Clinical trial NCT02997709: Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Circulating Tumor Cells
CTCs
Androgen Deprivation Therapy
ADT
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Bankhead-Coley Florida Biomedical Research Program
First posted: 2016-12-20
Enrollment: 144
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult men with a prostate cancer diagnosis undergoing standard of care treatment at the University of Miami.

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Pathologic confirmation of prostate cancer.
2. Any T-stage.
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 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).
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. The ability to understand and the willingness to sign a written informed consent document
9. Zubrod performance status ≤ 2 (Karnofsky or ECOG performance status may be used to estimate Zubrod):
10. Age ≥ 30 at signing of consent.
11. Subjects must be planned to receive radiation therapy or to undergo prostatectomy.
12. Subjects treated primarily with RT are recommended to have had an MUFgBx prior to radiation treatment.

Primary outcomes:
measure: Comparison of Pre- and Post-Treatment Quantitative Imaging Parameters to Changes in Circulating Tumor Cells Over Time in Study Participants.
timeFrame: Baseline, within 8 Days Prior to End of RT, 3 months Post-RT, 9 months and 2-2.5 Years Post-RT
Secondary outcomes:
measure: Relationship of CTC changes and/or quantitative imaging parameter changes to patient outcome (biochemical and clinical disease failure).
timeFrame: Between Baseline and 2-2.5 Years Post-RT
measure: Relationship of Androgen Deprivation Therapy (ADT) status to quantitative imaging features and/or CTC levels in patients
timeFrame: Between Baseline and 2-2.5 Years Post-RT
measure: 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.
timeFrame: Between Baseline and 2-2.5 Years Post-RT
measure: Comparison of changes in CTCs to endpoint prostate research biopsy status.
timeFrame: Between Baseline and 2-2.5 Years Post-RT
measure: Comparison of changes in quantitative imaging characteristics to endpoint prostate research biopsy status.
timeFrame: Between Baseline and 2-2.5 Years Post-RT
measure: Comparison of changes in gene expression patterns to endpoint prostate research biopsy status.
timeFrame: Between Baseline and 2-2.5 Years Post-RT
measure: Determination of the added value of PET/CT using newer tracers to MRI
timeFrame: Between Baseline and 2-2.5 Years Post-RT
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Alan Pollack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: