Actively Recruiting
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
Eligibility Criteria
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
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
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
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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