Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT02997709
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jun 24, 2016
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2032

Study Design

Enrollment
144 participants (estimated)

Arms

  • Arm: 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
  • Arm: Prostatectomy Group
    Participants with prostate cancer diagnosis who are scheduled to undergo prostatectomy will be evaluated.

Primary Outcome Measure

Comparison of Pre- and Post-Treatment Quantitative Imaging Parameters to Changes in Circulating Tumor Cells Over Time in Study Participants. [ Time Frame: Baseline, within 8 Days Prior to End of RT, 3 months Post-RT, 9 months and 2-2.5 Years Post-RT ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Pavel Noa Hechevarria
[email protected]
305-243-1036
Alan Pollack, MD, Ph.D. (PRINCIPAL_INVESTIGATOR)
Matthew Abramowitz, MD (PRINCIPAL_INVESTIGATOR)
Radka Stoyanova, Ph.D. (PRINCIPAL_INVESTIGATOR)
Alan Dal Pra, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Miami· Miami, FL

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