Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 30 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Collection and Measurement of Blood and Imaging Biomarkers in Patients Undergoing Standard Primary and Postoperative Radiotherapy for Prostatic Neoplasms - The Miami CoMBINe Trial
Overview
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.
Primary outcome measures
- Comparison of Pre- and Post-Treatment Quantitative Imaging Parameters to Changes in Circulating Tumor Cells Over Time in Study Participants. [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 outcome measures (7)
- 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
Inclusion criteria
- Pathologic confirmation of prostate cancer.
- Any T-stage.
- By imaging or clinical criteria, any patient with disease staging of N0/N1 and M0/M1.
- Patients with metastatic disease are encouraged to participate.
- Any Gleason Score will be eligible.
- Androgen deprivation therapy (ADT) is at the discretion of the treating physician, but must be declared as none, short-term, long-term, or extended prior to enrollment. The length is calculated from the LHRH (agonist injection). If ADT is planned (based on treating physician preference), the following restrictions apply:
- Short term ADT is defined as ≤ 7 months;
- Long term ADT is defined as > 7 months and ≤ 36 months;
- Extended ADT is defined as >36 months (e.g., M1 patients).
- Prostate-specific antigen (PSA) ≤100 ng/mL within (+/-) 4 months of signing of consent. If PSA was above 100 and drops to <100 with antibiotics, this is acceptable for enrollment.
- No previous pelvic radiotherapy.
- The ability to understand and the willingness to sign a written informed consent document
- Zubrod performance status ≤ 2 (Karnofsky or ECOG performance status may be used to estimate Zubrod):
- Age ≥ 30 at signing of consent.
- Subjects must be planned to receive radiation therapy or to undergo prostatectomy.
- Subjects treated primarily with RT are recommended to have had an MUFgBx prior to radiation treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT02997709 · 20150452 · NCI-2019-08552