Radiotherapy + Enzalutamide for Recurrent Prostate Cancer

(STEEL Trial)

Recruiting at107 trial locations

Overseen by Edwin Posadas, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: RTOG Foundation, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

Research Team

Hiram Gay, MD

Principal Investigator

RTOG Foundation

Edwin Posadas, MD

Principal Investigator

RTOG Foundation

Eligibility Criteria

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.

Inclusion Criteria

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN within 90 days prior to registration

My PSA level is at least 0.2 ng/mL, or 0.1 ng/mL with an ultrasensitive test.

My prostate cancer has spread to the seminal vesicles.

Exclusion Criteria

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

You have a history of falling and breaking bones multiple times in the past year, and the doctor thinks that taking certain medications could make your bones weaker.

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

Treatment Details

Interventions

• Bicalutamide (Antiandrogen)
• Enzalutamide (Antiandrogen)
• Salvage Radiotherapy (Radiation)

Trial Overview 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.

Participant Groups

Group I: Salvage Radiation Therapy + Enhanced ADT Experimental Treatment 3 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 Control 3 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.

Who Is Running the Clinical Trial?

RTOG Foundation, Inc.

Lead Sponsor

Trials

7

Recruited

1,500+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Astellas Pharma Inc

Industry Sponsor

Trials

700

Recruited

236,000+

Headquarters

Tokyo, Japan

Top Products

- Xtandi (enzalutamide) for prostate cancer, - Xospata (gilteritinib) for AML, - Padcev (enfortumab vedotin) for bladder cancer, - Prograf (tacrolimus) for organ rejection prevention

Tadaaki Taniguchi

Astellas Pharma Inc

Chief Medical Officer since 2023

MD, PhD

Naoki Okamura

Astellas Pharma Inc

Chief Executive Officer since 2023

University of Tokyo, Faculty of Pharmacy