Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

University of Miami144 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

144

Conditions

Prostate Cancer

Eligibility

Sex: MALEMin age: 30 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

Relationship of CTC changes and/or quantitative imaging parameter changes to patient outcome (biochemical and clinical disease 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. Correlation structures between CTC and imaging parameters will be analyzed using linear mixed-effect model by 2-2.5 year biopsy positivity status.