefront Through Clinical Research

The newest treatment advances come through clinical research trials. By conducting these research trials, our patients have access to expert knowledge and promising treatments before they are widely available.

Your participation means you’ll receive regular and careful medical attention from AUI research teams including urologists and other medical specialists. And you’ll play an important role in advancing medicine.

Clinical Trial Sponsors

Partner with AUI for your next Clinical Research Trial. For details, call the number listed for each location.

Clinical Research Trials at AUI

Every clinical research trial described below follows strict guidelines to ensure your safety. Ask your doctor if there’s a trial that is right for you. Or call the number listed at the end of the group of trial descriptions for each location.

Daytona Region

Clinical trials for patients with Bladder Cancer:

PIVOT-006
GC Oncology

This is an open-label, Phase 3 study designed to assess the recurrence free survival rate (RFS) of TURBT followed by adjuvant Cretostimogene versus TURBT followed by observation for the treatment of participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC).

Clinical trials for patients with Prostate Cancer:

ECT2023-001 EPI-Bridging Study
Exosomedx

The purpose of this study is to evaluate workflow process improvements to the ExoDx prostate test using prospective urine collection in the intended use population.

Mdx Health – Confidence

The purpose of this study is to assess current clinical practices for managing patients with one or more cancer-negative prostate biopsies, and to determine the impact and clinical utility of Confirm mdx when used to manage these patients.

Dendreon P23-1
Dendreon Pharmaceuticals

NCT06134232

An Open-Label, Multicenter Study of Subjects with Metastatic Castrate-Resistant Prostate Cancer Treated with Provenge and Boosted with a Single Infusion of Sipuleucel-T to Measure Immune Response.

Learn More

For more information or to enroll in one of these trials, call our Daytona Clinical Research Department at 386-239-8535 or 386-236-2676.

Oxford Region

Clinical trials for patients with Prostate Cancer:

Mdx Health – Confidence

The purpose of this study is to assess current clinical practices for managing patients with one or more cancer-negative prostate biopsies, and to determine the impact and clinical utility of Confirm mdx when used to manage these patients.

Dendreon P23-1
Dendreon Pharmaceuticals

NCT06134232

An Open-Label, Multicenter Study of Subjects with Metastatic Castrate-Resistant Prostate Cancer Treated with Provenge and Boosted with a Single Infusion of Sipuleucel-T to Measure Immune Response.

Learn More

For more information or to enroll in one of these trials, call our Ocala Clinical Research Department at 352-504-4608.

Pinellas Region

Clinical trials for patients with Bladder Cancer:

CORE-008
G Oncology, Inc.

NCT06567743

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 (NMIBC) with Carcinoma In Situ. All patients with CIS are eligible. We will soon be able to include BCG refractory patients. We will let you know as soon as this arm in the study opens. Please counsel patients on the study at the time of the path review and send a Jellybean to Amy Franklin for review.

Learn More
PIVOT-006
GC Oncology

This is an open-label, Phase 3 study designed to assess the recurrence free survival rate (RFS) of TURBT followed by adjuvant Cretostimogene versus TURBT followed by observation for the treatment of participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC).

Clinical trials for patients with Prostate Cancer:

Ortho A&S
QuidelOrtho

Demonstrate higher % fPSA [(VITROS Free PSA III/ VITROS Total PSA III) x 100] is associated with lower probability of prostate cancer in subjects 50 years of age or older evaluated for prostate cancer that have prostate biopsy results, a total PSA value in the range of 4.0 to 10.0 ng/mL and DRE findings not suspicious for cancer. The VITROS Immunodiagnostic Products Free PSA III assay is for the quantitative measurement of free PSA in human serum and plasma using the VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System and VITROS XT 7600 Integrated System.

IsoPSA
Cleveland Diagnostics, INC

CDx2023-01B

A Non-Randomized Single-Blind Multi-Site Study for Supplemental Clinical Validation of the IsoPSA Assay in African Americans The IsoPSA® Assay is a diagnostic test system that evaluates total and free Prostate Specific Antigen (PSA) in IsoPSA Reagent-partitioned heparinized plasma samples and reports a single numerical score.

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Dendreon P23-1
Dendreon Pharmaceuticals

NCT06134232

An Open-Label, Multicenter Study of Subjects with Metastatic Castrate-Resistant Prostate Cancer Treated with Provenge and Boosted with a Single Infusion of Sipuleucel-T to Measure Immune Response.

Learn More

For more information or to enroll in one of these trials, call our Largo (Pinellas County) Clinical Research Department at 727-441-1508 ext 119.