A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery

Prostate Cancer Clinical Trial

— STEEL  

Official title:

STEEL: A Randomized Phase II Trial of Salvage Radiotherapy With Standard vs Enhanced Androgen Deprivation Therapy (With Enzalutamide) in Patients With Post-Prostatectomy PSA Recurrences With Aggressive Disease Features

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03809000
• Other study ID #: RTOG 3506
• Secondary ID: STEEL
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 15, 2019
• Est. completion date: September 15, 2029

Study information

• Verified date: February 2024
• Source: RTOG Foundation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

PRIMARY OBJECTIVE:

To determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog, will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: September 15, 2029
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathologically (histologically) proven adenocarcinoma confirmed by prostatectomy performed within 10 years prior to registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted.

• PSA level (= 0.2 ng/mL) within 120 days prior to registration. Patients must have a PSA = 0.2 ng/mL prior to starting ADT. For patients being followed by an ultrasensitive PSA assay, a serum PSA concentration of = 0.10 ng/mL will be considered eligible.

• GnRH analog may be started no more than 42 days prior study entry.

• Hemoglobin = 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration.

• Platelet count = 75,000 x 10^9/µL independent of transfusion and/or growth factors within 90 days prior to registration.

• At least 1 of the following aggressive features:

• Gleason score of 8-10 (note any Gleason score is eligible)

• 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)

• Persistently elevated PSA post-RP nadir (PEPP) defined as PSA > 0.1 ng/mL after radical prostatectomy

• PSA = 0.7 ng/mL

• Serum albumin = 3.0 g/dL within 90 days prior to registration

• GFR =35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to registration.

• Serum total bilirubin =1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is =1.5 × ULN, subject is eligible) within 90 days prior to registration.

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

• History and physical with ECOG Performance Status 0-1 or within 90 days prior to registration.

Exclusion Criteria:

• Definitive clinical or radiologic evidence of metastatic disease with the exception of locoregional lymph nodes.

• Prior invasive malignancy (except non-melanomatous skin cancer carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years).

• Prior systemic chemotherapy for the study cancer. Note: prior chemotherapy for a different cancer is allowable.

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

• History of any of the following:

• Documented inflammatory bowel disease

• Transmural myocardial infarction within the last 4 months prior to registration.

• New York Heart Association Functional Classification III/IV within 4 months prior to registration.

• Unstable angina and/or congestive heart failure requiring hospitalization within the last 4 months prior to registration

• History of loss of consciousness or transient ischemic attack within 12 months prior to randomization

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

• History of uncontrolled hypertension defined as a sustained systolic blood pressure in excess of 150 mmHg or a sustained diastolic blood pressure in excess of 90 mmHg despite optimized antihypertensive therapy.

• History of repeated falls and fractures over the past 12 months that in the opinion of the treating investigator would put the patient at risk for poor bone outcomes from androgen receptor targeted therapy

• Known gastrointestinal disorder affecting absorption of oral medications.

• Active uncontrolled infection defined as an identified infectious condition that requires active therapy that has not yet been completed.

• HIV positive patients with CD4 count < 200 cells/microliter within 30 days prior to registration OR HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count. Note: HIV testing is not required for eligibility for this protocol as it is self-reported. This exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive and/or interact with HAART.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Radiation Therapy
Radiation Therapy

Drug:
• Enzalutamide
Anti-androgen
• Bicalutamide
Anti-androgen
• GnRH analog
Anti-androgen

Locations

Country	Name	City	State
Canada	CHU de Quebec - L'Hotel-Dieu de Quebec	Québec City	Quebec
Canada	CIUSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke-Fleurimont	Sherbrooke
United States	American Fork Hospital	American Fork	Utah
United States	Aspirus Langlade Hospital	Antigo	Wisconsin
United States	Coastal Cancer Treatment Center - Bath	Bath	Maine
United States	Waldo Count General Hospital - Belfast	Belfast	Maine
United States	Maine Health/SMHC Cancer Care and Blood Disorders-Biddeford	Biddeford	Maine
United States	McLaren Cancer Institute - Bloomfield	Bloomfield	Michigan
United States	Cedar City Hospital	Cedar City	Utah
United States	Rush University Medical Center	Chicago	Illinois
United States	21st Century Oncology MHP - Clarkston	Clarkston	Michigan
United States	McLaren Cancer Institute - Clarkston	Clarkston	Michigan
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	UT Southwestern/Simmons Cancer Center - Dallas	Dallas	Texas
United States	William Beaumont Hospital - Dearborn	Dearborn	Michigan
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Wayne State/Karmanos Cancer Institute	Detroit	Michigan
United States	Crossroads Cancer Center	Effingham	Illinois
United States	WellSpan Health - Ephrata Cancer Center	Ephrata	Pennsylvania
United States	Exeter Hospital	Exeter	New Hampshire
United States	21st Century Oncology MHP - Farmington	Farmington Hills	Michigan
United States	McLaren Cancer Institute - Flint	Flint	Michigan
United States	Singh and Arora Hematology Oncology PC	Flint	Michigan
United States	University of Florida Health Science Center	Gainesville	Florida
United States	WellSpan Health - Adams Cancer Center	Gettysburg	Pennsylvania
United States	Arizona Center for Cancer Care - Gilbert	Gilbert	Arizona
United States	Valley View Hospital Cancer Center	Glenwood Springs	Colorado
United States	Marin Cancer Care, Inc.	Greenbrae	California
United States	Marin Health Medical Center	Greenbrae	California
United States	Gibbs Cancer Center - Pelham	Greer	South Carolina
United States	Sentara Cancer Institute at Sentara CarePlex Hospital	Hampton	Virginia
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University Cancer Center Johnson Creek	Johnson Creek	Wisconsin
United States	Kansas University Cancer Center North	Kansas City	Missouri
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	McLaren Cancer Institute - Greater Lansing	Lansing	Michigan
United States	Mid-Michigan Physicians - Lansing	Lansing	Michigan
United States	McLaren Cancer Institute - Lapeer Region	Lapeer	Michigan
United States	Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	WellSpan Health - Sechler Family Cancer Center	Lebanon	Pennsylvania
United States	Kansas University Cancer Center Lee's Summit	Lee's Summit	Missouri
United States	Logan Regional Medical Center	Logan	Utah
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	USC Medical Center - Los Angeles County	Los Angeles	California
United States	21st Century Oncology MHP - Macomb	Macomb	Michigan
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	21st Century Oncology MHP - Madison Heights	Madison Heights	Michigan
United States	Minnesota Oncology Hematology PA - Maplewood	Maplewood	Minnesota
United States	Loyola University Medical Center	Maywood	Illinois
United States	Froedtert Menomonee Falls Hospital	Menomonee Falls	Wisconsin
United States	East Jefferson General Hospital	Metairie	Louisiana
United States	LSU Healthcare Network/Metairie Multi-Specialty Clinic	Metairie	Louisiana
United States	Froedtert Hospital & the Medical College of Wisconsin	Milwaukee	Wisconsin
United States	McLaren Cancer Institute - Macomb	Mount Clemens	Michigan
United States	McLaren Cancer Institute - Central Michigan	Mount Pleasant	Michigan
United States	Intermountain Medical Center	Murray	Utah
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Maine Health/Stephens Memorial - Norway	Norway	Maine
United States	Drexel Town Square	Oak Creek	Wisconsin
United States	University Physicians at Oneida	Oneida	New York
United States	Upstate Cancer Center Radiation Oncology at Oneida	Oneida	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	University Physicians at Oswego	Oswego	New York
United States	Upstate Cancer Radiation Oncology at Oswego	Oswego	New York
United States	Kansas University Cancer Center Overland Park	Overland Park	Kansas
United States	McLaren Cancer Institute - Owosso	Owosso	Michigan
United States	Arizona Center for Cancer Care - Peoria	Peoria	Arizona
United States	McLaren Cancer Institute - Northern Michigan	Petoskey	Michigan
United States	Arizona Center for Cancer Care - Phoenix	Phoenix	Arizona
United States	University of Pittsburgh Medical Center - Shadyside Hospital	Pittsburgh	Pennsylvania
United States	McLaren Cancer Institute - Port Huron	Port Huron	Michigan
United States	Maine Medical Center - Bramhall S Portland	Portland	Maine
United States	Utah Valley Regional Medical Center	Provo	Utah
United States	Rex Cancer Center of Wakefield	Raleigh	North Carolina
United States	UNC Rex Cancer Center	Raleigh	North Carolina
United States	Penobscot Bay Medical Center - Rockport	Rockport	Maine
United States	Roseville Radiation Oncology Center	Roseville	California
United States	Sutter Roseville Medical Center	Roseville	California
United States	William Beaumont Hospital - Royal Oak	Royal Oak	Michigan
United States	Sutter Medical Center Sacramento	Sacramento	California
United States	Coborn Cancer Center	Saint Cloud	Minnesota
United States	Dixie Regional Medical Center	Saint George	Utah
United States	Dartmouth Hitchcock Medical Center/Norris Cancer Ctr. - St. Johnsbury	Saint Johnsbury	Vermont
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	HealthPartners, Inc.	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	University of California, San Francisco	San Francisco	California
United States	Maine Health CC of York County - Sanford	Sanford	Maine
United States	Maine Health/SMHCancer Care and Blood Disorders - Sanford	Sanford	Maine
United States	Nancy N. & J.C. Lewis Cancer & Research Pavilion	Savannah	Georgia
United States	Maine Medical Cancer Center - Scarborough Campus	Scarborough	Maine
United States	Arizona Center for Cancer Care - Scottsdale East	Scottsdale	Arizona
United States	Arizona Center for Cancer Care - Scottsdale North	Scottsdale	Arizona
United States	Maine Medical Partners - South Portland	South Portland	Maine
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	William Beaumont Hospital - Troy	Sterling Heights	Michigan
United States	Arizona Center for Cancer Care - Surprise	Surprise	Arizona
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Upstate Cancer Center at Hill Radiation Oncology	Syracuse	New York
United States	Moffitt Cancer Center	Tampa	Florida
United States	21st Century Oncology MHP - Troy	Troy	Michigan
United States	Sentara Virginia Beach General Hospital	Virginia Beach	Virginia
United States	Aspirus Regional Cancer Center	Wausau	Wisconsin
United States	Froedtert West Bend Hospital	West Bend	Wisconsin
United States	Kansas University Cancer Center Westwood	Westwood	Kansas
United States	Aspirus Cancer Care - Wisconsin Rapids	Wisconsin Rapids	Wisconsin
United States	WellSpan Health - York Hospital	York	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
RTOG Foundation, Inc.	Astellas Pharma Inc, Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	The time from the date of randomization to the date of progression, death from any cause or last known follow-up date.	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.