An observational study in Prostate Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to male participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Observational
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.
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.
Men of African Ancestry in Florida who were diagnosed with prostate cancer between January 2013 and December 2015.
Exclusion Criteria:
Participants will be asked to complete a baseline questionnaire that asks questions about their demographic information, medical history, and smoking habits when they first enroll in the study. They will also be asked to complete a follow-up questionnaire 2 years later. The questionnaires will each take about 25 minutes to complete.
Participants will be asked to provide a saliva sample using the saliva kit that will be mailed to them. Detailed instructions for collection will be included in the saliva collection packet.
Participants will be asked for permission to obtain a sample of their tumor tissue. Participants will receive a medical release form. Once they complete it and mail it back, investigators will request a small amount of tissue collected during the participant's prostate biopsy (or during their surgery, if they had surgery) from their health care provider.
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.
Time frame: Up to 3 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 years
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
H. Lee Moffitt Cancer Center and Research Institute