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Hormone Therapy

EBRT + ADT + HDR Brachytherapy for Prostate Cancer (Prostate005 Trial)

Phase 2
Recruiting
Led By Timothy Showalter, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unfavorable-intermediate risk, high risk, or very high-risk prostate cancer as determined by the NCCN Guidelines Version 4.2019 (Section 12.4).
Male, aged 18 or above.
Must not have
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation effects or severe liver dysfunction.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of ADT, HDR brachytherapy, and EBRT to see if it causes fewer side effects and improves patient outcomes.

Who is the study for?
This trial is for men over 18 with a specific diagnosis of prostate cancer that's considered unfavorable-intermediate, high, or very high-risk. They should have an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but can do light work. Participants must not have had certain previous treatments like pelvic irradiation and should not be suffering from severe health conditions such as unstable heart disease.
What is being tested?
The study tests if combining Androgen deprivation therapy (ADT), MRI-guided HDR brachytherapy (internal radiation), and external beam radiation therapy (EBRT) reduces side effects while improving patient outcomes and survival rates. It examines the quality of life after receiving these combined treatments for prostate cancer.
What are the potential side effects?
Potential side effects may include urinary issues, bowel problems, erectile dysfunction, fatigue, skin irritation near treatment areas, hot flashes from ADT, and possibly other symptoms related to hormone changes or radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is classified as high risk.
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I am a man aged 18 or older.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe liver problems or jaundice.
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I am currently on IV antibiotics for a bacterial or fungal infection.
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I have had radiation to my pelvis, seed implants in my prostate, or both testicles removed.
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I have had surgery or cryosurgery for prostate cancer.
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I have had radiation treatment in the same area as my current cancer.
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I do not have a severe lung condition that requires hospital care right now.
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My cancer has spread to my bones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compare GU toxicity rate to the rate published in the ASCENDE-RT trial
Secondary study objectives
Describe impact of treatment on quality of life
Estimate GI and sexual toxicity
Estimate freedom from biochemical failure (RFS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation
2014
Completed Phase 2
~70
Androgen Deprivation Therapy
2008
Completed Phase 2
~110
HDR Brachytherapy
2014
N/A
~100

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,665 Total Patients Enrolled
Timothy Showalter, MDPrincipal Investigator - University of Virginia
University of Virginia Medical Center
University Of Virginia School Of Medicine (Medical School)
Thos Jefferson University Hospital (Residency)
2 Previous Clinical Trials
290 Total Patients Enrolled
Chris Luminais, MDPrincipal InvestigatorUniversity of Virginia

Media Library

Androgen Deprivation Therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04465500 — Phase 2
Prostate Adenocarcinoma Research Study Groups: Treatment
Prostate Adenocarcinoma Clinical Trial 2023: Androgen Deprivation Therapy Highlights & Side Effects. Trial Name: NCT04465500 — Phase 2
Androgen Deprivation Therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04465500 — Phase 2
~19 spots leftby Jan 2027
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