Research Projects


A validation study on the impact of Decipher test (GC) on treatment recommendation in African American and Non-African American men with prostate cancer - VanDAAM  

Prostate cancer (PCa) has greatest incidence and mortality among African American men (AAM) as compared to European American men (EAM) in the US. Genomic factors have been linked to aggressive disease in AAM. Using an assay known as the genomic classifier (GC) test, also known as the  Decipher® test, we are now able to determine which tumors have very aggressive tendencies with high risk of metastasis. The test was initially developed from samples derived mainly from men of European origins and little is known about its performance in AAM. Our study sought out to assess whether this test can be used in AAM who are known to experience the highest rates of prostate cancer as well as death from prostate cancer. The use of the Decipher® test result to predict how well a patient will do before treatment may make it possible for doctors to distinguish aggressive disease from low-risk prostate cancer and modify treatment accordingly.

This prospective, multisite, matched cohort trial was designed to enroll 240 patients with prostate cancer (120 AAM & 120 EAM). Patients with low, and intermediate risk PCa were to be enrolled and receive Decipher testing from their already obtained biopsy tissue and again for their prostatectomy tissue (as applicable). Patients PSA and quality of life were then followed for 2 years post treatment completion to assess biochemical recurrence.



Applications of Clinical Genomics in Prostate Cancer Patients Post-Biopsy or Prostatectomy with or without Adjuvant or Salvage Radiation (GRID)

With the goal of improving the future of diagnosis and treatment, this research study seeks to examine the biological markers of prostate cancer. Collaborating with various institutions across the nation, this observational study aims to build a large genomic research database that can be used to enhance the treatment prostate cancer patients may receive. With this database, researchers hope to find novel biomarkers that may be contained within the genome and assess their influence on disease progression. Understanding these relationships could influence treatment recommendations, with an attempt to prevent overtreatment and toxicities that may be seen with different regimens.




The utility of PSMA-PET imaging for detecting early metastatic prostate cancer in men with high GC Decipher® test scores: A sub-aim of the VANDAAM study (MCC #18523)

Prostate Specific Membrane Antigen (PSMA), an enzyme that is expressed on 90% of prostate cells and its expression increases in advanced stage cancers. PSMA-PET imaging may improve the ability to detect early metastatic disease in patients with a high tumor genomic risk of metastatic disease at 5 years post-treatment. There is very little information concerning which patients will benefit most from PSMA-PET imaging, as such routine use of this imaging modality is not warranted. Once metastatic disease declares itself then the use such a test is less relevant. Therefore, it will be important to identify the patient population that can benefit from an imaging modality that can potentially alter treatment recommendations. Primary goal of this project is to evaluate the usefulness of using 18F-DCFPyL in detecting recurrent/metastatic prostate cancer. The ability to utilize Genomic Classifier (GC) information to stratify patients who might benefit from PSMA-PET imaging and to tailor treatment accordingly will be of immense clinical implications. This study was designed to enroll a total of 60 patients, previously enrolled to the VanDAAM study, with high GC scores (Decipher GC score >0.45). Each patient would obtain PSMA-PET scans annually for four years and followed to assess outcomes.



The Combination of Nivolumab Immunotherapy with Radiation Therapy and Androgen Therapy in the Management of Gleason Group 5 Prostate Cancer (a phase I & II clinical trial)

Poor outcomes have been reported for men with Gleason Group 5 Prostate Cancer who receive standard of care therapy. Evidence suggests that high dose rate brachytherapy (HDR) and androgen depravation therapy (ADT) can serve as immune modulators. For this study, we partnered with Bristol-Myers Squibb (BMS) to conduct a clinical trial. Where we test safety, tolerability, and effectiveness of the investigational drug nivolumab (Opdivo™) in combination with high dose radiation. Study team also want to see if these study drugs help to delay the progression of prostate cancer.



The Patient Derived Explant (PDE) Protocols

Our laboratory is working to yield patient derived explants from fresh prostate tissue obtained from men undergoing a Radical Prostatectomy (RP) as their first line treatment for Prostate Cancer (PCa). There are known variations in genetics and molecular tumor profiles for men of African American origin and these may also influence response to several known targeted therapies. Our goal with the PDEs is to study the biological, molecular, and/or genetic differences present between African American men (AAM) and European American Men (EAM), and also within the AAM population. It is necessary to discover and study molecular biomarkers of drug sensitivity to ensure an accurate treatment of AAM patients with PCa. Following classification of the explants, we will be treating them with different drugs according to their distinct molecular subtypes. Additionally, we will also study the metabolic disparities present in AAM, including the difference in treatment responses for these patients based on distinct metabolite consumption profiles.


The Ghana IntegRative Approach to Cancer ResEarch Training: The Grace Program

Cancer incidence is significantly increasing in many sub-Saharan Africa countries necessitating a shift in training and research to address this growing problem. Years ago Ghana recognized this problem and identified cancer sites for prioritization for both research and clinical care in their National Cancer Control Plan. These cancers include breast (BCa), cervical (CxCa), head and neck (HNCa) and prostate cancer (PCa). To address the goals set forth in the national cancer plan Moffitt Cancer Center (MCC) faculty have been collaborating with the Korle-Bu Teaching Hospital within the University of Ghana (UG), and the Ghana College of Physician and Surgeons (GCPS) for the past five years to build collaborative research and cancer clinical care capacity. The overall goal of the GRACE program is to develop a new generation of multidisciplinary global cancer researchers by implementing programs that will strengthen and expand institutional capacity to broadly conduct cancer research. Ultimately, this project aims at cultivating a training program that serves as a bridge between academics, policy makers, and public health communities.


Deconvolute key biological drivers that define subsets of lethal prostate cancer in African American Men

This project sets out to identify and validate genomic-based biomarkers that can predict aggressive lethal PCA in men of African American origin. There are notable molecular differences between African American Men (AAM) and European American Men (EAM) as it relates to lethal prostate cancer and studying these variances can provide clear indication on the biology that drives them. To evaluate these differences, we will be investigating how molecular pathways and immunological features affect the biology of lethal prostate cancer in AAM and develop a transcriptomics web resource that will aid in facilitating health disparity research for men with prostate cancer.