Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

NCT02997709 | Recruiting DMC

• 2 other identifiers: 20150452NCI-2019-08552
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Circulating Tumor Cells; CTCs; Androgen Deprivation Therapy; ADT

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, within 8 Days Prior to End of RT, 3 months Post-RT, 9 months and 2-2.5 Years Post-RT

Secondary Outcomes (7)

• Relationship of CTC changes and/or quantitative imaging parameter changes to patient outcome (biochemical and clinical disease failure).

  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

  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.

  Between Baseline and 2-2.5 Years Post-RT

• Comparison of changes in CTCs to endpoint prostate research biopsy status.

  Between Baseline and 2-2.5 Years Post-RT

• Comparison of changes in quantitative imaging characteristics to endpoint prostate research biopsy status.

  Between Baseline and 2-2.5 Years Post-RT

Study Arms (2)

Radiation Therapy Group

Participants with prostate cancer diagnosis who are scheduled to undergo radiotherapy (definitive or palliative) 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.

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: Adult men with a prostate cancer diagnosis.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult men with a prostate cancer diagnosis undergoing standard of care treatment at the University of Miami.

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• Bankhead-Coley Florida Biomedical Research Program: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected pre-RT and in post-RT follow-up for research. Plasma and serum, as well as red cells and lymphocytes (buffy coat) will be collected. The procedures will evolve with new developments, such as the ability to isolate viable CTCs for cell culture and gene expression analyses. Excess blood that is not processed for CTC or biomarkers will be stored for future research. Genomic studies, including genome-wide association studies (GWAS), will examine associations with health conditions are planned. Gene expression from mpMRI-defined high risk tumor regions will be related to pathologic parameters and RT response. Using a 1.4M marker oligonucleotide microarray that is essentially a whole transcriptome assay, selected pathways will be examined in pre-Tx biopsies.

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alan Pollack, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavel Noa Hechevarria

CONTACT

305-243-1036; pavel.noa@med.miami.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 20, 2016
• Study Start: June 24, 2016
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2032
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)