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Radiotherapy + Enzalutamide for Recurrent Prostate Cancer (STEEL Trial)

Phase 2
Waitlist Available
Led By Edwin Posadas, 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization to the date of progression, death from any cause or last known follow-up date, assessed up to 5 years.
Awards & highlights

STEEL Trial 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.Check my eligibility
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.See study design
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.

STEEL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer has spread to the seminal vesicles.
Select...
My prostate cancer surgery showed cancer in nearby lymph nodes.
Select...
My PSA levels remained high after prostate surgery.
Select...
My cancer is considered aggressive (stage higher than pT3b).

STEEL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization to the date of progression, death from any cause or last known follow-up date, assessed up to 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization to the date of progression, death from any cause or last known follow-up date, assessed up to 5 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
Progression-Free Survival (PFS)

STEEL Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Salvage Radiation Therapy + Enhanced ADTExperimental Treatment3 Interventions
Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog + 24 months of enzalutamide.
Group II: Salvage Radiation Therapy + Standard ADTActive Control3 Interventions
Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog with or without 1-4 months of bicalutamide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Enzalutamide
2014
Completed Phase 4
~2760
GnRH analog
2017
N/A
~140

Find a Location

Who is running the clinical trial?

RTOG Foundation, Inc.Lead Sponsor
6 Previous Clinical Trials
1,324 Total Patients Enrolled
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,686 Total Patients Enrolled
41 Trials studying Prostate Cancer
12,181 Patients Enrolled for Prostate Cancer
Astellas Pharma IncIndustry Sponsor
691 Previous Clinical Trials
232,026 Total Patients Enrolled
35 Trials studying Prostate Cancer
8,454 Patients Enrolled for Prostate Cancer

Media Library

Prostate Cancer Clinical Trial 2023: Salvage Radiotherapy Highlights & Side Effects. Trial Name: NCT03809000 — Phase 2

Frequently Asked Questions

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

Does this research build on previous findings?

"Research into Radiation Therapy began in the year 2000 with a trial sponsored by AstraZeneca. This first study, which included 600 participants, led to Phase 3 approval for the use of radiation as therapy. As of now, there are 388 active studies being conducted in 2289 different cities across 64 countries."

Answered by AI

What are some of the most common diseases that Radiation Therapy can help improve?

"Radiation therapy can provide relief for patients experiencing cervical syndrome, therapeutic procedure, and minor burns."

Answered by AI

What is the FDA's opinion on Radiation Therapy?

"While there is some data supporting the safety of radiation therapy, none of it points to efficacy. Therefore, our team has given it a score of 2."

Answered by AI

What is the historical precedent for this form of treatment?

"Centre de Recherche Clinique du CHUS first began studying Radiation Therapy in the year 2000. Since then, 1276 separate trials have been completed with 388 more currently underway. There is a high concentration of active research in Farmington Hills, Michigan."

Answered by AI

How many people fit the bill to participate in this clinical trial?

"In order to move forward with this research, 242 eligible individuals must sign-up. From there, patients will be able to choose from a list of locations including 21st Century Oncology MHP - Farmington in Farmington Hills, Michigan and Arizona Center for Cancer Care - Gilbert in Gilbert, Arizona."

Answered by AI

How many testing facilities are involved with this research?

"One hundred different research sites are running this trial, with locations in Farmington Hills, Gilbert and Syracuse. Additionally, there are 100 other sites located throughout different cities. If you enroll in the study, selecting a site nearest to your location will reduce travel requirements."

Answered by AI

Are people signing up for this experiment currently?

"According to the latest information on clinicaltrials.gov, this trial is still recruiting patients. It was originally posted on April 15th, 2019 and has had 17 updates since then."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
65+
What site did they apply to?
SUNY Upstate Medical University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have Reoccurring prostate cancer that has metastasize to the Bone. T11 Spine and a rib.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
2019. "A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03809000.
All > Vermont > Paid Studies Maine
~31 spots leftby Apr 2025
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