EBRT + BTX + ADT, PET and MRI for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Wisconsin, Madison, WI
Prostate Cancer+1 More
External beam radiation therapy - Radiation
Eligibility
18+
All Sexes
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Study Summary

The purpose of this study is to evaluate the imaging and gene expression biomarkers in prostate cancer. Participants have high-risk prostate cancer and have indicated they will undergo external beam radiation therapy, brachytherapy, and androgen deprivation therapy (EBRT+BTX+ADT). Participants can expect to be in this study for up to 5 years.

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Baseline, 3 months post therapy, every 6 months for 5 years

Month 3
Changes in cancer gene expression during therapy
Establish a correlation between MRI imaging response and pathologic response
Establish a correlation between PET imaging response and pathologic response
Evaluate blood-based biomarkers for treatment response.
Genomic signatures correlated with imaging response
Prognostic significance of higher order radioman metrics
Year 5
Imaging and genomic markers for prostate specific antigen (PSA) recurrence.
Month 3
Imaging markers for mid-treatment response

Trial Safety

Trial Design

1 Treatment Group

EBRT + BTX + ADT, PET and MRI
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: EBRT + BTX + ADT, PET and MRI · No Placebo Group · Phase < 1

EBRT + BTX + ADT, PET and MRIExperimental Group · 4 Interventions: External beam radiation therapy, Prostate brachytherapy boost, Androgen deprivation therapy, Positron emission tomography (PET)/magnetic resonance imaging (MRI) · Intervention Types: Radiation, Radiation, Drug, DiagnosticTest
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External beam radiation therapy
2009
Completed Phase 3
~450
Androgen deprivation therapy
2015
Completed Phase 4
~240

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months post therapy, every 6 months for 5 years
Closest Location: University of Wisconsin · Madison, WI
Photo of wi university of wisconsin  1Photo of madison  2Photo of madison  3
2003First Recorded Clinical Trial
14 TrialsResearching Prostate Cancer
380 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.