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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Prostate005 Trial 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.Check my eligibility
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.See study design
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.
Prostate005 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is classified as high risk.
Select...
I am a man aged 18 or older.
Select...
I am fully active or can carry out light work.
Prostate005 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare GU toxicity rate to the rate published in the ASCENDE-RT trial
Secondary outcome measures
Describe impact of treatment on quality of life
Estimate GI and sexual toxicity
Estimate freedom from biochemical failure (RFS)
+2 moreProstate005 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
754 Previous Clinical Trials
1,245,013 Total Patients Enrolled
1 Trials studying Prostate Cancer
410 Patients Enrolled for Prostate Cancer
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
1 Trials studying Prostate Cancer
32 Patients Enrolled for Prostate Cancer
Chris Luminais, MDPrincipal InvestigatorUniversity of Virginia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with prostate cancer within the last year.I do not have severe liver problems or jaundice.I am currently on IV antibiotics for a bacterial or fungal infection.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.My prostate cancer is classified as high risk.I have severe health conditions besides my cancer.I have had radiation to my pelvis, seed implants in my prostate, or both testicles removed.I had a severe heart attack within the last 6 months.I am willing and able to follow all study rules and attend all appointments.I am eligible for specific prostate cancer treatments including internal radiation, external beam radiation, and possibly hormone therapy.I am a man aged 18 or older.I am fully active or can carry out light work.I have had surgery or cryosurgery for prostate cancer.My PSA level was below 50 ng/mL before hormone therapy or in the last year.I have had radiation treatment in the same area as my current cancer.I have received chemotherapy for prostate cancer before.I do not have a severe lung condition that requires hospital care right now.My cancer has spread to my bones.I have been cancer-free for over 3 years, except for non-melanoma skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being recruited for this research endeavor?
"Affirmative, the information hosted on clinicaltrials.gov demonstrates that this scientific experiment is recruiting participants. Inception of the trial was July 30th 2020 and it has been recently updated October 23rd 2020. This initiative requires 60 research subjects to be enlisted from a single facility."
Answered by AI
Has this therapy been granted the regulatory stamp of approval from the Federal Drug Administration?
"With only Phase 2 trial data available, Power assigned this potential treatment a score of 2 for its safety profile. This indicates that there is some evidence to support the toxicity and side effects but none yet indicating efficacy."
Answered by AI
Is enrollment for this trial still open?
"Affirmative. Data available on clinicaltrials.gov supports the notion that this medical trial is still searching for participants, with 60 patients sought from a single site since its initial posting on July 30th 2020 and most recent update occurring October 23rd of last year."
Answered by AI
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