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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until t > 200 ng/dl, assessed up to 11 years

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

~5410

Degarelix

2002

Completed Phase 3

~3730