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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.
Observational Model: Cohort, Time Perspective: Prospective
Genomic Classifier (GC) Test
H. Lee Moffitt Cancer Center and Research Institute
Not yet recruiting
H. Lee Moffitt Cancer Center and Research Institute
Published on BioPortfolio: 2016-03-31T09:53:21-0400
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...
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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.