Biobank for African American Prostate Cancer Research in Florida

The purposes of this study are: a) to develop a statewide Biobank for prostate cancer among men of African Ancestry in Florida and; b) to examine whether smoking increases the aggressiveness of prostate cancer using several biological approaches.

Investigators plan to contact African American prostate cancer patients regarding participation. This project has 3 main components. Eligible patients may choose to participate in any or all parts of the study: Questionnaires; Saliva Samples; Tumor Tissue.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Questionnaires; Other: Saliva Samples; Other: Tumor Tissue

Detailed Description

This project will create the first state-wide data and biospecimen bank for men of African ancestry with prostate cancer. The sampling strategy and size of the study population ensure that the cohorts is representative, enhancing validity of studies based on this resource. In addition, there are no data on the role of smoking in African American prostate cancer. The approach to share the resource with Florida prostate cancer researchers is innovative and possible because the four annual prostate cancer symposiums organized by Moffitt has unified many Florida prostate cancer researchers who are now well connected and actively collaborating, as evidenced by publications and funded projects among participants.

• Study Type: Observational
• Enrollment (Actual): 592

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Men of African Ancestry in Florida who were diagnosed with prostate cancer between January 2013 and December 2015.

Description

Inclusion Criteria:

• The initial recruitment of cases will be done with 3 mailings: the first to introduce the study to the participant from Florida Cancer Data System (FCDS) of the Florida Department of Health and ask them to complete the eligibility form and contact information update form; a second mailing to those who are determined to be eligible for the study to obtain the Informed Consent Form and the Baseline survey; and a third mailing to those who completed the survey to obtain a saliva sample and medical release form for tissue.
• Histologically biopsy confirmed, primary prostate cancer, diagnosed between January 2013 and December 2015
• African American or Black; Hispanic Black; Afro-Caribbean
• Are at least 20 years old
• Are a resident of Florida
• Additional criteria may apply

Exclusion Criteria:

• Does not meet Inclusion Criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Complete Patient Data Records Collected at Three Years	The study timeline is up to 3 years to collect detailed patients' data, outcome information and bio-specimens from men of African Ancestry with prostate cancer (n=6,000), diagnosed between January 2013 and December 2015.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Impact of Smoking in Prostate Cancer Aggressiveness - All Participants	Rate of prostate aggressiveness according to the smoking status (never, former, current cigarette smoker, pipe/cigar smoker only) at the time of diagnosis. This smoking status can be dichotomized into current smoker and non-smoker.	Up to 3 years
Rate of Impact of Smoking in Prostate Cancer Aggressiveness - Current Smokers	Current smokers further will be classified according to the Pack-year which will be obtained from questionnaire.	Up to 3 years
Number of Participants with Genetic Markers for Smoking Aggressiveness	Occurrence of genetic changes associated with smoking and aggressiveness in prostate tumor samples. Investigators selected ~200 mutations identified in 12 prostate-cancer related genes (AR, ETS, TP53, PTEN, APC, BRAF, BRCA2, ATM, KRAS, SPOP, ERG and EGFR) based upon preliminary study and literature search. Investigators will perform mutation detection on randomly selected 200 patients and determine their association with aggressiveness and smoking.	Up to 3 years
Number of Participants with Epigenetic Markers for Smoking Aggressiveness	Occurrence of epigenetic changes associated with smoking and aggressiveness in prostate tumor samples. A customized panel of 384 CpG sites will be profiled. 384 candidate CpG sites were selected from 149 sites including 18 multiple differentially methylated regions (DMRs) identified in the preliminary study, 235 sites from previous literatures. Investigators will determine their association with aggressiveness and smoking.	Up to 3 years

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: James and Esther King Biomedical Research Program
• Investigators: Principal Investigator: Jong Park, Ph.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2017
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): January 23, 2024

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: biobank; biospecimen; prostate disease; prostatic neoplasm; prostate cancer in black males; smoking and the aggressiveness of prostate cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Behavior; Prostatic Neoplasms; Prostatic Diseases; Smoking; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: MCC-18643

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No