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Radiotherapy + Enzalutamide for Recurrent Prostate Cancer (STEEL Trial)

Phase 2

Waitlist Available

Led By Hiram Gay, MD

Research Sponsored by RTOG Foundation, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Seminal vesicle invasion (SVI) (note any pT stage [AJCC v8.0] is eligible but a pT stage ≥ pT3b is considered aggressive)

- Locoregional node involvement at radical prostatectomy (pN1)

Must not have

- History of seizure disorder or condition that may predispose to seizure (e.g. prior cortical stroke or significant brain trauma)

Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether radiation therapy and a stronger form of hormone therapy can improve survival for men with aggressive prostate cancer that has come back after surgery.

Who is the study for?

Men with recurrent prostate cancer after surgery, having a high Gleason score (8-10), elevated PSA levels, and certain aggressive disease features are eligible. They must have adequate blood counts and organ function. Exclusions include heart failure, metastatic disease, prior chemotherapy for prostate cancer, seizures or conditions predisposing to them, uncontrolled hypertension or infections, recent cardiovascular events or falls.

What is being tested?

The trial is testing whether adding the drug Enzalutamide to salvage radiation therapy and standard hormone therapy improves progression-free survival in men whose prostate cancer has returned post-surgery compared to just radiation and standard hormone therapy alone.

What are the potential side effects?

Enzalutamide may cause fatigue, back pain, constipation, joint pain or swelling. It can also affect blood pressure and mental acuity leading to falls or fractures. Radiation therapy might result in skin irritation at the treatment site as well as urinary issues like frequency or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has spread to the seminal vesicles.

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My prostate cancer surgery showed cancer in nearby lymph nodes.

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My PSA levels remained high after prostate surgery.

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My cancer is considered aggressive (stage higher than pT3b).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures or conditions that could lead to seizures.

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I've had radiation in the same area as my current cancer.

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I have a digestive condition that affects how my body absorbs pills.

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I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 4 months.

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I had a major heart attack in the last 4 months.

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I have not had a fainting spell or mini-stroke in the last year.

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My blood pressure remains high despite taking medication.

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My heart condition severely limits my physical activity.

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I am currently being treated for an infection that is not yet under control.

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I have been diagnosed with inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization to date of failure, death, or last known follow-up, whichever occurs first, at a minimum of two years from start of treatment, and up to six years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization to date of failure, death, or last known follow-up, whichever occurs first, at a minimum of two years from start of treatment, and up to six years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization to date of failure, death, or last known follow-up, whichever occurs first, at a minimum of two years from start of treatment, and up to six 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

Progression-Free Survival (Percentage of Participants Alive Without Progression)

Secondary study objectives

Alternative Biochemical Failure (Percentage of Participants With Alternative Biochemical Failure)

Biochemical Failure (Percentage of Participants With Biochemical Failure)

Cause-specific Mortality (Percentage of Participants Who Have Not Died Due to Prostate Cancer)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Salvage Radiation Therapy + Enhanced ADTExperimental Treatment3 Interventions

Enhanced ADT: 24 months of GnRH analog (any formulation) with 24 months of enzalutamide (160 mg/day). SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost.

Group II: Salvage Radiation Therapy (SRT) + Standard androgen deprivation therapy (ADT)Active Control3 Interventions

Standard ADT: 24 months of GnRH analog (any formulation) with optional 1-4 months of bicalutamide (50 mg/day). SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~3820

Radiation Therapy

2017

Completed Phase 3

~7250