Back to search results

Observational Study on Biomarkers in Prostate Cancer Radiotherapy

This observational study aims to understand how standard radiation treatment for prostate cancer affects changes seen in MRI and PET imaging. Researchers will compare these imaging changes with the number of circulating tumor cells (CTCs) in your blood before and after treatment. They will also look at how these imaging and CTC changes relate to gene expression in your cancer tissue. The goal is to learn how these factors predict your response to prostate cancer treatment. You may be eligible if you are a man aged 30 or older with pathologically confirmed prostate cancer, any T-stage, and N0/N1 and M0/M1 disease, including metastatic disease. This study is currently unclear on its recruitment status.

Study design
This is an observational study with a planned enrollment of 144 participants. It is not a treatment study but rather focuses on collecting and measuring information.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed at baseline, within 8 days prior to the end of radiation therapy (RT), 3 months post-RT, 9 months post-RT, and 2-2.5 years post-RT.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02997709

Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

Recruiting
Not specifiedAges 30+Observational
University of Miami
~144 participants
Updated 2026-03-04 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of Pre- and Post-Treatment Quantitative Imaging Parameters to Changes in Circulating Tumor Cells Over Time in Study Participants.
Measured over Baseline, within 8 Days Prior to End of RT, 3 months Post-RT, 9 months and 2-2.5 Years Post-RT

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Alan Pollack, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Pavel Noa Hechevarria
[email protected]
305-243-1036
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

What this trial measures

  • Comparison of Pre- and Post-Treatment Quantitative Imaging Parameters to Changes in Circulating Tumor Cells Over Time in Study Participants.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) 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.