144 Participants Needed

Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

(COMBINE Trial)

PN
Overseen ByPavel Noa Hechevarria
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

AP

Alan Pollack, MD, PhD

Principal Investigator

University of Miami

Eligibility Criteria

Inclusion Criteria

Pathologic confirmation of prostate cancer.
Any T-stage.
By imaging or clinical criteria, any patient with disease staging of N0/N1 and M0/M1.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive standard radiation treatment to the prostate or pelvis after prostatectomy

8 weeks
Regular visits for radiation sessions

Post-Treatment Monitoring

Quantitative imaging parameters and circulating tumor cell (CTC) changes are monitored

3 months
1 visit (in-person) at 3 months post-RT

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-2.5 years
Periodic visits for imaging and biopsy assessments

Treatment Details

Interventions

  • Postoperative Radiotherapy
  • Primary Radiotherapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Bankhead-Coley Florida Biomedical Research Program

Collaborator

Trials
3
Recruited
280+
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