Collection and Measurement of Blood and Imaging Biomarkers in Patients Undergoing Standard Primary and Postoperative Radiotherapy for Prostatic Neoplasms - The Miami CoMBINe Trial
Summary
The purpose of this research study is to learn about: 1) How standard radiation treatment to prostate (primary radiotherapy) or the pelvis after prostatectomy (postoperative radiotherapy) may cause changes in MRI and PET imaging traits that might be used in the future to predict response. 2) Comparison of such MRI and PET imaging traits with the number of circulating tumor cells (CTCs) present in the blood prior to treatment and the changes in these counts after treatment. 3) How MRI and PET imaging characteristics and changes are related to the expression of genes in the cancer tissue obtained before treatment from prostate biopsy or a prior prostatectomy before treatment. 4) How the response of prostate cancer treatment relates to the imaging and CTC changes.
Arms & interventions
Outcome measures
Primary
Comparison of Pre- and Post-Treatment Quantitative Imaging Parameters to Changes in Circulating Tumor Cells Over Time in Study Participants.
Pre-Treatment and Post-Treatment quantitative imaging parameters will be associated with circulating tumor cell (CTC) changes over time in prostate cancer (PCa) patients who receive treatment with RT ± androgen deprivation therapy (ADT) or prostatectomy per standard of care. CTC and quantitative imaging changes will be determined at each of the planned research acquisition time points (8 days prior to completion of radiation therapy (RT), 3 months post-RT, 9 months post-RT, and 2-2.5 years post-treatment) comparing to the Baseline.
Time frame: Baseline, within 8 Days Prior to End of RT, 3 months Post-RT, 9 months and 2-2.5 Years Post-RT
Secondary
Relationship of CTC changes and/or quantitative imaging parameter changes to patient outcome (biochemical and clinical disease failure).
Time frame: Between Baseline and 2-2.5 Years Post-RT
Relationship of Androgen Deprivation Therapy (ADT) status to quantitative imaging features and/or CTC levels in patients
Time frame: Between Baseline and 2-2.5 Years Post-RT
Relationship of quantitative imaging characteristics and/or CTC changes with other tissue biomarkers obtained from the pre-treatment MRI ultrasound (US) fusion guided prostate biopsy or prostatectomy tissue in those treated primarily.
Time frame: Between Baseline and 2-2.5 Years Post-RT
Comparison of changes in CTCs to endpoint prostate research biopsy status.
Time frame: Between Baseline and 2-2.5 Years Post-RT
Comparison of changes in quantitative imaging characteristics to endpoint prostate research biopsy status.
Time frame: Between Baseline and 2-2.5 Years Post-RT
Comparison of changes in gene expression patterns to endpoint prostate research biopsy status.
Time frame: Between Baseline and 2-2.5 Years Post-RT
Determination of the added value of PET/CT using newer tracers to MRI
Time frame: Between Baseline and 2-2.5 Years Post-RT
Eligibility criteria
Study locations (1)
University of Miami
Miami, Florida, 33136