Actively Recruiting

Age: 30Years +
MALE
NCT02997709

Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

Led by University of Miami · Updated on 2026-03-04

144

Participants Needed

1

Research Sites

835 weeks

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

B

Bankhead-Coley Florida Biomedical Research Program

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

Who Can Participate

Age: 30Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologic confirmation of prostate cancer
  • Any T-stage of prostate cancer
  • Patients with disease staging of N0/N1 and M0/M1 by imaging or clinical criteria
  • Patients with metastatic disease are encouraged to participate
  • Any Gleason Score is eligible
  • Androgen deprivation therapy (ADT) must be declared as none, short-term (≤7 months), long-term (>7 and ≤36 months), or extended (>36 months) prior to enrollment
  • Prostate-specific antigen (PSA) ≤100 ng/mL within 4 months of consent (if PSA was >100 and drops to <100 with antibiotics, enrollment is allowed)
  • No previous pelvic radiotherapy
  • Ability to understand and willingness to sign informed consent
  • Zubrod performance status ≤2 (Karnofsky or ECOG may be used to estimate)
  • Age 30 years or older at consent
  • Planned to receive radiation therapy or undergo prostatectomy
  • Subjects treated primarily with radiation therapy are recommended to have had an MUFgBx prior to radiation treatment
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

P

Pavel Noa Hechevarria

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients | DecenTrialz