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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
Must not have
Prior radiotherapy to prostate/pelvis region resulting in overlap of radiation therapy fields
Previous bilateral orchiectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until t > 200 ng/dl, assessed up to 11 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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
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I have chronic hepatitis B but it's under control with medication.
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My prostate cancer is at an intermediate stage but considered high risk.
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My white blood cell count is healthy.
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I am 18 years old or older.
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My kidney function, measured by creatinine clearance, is adequate.
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I had hepatitis C but have been successfully treated and cured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy to my prostate or pelvis area before.
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I have had both testicles surgically removed.
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I have not had any other cancer besides this one in the last 3 years.
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I have undergone hormonal therapy before.
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I had surgery or targeted treatment to cure my prostate cancer.
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My cancer has spread to other parts of my body.
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I am currently on testosterone replacement therapy.
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I cannot swallow pills.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Distant Metastasis (DM) (De-intensification study)
Metastasis-Free Survival (MFS) (Intensification study)
Secondary study objectives
Cognition
Distant Metastasis (DM) including PET imaging
Distant Metastasis (Intensification study)
+9 more
Other study objectives
Bowel and urinary function related quality of life
Cardio-metabolic markers
Castrate-resistant prostate cancer (CRPC)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~3730
Leuprolide
2008
Completed Phase 4
~19000
Bicalutamide
2003
Completed Phase 3
~6210
Triptorelin
2017
Completed Phase 4
~1560
Darolutamide
2018
Completed Phase 2
~100
Flutamide
2013
Completed Phase 4
~2110
Goserelin
2008
Completed Phase 3
~4270
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,893 Previous Clinical Trials
41,010,422 Total Patients Enrolled
NRG OncologyLead Sponsor
237 Previous Clinical Trials
100,724 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
~1367 spots leftby Apr 2032
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