SUMMER 2022 CLINICAL CORNER

Prostate Cancer: Going the Distance With UF Health

When Andy Farina was born, his mother was told he would never walk.

Nearly six decades, five children and infinite support later, he is running ultramarathons.

His doctors often deemed him their “healthiest patient” — at least until his annual physical reported elevated levels of prostate-specific antigens, or PSA. Alarmed by this unexpected outcome, Andy tried alternative therapies to decrease his levels for two years. They didn’t budge, so he got an MRI.

“The MRI showed a lesion on the prostate. I knew I was in trouble,” Andy said. “I searched for someone like Dr. (Wayne) Brisbane, who is on the cutting edge, and Dr. (Li-Ming) Su, who is a highly experienced surgeon, for my treatment.”

Together, our UF Health urologists formulated a personalized approach to not only help Andy, but to do so in a way that was also safe and effective.

The result was a transperineal biopsy, an innovative procedure that shows potentially cancerous lesions on the prostate by entering through the skin that overlies the prostate, as opposed to the traditional rectal route. As a leader in image-guided biopsies, Brisbane believes healing begins with an accurate diagnosis.

Unfortunately, no amount of training could have prepared the ultramarathon runner for the biopsy’s result: prostate cancer.


New Clinical Trials Open for Enrollment

Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission

A Phase 2, open-label, non-randomized study evaluating the safety of administering high dose cytarabine (HiDAC) consolidation therapy on days 1-3 of each cycle, as compared to standard administration on days 1, 3, & 5 of each cycle, in patients 61 years or older with acute myeloid leukemia (AML).

Principal Investigator: Jack Hsu, M.D. | Cell: 352-672-0704


A Phase II Randomized Therapeutic Optimization Trial for Subjects With Refractory Metastatic Colorectal Cancer Using ctDNA: Rapid 1 Trial

A Phase 2, randomized study that investigates the use of the Signaterra ctDNA assay versus the standard scan-based approach to guide treatment in patients with metastatic colorectal cancer. The aim of this study will be to measure and compare the overall survival, progression-free survival, and best overall response while on study of patients whose treatment has been guided by these two approaches.

Principal Investigator: Sherise Rogers, M.D. | Cell: 718-614-5727 


A Dose Finding Phase 1 of Sarilumab plus Capecitabine in HER2/neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab plus Capecitabine in Stage I-III Triple Negative Breast Cancer with High-Risk Residual Disease

Patients with locally advanced TNBC are at high risk of developing lethal metastatic disease within 2 years of diagnosis, especially for those without a pathologic complete response (pCR) after neoadjuvant chemotherapy. This study will advance a novel and potent strategy to eliminate minimal residual disease (MRD) in triple negative breast cancer (TNBC) present even after multimodal treatment, thereby improving survival and increasing cure rate in this aggressive cancer. 

Principal Investigator: Karen Daily, D.O. | Cell: 352-222-1423


Measuring the Effects of Talazoparib in Patients with Advanced Cancer and DNA Repair Variations

This disease-agnostic, Phase 2 trial tests the PARP inhibitor Talazoparib (a highly selective and potent inhibitor that also provides significant PARP trapping activity) in advanced stage cancers with mutations to DNA damage response genes. Blocking the PARP protein abrogates a major DNA repair pathway, resulting in ineffective DNA repair mechanisms and encouraging apoptosis in tumor cells. Patients with advanced solid tumors may be eligible with any of the following germline or somatic dDDR mutations: BRCA1/2 (including those previously treated with a different PARPi), ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, and RAD54L, as well as loss of function in any of the Fanconi anemia genes (FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN).

Principal Investigator: Thomas George, M.D. | Cell: 352-339-6672