An observational study in Prostate Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Active, not recruiting at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Observational
The primary purpose of this study is to determine whether a tumor test recently developed by GenomeDx Biosciences known as Decipher® can predict aggressive prostate cancer with the same accuracy in African-American men (AAM) as in non-African-American men (NAAM). The Decipher® test was developed from samples derived mainly from men of European origins and little is known about its performance in AAM. It is important to study 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. Thus, patients that do not need additional therapies may be spared from unnecessary side effects and those that are at risk may be provided with more aggressive therapy to improve survival. This study is being done to learn whether the Decipher test can really affect these outcomes.
This is a multisite, prospective validation trial. Based on a population consisting of 25% AAM and 75% NAAM, investigators will actively recruit participants and aim to achieve a 1:1 enrollment ratio of AAM to NAAM. To achieve this, low risk AAM will be accrued first and then matching NAAM will be enrolled. NAAM men will be matched to AAM on prostate specific antigen (PSA) at diagnosis.
There will be no treatment intervention beyond standard of care (SOC), and therefore participants will be allowed to choose their definitive treatment option. The intent is to enroll low risk and high volume disease (burden) patients to limit the accrual of patients that would select active surveillance (AS).
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 240 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men diagnosed with localized prostate cancer.
Exclusion Criteria:
AAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment.
Other: Decipher® Testing
NAAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment.
Other: Decipher® Testing
Decipher® Prostate Cancer Classifier (Post-Op and Biopsy), a Genomic Classifier (GC) test. Biopsy and prostatectomy specimens will be collected for GC testing.
Also known as: Genomic Classifier (GC) test
Two Year Prostatic Specific Antigen (PSA) Failure Rate
PSA failure defined for first line treatment options of Radical Prostatectomy (RP) and Radiotherapy (RT) in accordance with National Comprehensive Cancer Network (NCCN) guidelines: PSA failure for RP is defined by an undetectable PSA after surgery with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence); or failure of PSA to fall to undetectable levels (PSA persistence). PSA failure for treatment with RT is defined as PSA increase by 2 ng/mL or more above the nadir PSA. To estimate the performance of genomic classifier (GC) in predicting 2-yr PSA failure rate, the area under curve (AUC) of a standard Receiver Operating Characteristic (ROC) curve will be calculated with corresponding 95% confidence intervals using resampling methods. In addition, positive and negative predictive probabilities, sensitivity, specificity and accuracy and associated 95% confidence intervals will also be calculated using predefined cut-points of 0.45 and 0.60.
Time frame: Up to 24 months
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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H. Lee Moffitt Cancer Center and Research Institute