We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 69 for:    prostate cancer | Recruiting Studies | United States, Florida
Previous Study | Return to List | Next Study

Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients (COMBINE)

This study is currently recruiting participants.
Verified October 2017 by Alan Pollack, University of Miami
Sponsor:
ClinicalTrials.gov Identifier:
NCT02997709
First Posted: December 20, 2016
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alan Pollack, University of Miami
  Purpose
Prostate cancer is the most common malignancy in men and nearly 30,000 deaths occur from the disease each year. Not only is there significant mortality, there is also considerable morbidity from primary and salvage therapies. Understanding which patients require intensified treatment, as well as those who might not require treatment, would improve outcomes on multiple levels. The cohort to be investigated will be comprised of men with intermediate to high risk prostate cancer who are candidates for radiotherapy (RT). The overarching objective of the CoMBINe trial is to identify pretreatment and post-treatment prognostic and predictive factors derived from quantitative imaging prostate 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 radiotherapy. CoMBINe also allows for men with oligometastasis who are sometimes treated with RT to the prostate and limited metastatic sites.

Condition Intervention
Prostate Cancer Procedure: Blood Specimen Collection Behavioral: Memorial Anxiety Scale for Prostate Cancer patients Behavioral: Expanded Prostate Cancer Index Composite-SF-12 Behavioral: International Prostate Symptom Score Device: MRI-US fusion guided biopsy Device: Multiparametric MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Alan Pollack, University of Miami:

Primary Outcome Measures:
  • Comparison of Pre- and Post-Treatment Quantitative Imaging Parameters to Changes in Circulating Tumor Cells Over Time in Prostate Cancer Patients Receiving Radiation Therapy (RT) with or without Androgen Deprivation Therapy per standard of care. [ 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) 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.


Secondary Outcome Measures:
  • 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 ]
    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.

  • Relationship of Androgen Deprivation Therapy (ADT) status to quantitative imaging features and/or CTC levels in patients receiving radiation therapy. [ Time Frame: Between Baseline and 2-2.5 Years Post-RT ]
    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.

  • Relationship of quantitative imaging characteristics and/or CTC changes with other tissue biomarkers (e.g., gene expression signatures) obtained from the pre-treatment MRI ultrasound (US) fusion guided prostate. [ 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.


  • Comparison of changes in CTCs 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 ofcirculating tumor cell (CTC) changes with the endpoint of research prostate biopsy status.

  • 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.

  • Comparison of changes in gene expression patterns 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 pretreatment biopsy tissue gene expression patterns with the research endpoint of prostate biopsy status.


Estimated Enrollment: 300
Actual Study Start Date: June 24, 2016
Estimated Study Completion Date: June 2026
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COMBINE Patients
  • Blood specimen collection
  • Expanded Prostate Cancer Index Composite-SF-12
  • Memorial Anxiety Scale for Prostate Cancer patients
  • International Prostate Symptom Score
  • Multiparametric MRI (mpMRI) of the prostate
  • MRI-US fusion guided biopsy
Procedure: Blood Specimen Collection
Blood specimen collection (plasma and serum) for CTCs and other possible biomarkers pre-radiation therapy at Baseline, during treatment and at various intervals post-treatment, per study protocol.
Behavioral: Memorial Anxiety Scale for Prostate Cancer patients
Memorial Anxiety Scale for Prostate Cancer (MAX-PC) patients administered to study participants at Baseline and at intervals during treatment and post-follow-up, per study protocol.
Other Name: MAX-PC
Behavioral: Expanded Prostate Cancer Index Composite-SF-12
Expanded Prostate Cancer Index Composite (EPIC) Short Form 12 (SF-12) administered to study participants at Baseline and at intervals during treatment and post-follow-up, per study protocol.
Other Name: EPIC-SF-12
Behavioral: International Prostate Symptom Score
International Prostate Symptom Score (IPSS) administered to study participants at Baseline and at intervals during treatment and post-follow-up, per study protocol.
Other Name: IPSS
Device: MRI-US fusion guided biopsy
MRI-US fusion guided biopsy (MUFgBx) of prostate for research at baseline and 2-2.5 years post-treatment.
Other Name: MUFgBx
Device: Multiparametric MRI
Multiparametric MRI at Baseline and various time points post-treatment per study protocol.
Other Name: mpMRI

Detailed Description:

Primary objective -To investigate the relationship of quantitative imaging parameters (multiparametric MRI) pretreatment (pre-Tx) and post-treatment to changes in circulating tumor cells (CTCs) over time in prostate cancer patients who receive treatment with radiotherapy ± androgen deprivation therapy (ADT) per standard of care at the Department of Radiation Oncology at the University of Miami.

Secondary objectives

  • To evaluate whether CTC changes and/or quantitative imaging parameter changes are associated with patient outcome (biochemical and clinical disease failure).
  • To evaluate whether ADT will affect quantitative imaging features and/or CTC levels in patients receiving therapy.
  • To investigate the relationship of quantitative imaging characteristics and/or circulating tumor cell (CTC) changes with other tissue biomarkers (e.g., gene expression signatures) obtained from the pre-treatment MRI ultrasound (US) fusion guided prostate biopsy.
  • 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, circulating tumor cell (CTC) changes, and/or pretreatment biopsy tissue gene expression patterns with the endpoint prostate research biopsy status.

Treatment

-Radiotherapy technique and dose, as well as 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biopsy confirmed primary tumor of the prostate
  2. Any clinical T-stage based on digital rectal exam
  3. By imaging or clinical criteria, any patient with disease staging of N0/N1 and M0/M1

    • Patients with metastatic disease are encouraged to participate.
  4. Any Gleason score will be eligible
  5. Androgen deprivation therapy (ADT) is at the discretion of the treating physician; but must be decided (none, short-term or long-term as counted from the luteinizing hormone-releasing hormone (LHRH) agonist injection) prior to the start of radiotherapy. However if it is planned, the following restrictions apply:

    • It must be started prior to the start of radiotherapy and
    • The total length planned must be ≤ 36 months
    • Short term ADT is defined as ≤ 7 months
    • Long term ADT is defined as > 7 months and ≤ 36 months
    • Permanent ADT is defined as >36 months (e.g., M1 patients)
  6. 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.
  7. No previous pelvic radiotherapy
  8. Ability to understand and the willingness to sign a written informed consent document
  9. Zubrod performance status ≤ 2 (Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod)
  10. Age ≥35 and ≤85 years at signing of consent
  11. Subjects must be planned to receive radiation therapy
  12. Subjects must be planned for an MRI-US fusion guided biopsy (MUFgBx) prior to radiation treatment

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997709


Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Alan Pollack, MD, Ph.D.    305-243-4916    APollack@med.miami.edu   
Principal Investigator: Alan Pollack, MD, Ph.D.         
Sub-Investigator: Matthew Abramowitz, MD         
Sub-Investigator: Adrian Ishkanian, MD         
Sub-Investigator: Radka Stoyanova, Ph.D.         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Alan Pollack, MD, Ph.D. University of Miami
  More Information

Responsible Party: Alan Pollack, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02997709     History of Changes
Other Study ID Numbers: 20150452
First Submitted: December 15, 2016
First Posted: December 20, 2016
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We have not developed a plan yet for IPD data sharing; although, our protocol and consent indicate plans to do so in the future after publication.

Keywords provided by Alan Pollack, University of Miami:
Prostate Cancer
Circulating Tumor Cells
CTCs
Androgen Deprivation Therapy
ADT

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases