← Back to Search

Hormone Therapy

Hormone Therapy + Radiation for Prostate Cancer

Phase 3
Recruiting
Led By Neil B Desai
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with chronic HBV infection must have undetectable viral load on suppressive therapy
Unfavorable intermediate risk prostate cancer meeting specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until t > 200 ng/dl, assessed up to 11 years
Awards & highlights

Study Summary

This trial is testing whether using the Decipher risk score to guide treatment results in better control of the cancer and prevents it from spreading, with fewer side effects.

Who is the study for?
Men aged 18+ with unfavorable intermediate risk prostate cancer, specifically adenocarcinoma of the prostate, without prior treatments like radiotherapy or hormonal therapy to the pelvis. They must have a certain level of physical fitness (ECOG 0-2), adequate organ function, and no severe co-morbidities or high-risk features such as Gleason score 8-10 or metastatic disease.Check my eligibility
What is being tested?
The trial is testing two approaches based on Decipher gene risk scores: less intense treatment (radiation alone) for low-risk patients versus more intense treatment (radiation plus hormone therapy and darolutamide) for higher-risk patients. Darolutamide blocks male hormones that can fuel cancer growth.See study design
What are the potential side effects?
Possible side effects include fatigue, hot flashes from hormone therapy, bowel and urinary issues from radiation, and potential liver changes due to darolutamide. The intensity of side effects may vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have chronic hepatitis B but it's under control with medication.
Select...
My prostate cancer is at an intermediate stage but considered high risk.
Select...
My white blood cell count is healthy.
Select...
I am 18 years old or older.
Select...
My kidney function, measured by creatinine clearance, is adequate.
Select...
I had hepatitis C but have been successfully treated and cured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until t > 200 ng/dl, assessed up to 11 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until t > 200 ng/dl, assessed up to 11 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Distant Metastasis (DM) (De-intensification study)
Metastasis-Free Survival (MFS) (Intensification study)
Secondary outcome measures
Cognition
Distant Metastasis (DM) including PET imaging
Distant Metastasis (Intensification study)
+9 more
Other outcome measures
Bowel and urinary function related quality of life
Cardio-metabolic markers
Castrate-resistant prostate cancer (CRPC)
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm IV (RT, ADT, darolutamide)Experimental Treatment9 Interventions
Patients receive RT and ADT as in Arm II. Patients also receive darolutamide PO BID on days 1-90. Treatment repeats every 90 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm III (RT, ADT)Experimental Treatment10 Interventions
Patients receive treatment as in Arm II.
Group III: Arm II (RT, ADT)Experimental Treatment10 Interventions
Patients undergo RT as Arm I. Patients also receive ADT consisting of leuprolide, goserelin, buserelin, histrelin, triptorelin, degarelix, or relugolix at the discretion of the treating physician, for 6 months in the absence of disease progression or unacceptable toxicity. Patients may also receive bicalutamide or flutamide for 0, 30 or 180 days.
Group IV: Arm I (RT)Experimental Treatment1 Intervention
Patients undergo RT using a recognized regimen (2-3 days a week or 5 days a week for 2-11 weeks) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relugolix
2016
Completed Phase 3
~5360
Degarelix
2002
Completed Phase 3
~3600
Leuprolide
2008
Completed Phase 4
~18970
Bicalutamide
2003
Completed Phase 3
~5330
Triptorelin
2017
Completed Phase 4
~1370
Darolutamide
2018
Completed Phase 2
~100
Flutamide
2013
Completed Phase 4
~1920
Goserelin
2008
Completed Phase 3
~4110
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,922,471 Total Patients Enrolled
NRG OncologyLead Sponsor
231 Previous Clinical Trials
98,802 Total Patients Enrolled
Neil B DesaiPrincipal InvestigatorNRG Oncology

Media Library

Bicalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05050084 — Phase 3
Prostate Adenocarcinoma Research Study Groups: Arm IV (RT, ADT, darolutamide), Arm I (RT), Arm II (RT, ADT), Arm III (RT, ADT)
Prostate Adenocarcinoma Clinical Trial 2023: Bicalutamide Highlights & Side Effects. Trial Name: NCT05050084 — Phase 3
Bicalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05050084 — Phase 3
Prostate Adenocarcinoma Patient Testimony for trial: Trial Name: NCT05050084 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other scientific studies have included Radiation Therapy as a treatment method?

"The first formal research on Radiation Therapy occurred in 1995 at the National Institutes of Health Clinical Center. In the 25 years since the initial study, there have been 507 completed studies with 182 still active. A large portion of these ongoing trials are based in Frankford, Delaware."

Answered by AI

Are there long-term risks associated with Radiation Therapy?

"Radiation Therapy has been studied enough to know that it is effective and safe, so it received a score of 3."

Answered by AI

Are there a lot of places around the country where this research is being conducted?

"There are a total of 100 spots open for this trial at locations like Beebe South Coastal Health Campus in Frankford, Memorial Sloan Kettering Westchester in Harrison, Gene Upshaw Memorial Tahoe Forest Cancer Center in Truckee, and others."

Answered by AI

What cancerous cells does Radiation Therapy commonly target?

"Radiation therapy can help patients with dietary and nutritional therapies, stage t2b carcinoma of the prostate, and acute kidney failure."

Answered by AI

Are people with the condition being studied currently able to participate in the trial?

"The clinical trial is recruiting patients, with the posting date being 2021-11-03 and the most recent edit on 2022-09-06, according to clinicaltrials.gov."

Answered by AI

What is the projected total number of individuals who will participate in this trial?

"Yes, the trial is still open for enrolment according to the most recent information available on clinicaltrials.gov. The listing was created on 2021-11-03 and was last updated on 2022-09-06. So far, the study has recruited 2050 participants from 100 different sites."

Answered by AI

What are the goals that this clinical trial is hoping to achieve?

"The purpose of this study is to compare the effectiveness of two different treatments for cancer patients. The study will assess the patients over a five-year period to see if one treatment leads to better outcomes in terms of preventing the spread of cancer or increasing survival rates. Additionally, the study will measure fatigue levels to see if one treatment leads to less fatigue for patients."

Answered by AI

Who else is applying?

What state do they live in?
California
Pennsylvania
What site did they apply to?
Rutgers Cancer Institute of New Jersey
Kaiser Permanente-Walnut Creek
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I don't know.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score
2021. "Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05050084.
All > Canada Prostate Cancer
~1367 spots leftby Apr 2032
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top