Validation of Decipher Test in African American Men With Prostate Cancer - VANDAAM

2016-03-31 09:53:21 | BioPortfolio


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 as well as death from prostate cancer. The use of the Decipher® score to predict how well a patient will do before treatment may make it possible for doctors to predict aggressive from mild prostate cancer and modify treatment accordingly. Thus, patients that do not need additional therapies will be spared from unnecessary side effects and those that are at risk will be provided with more aggressive therapy to improve survival.


This is a prospective validation study. Biopsy and prostatectomy specimens will be collected for genomic classifier (GC) testing. There will be no treatment intervention. Treatments will be conducted as per standard institutional guidelines since this is not an interventional study. Radical prostatectomy (RP) will be either by an open or laparoscopy radical prostatectomy procedure as per institutional procedure. For definitive radiation therapy (RT), treating physicians recommend patients be treated with 3D conformal radiotherapy, intensity-modulated radiotherapy, or Proton therapy following dose constraints to rectum and bladder as per institutional and/or Radiation Therapy Oncology Group (RTOG) guidelines. The institutional study Co-Principal Investigators will oversee RT quality assurance reviews for patients treated in those respective fashions. Peripheral blood samples will be collected for future biomarker studies.

There will be no treatment intervention or randomization in this study, therefore patients will be allowed to choose their definitive treatment option. Additionally, the informed consent for blood draw will be optional and patients who refuse blood draw will still be eligible for enrolment on the study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Prostate Cancer


Genomic Classifier (GC) Test


H. Lee Moffitt Cancer Center and Research Institute
United States


Not yet recruiting


H. Lee Moffitt Cancer Center and Research Institute

Results (where available)

View Results


Published on BioPortfolio: 2016-03-31T09:53:21-0400

Clinical Trials [2634 Associated Clinical Trials listed on BioPortfolio]

PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores

This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-Africa...

Genomics in Michigan Impacting Observation or Radiation

To determine the impact of Decipher test results on adjuvant treatment decisions of high-risk post-RP patients with undetectable post-op prostate specific antigen (PSA) compared to clinica...

Registry to Measure the Impact of Adding Genomic Testing

This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage local...

Engaging Newly Diagnosed Men About Cancer Treatment Options

This research is being done to better understand how a new lab test called the Oncotype DX Prostate Cancer Assay may impact what treatment men decide to get and how they feel and think abo...

A Real World Study In Urology Practices Looking At The Impact Of The OncotypeDX GPS Test On Men Choosing And Remaining On Active Surveillance

Genomic Health's OncotypeDX® Prostate Cancer Assay is a commercially available laboratory test that measures the activity of certain genes in prostate cancer. The purpose of this study is...

PubMed Articles [20635 Associated PubMed Articles listed on BioPortfolio]

Genomic classifier for guiding treatment of intermediate-risk prostate cancers to dose-escalated image-guided radiotherapy without hormone therapy.

The NCCN has recently endorsed the stratification of intermediate-risk prostate cancer (IR-PCa) into favorable and unfavourable subgourps, and recommend the addition of androgen deprivation therapy (A...

Optimizing patient's selection for prostate biopsy: A single institution experience with multi-parametric MRI and the 4Kscore test for the detection of aggressive prostate cancer.

To evaluate the performance of mpMRI and the 4Kscore test together for the detection of significant prostate cancer. Material and methods We selected a consecutive series of men who were referred for ...

Genomic Prostate Score, PI-RADSv2, and Progression in Men with Prostate Cancer on Active Surveillance.

OncotypeDx Genomic Prostate Score (GPS) is a 17-gene RNA expression assay intended to help guide treatment decisions for men diagnosed with prostate cancer. The Prostate Imaging-Reporting and Data Sys...

Improved prostate cancer diagnostics with a struc-tured pathway including the Stockholm3 test and MRI--targeted biopsies - experiences from Capio S:t Göran Prostate Cancer Center.

Capio S:t Göran Prostate Cancer Center is located in Stockholm and offers testing for prostate cancer using a structured pathway including the blood-test Stockholm3 and MRI-targeted prostate biopsies...

Association Analysis of a Microsatellite Repeat in the Gene With Prostate Cancer Risk, Aggressiveness and Survival.

With an estimated 1.1 million men worldwide diagnosed with prostate cancer yearly, effective and more specific biomarkers for early diagnosis could lead to better patient outcome. As such, novel genet...

Medical and Biotech [MESH] Definitions

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.

Tumors or cancer of the PROSTATE.

More From BioPortfolio on "Validation of Decipher Test in African American Men With Prostate Cancer - VANDAAM"

Quick Search


Searches Linking to this Trial