- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02997709
Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients (COMBINE)
Collection and Measurement of Blood and Imaging Biomarkers in Patients Undergoing Standard Primary and Postoperative Radiotherapy for Prostatic Neoplasms - The Miami CoMBINe Trial
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Pavel Noa Hechevarria
- Phone Number: 305-243-1036
- Email: pavel.noa@med.miami.edu
Study Locations
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Florida
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Miami, Florida, United States, 33136
- Recruiting
- University of Miami
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Contact:
- Pavel Noa Hechevarria
- Phone Number: 305-243-1036
- Email: pavel.noa@med.miami.edu
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Principal Investigator:
- Alan Pollack, MD, Ph.D.
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Principal Investigator:
- Matthew Abramowitz, MD
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Principal Investigator:
- Radka Stoyanova, Ph.D.
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Principal Investigator:
- Alan Dal Pra, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Radiation Therapy Group
Participants with prostate cancer diagnosis who are scheduled to undergo standard of care radiotherapy with or without the addition of Androgen Deprivation Therapy (ADT) will be evaluated
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Prostatectomy Group
Participants with prostate cancer diagnosis who are scheduled to undergo prostatectomy will be evaluated
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
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Baseline, within 8 Days Prior to End of RT, 3 months Post-RT, 9 months and 2-2.5 Years Post-RT
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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CTC changes between baseline and 2-2.5 years will be compared with 2-2.5 year biopsy positivity status (positive vs. negative) for patients whose baseline and 2-2.5 year biopsy samples are available.
CTC changes from two different time points will be tested for significance using t-test by 2-2.5 year biopsy positivity status.
Correlation structures between CTC and imaging parameters will be analyzed using linear mixed-effect model by 2-2.5 year biopsy positivity status.
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Between Baseline and 2-2.5 Years Post-RT
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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
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Change of CTC and imaging parameters at a specific time point from baseline will be compared by ADT status (yes vs. no) using t-test.
Correlation structure between CTC and imaging parameters will be analyzed using linear mixed-effect model by ADT status.
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Between Baseline and 2-2.5 Years Post-RT
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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
|
Gene expression data obtained at baseline will be analyzed in order to investigate the relationship between the gene expression and the following: CTCs, mpMRI imaging parameters, histopathological tumor parameters, and biochemical/clinical failure. CTC changes between baseline and 2-2.5 years will be compared with 2-2.5 year biopsy positivity status (positive vs. negative) for patients whose baseline and 2-2.5 year biopsy samples are available. CTC changes from two different time points will be tested for significance using t-test by 2-2.5 year biopsy positivity status. Changes in gene expression and imaging parameters will be analyzed in the same manner. Correlation structures between CTC and imaging parameters; CTC and gene expression; and imaging parameters and gene expression will be analyzed using linear mixed-effect model by 2-2.5 year biopsy positivity status. |
Between Baseline and 2-2.5 Years Post-RT
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Comparison of changes in CTCs to endpoint prostate research biopsy status.
Time Frame: Between Baseline and 2-2.5 Years Post-RT
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In patients who have undergone the MRI-US fusion guided biopsy (MUFgBx) at 2-2.5 years after all planned treatment, to investigate the relationship of circulating tumor cell (CTC) changes with the endpoint of research prostate biopsy status (only for those who are treated primarily with RT, who are not on indefinite ADT and who agree to this prostate early "endpoint" biopsy).
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Between Baseline and 2-2.5 Years Post-RT
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Comparison of changes in quantitative imaging characteristics to endpoint prostate research biopsy status.
Time Frame: Between Baseline and 2-2.5 Years Post-RT
|
In patients who have undergone the MRI-US fusion guided biopsy (MUFgBx) at 2-2.5 years after all planned treatment, to investigate the relationship of quantitative imaging characteristics with the endpoint of research prostate biopsy status (only for those who are treated primarily with RT, who are not on indefinite ADT and who agree to this prostate early "endpoint" biopsy).
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Between Baseline and 2-2.5 Years Post-RT
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Comparison of changes in gene expression patterns to endpoint prostate research biopsy status.
Time Frame: Between Baseline and 2-2.5 Years Post-RT
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In patients who have undergone the MRI-US fusion guided biopsy (MUFgBx) at 2-2.5 years after all planned treatment, to investigate the relationship of pretreatment biopsy tissue gene expression patterns with the research endpoint of prostate biopsy status (only for those who are treated primarily with RT, who are not on indefinite ADT and who agree to this prostate early "endpoint" biopsy).
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Between Baseline and 2-2.5 Years Post-RT
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Determination of the added value of PET/CT using newer tracers to MRI
Time Frame: Between Baseline and 2-2.5 Years Post-RT
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PET/CT using newer tracers (fluciclovine, prostate-specific membrane antigen (PSMA), or Choline) to MRI may add value in the above secondary analyses.
The investigators hypothesize that targeted PET agents will enhance the rate of accuracy of mpMRI in establishing high risk areas in the prostate, prostate bed, and pelvic lymph nodes, as well as provide unique information on early metastatic disease.
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Between Baseline and 2-2.5 Years Post-RT
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alan Pollack, MD, PhD, University of Miami
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20150452
- NCI-2019-08552 (Registry Identifier: NCI Clinical Trials Reporting Program (NCI CTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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