Last updated on June 2019

Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients


Brief description of study

Prostate cancer is the most common malignancy in men and nearly 30,000 men die from the disease each year. Not only is there significant mortality, there is considerable morbidity from primary and salvage therapies. Understanding which patients require intensified treatment, as well as those who may not, would improve outcomes on multiple levels. The cohort to be investigated will be composed of men diagnosed with prostate cancer who are planned to be treated with (i) external beam radiotherapy to the prostate (primary treatment) (ii) prostatectomy (added in amendment) or (iii) postoperative radiotherapy (adjuvant or salvage treatment post-prostatectomy). Adjuvant postoperative radiotherapy is defined as men having a PSA<0.1 ng/mL and salvage postoperative radiotherapy as those having a PSA 0.1. The overarching objective of the CoMBINe trial is to identify pre-treatment and post-treatment prognostic and predictive factors derived from quantitative imaging prostate or prostate bed features, tumor tissue gene expression signatures, and circulating tumor cells (CTCs). The CoMBINe trial is a sister trial to another study, termed BLaStM (IRB# 20140627), in men who are candidates for primary radiotherapy. CoMBINe also allows for men with oligometastasis from prostate cancer who are treated to all sites of known disease by radiotherapy and/or surgery.

Detailed Study Description

Treatment: Prostatectomy, radiotherapy technique, radiotherapy dose, and the use of androgen deprivation therapy (ADT), are per the standard of care at the University of Miami, and are not specified in this protocol.

Measurements: Prior to treatment and at 3 months, 6 months, and at 2.0-2.5 years after treatment, the patients will have blood drawn for CTCs and additional blood stored for future studies. Multiparametric MRI (mpMRI) and potentially PET/CT (depending on funding) will be done at these same time points. Health related quality of life is also being assessed at these time points.

Overarching goal: To determine the relationships to quantitative imaging features (imaging biomarkers) to blood based biomarkers and tissue based gene expression marker/signatures, as well as to patient outcome.

Clinical Study Identifier: NCT02997709

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