Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

Clinicaltrials.gov ID: NCT02997709
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 30 Years
b-bullseye-arrow Enrollments 144

Conditions

Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Alan Pollack, MD, PhD

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.

Study Plan

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

Prostatectomy Group

Participants with prostate cancer diagnosis who are scheduled to undergo prostatectomy will be evaluated

Outcome Measures

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

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

Timeline

  • Last Updated
    January 31, 2024
  • Start Date
    December 20, 2016
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    June 1, 2031

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