Arizona Center for Cancer Care - Gilbert |
Gilbert, Arizona, United States, 85297 |
Contact: Tina Bush 623-414-4921 tbush@arizonaccc.com |
Principal Investigator: Terry Lee, MD |
Arizona Center for Cancer Care - Peoria |
Peoria, Arizona, United States, 85381 |
Contact: Tina Bush 623-414-4921 tbush@arizonaccc.com |
Principal Investigator: Terry Lee, MD |
Arizona Center for Cancer Care - Phoenix |
Phoenix, Arizona, United States, 85027 |
Contact: Tina Bush 623-414-4921 tbush@arizonaccc.com |
Principal Investigator: Terry Lee, MD |
Arizona Center for Cancer Care - Scottsdale East |
Scottsdale, Arizona, United States, 85251 |
Contact: Tina Bush 623-414-4921 tbush@arizonaccc.com |
Principal Investigator: Terry Lee, MD |
Arizona Center for Cancer Care - Scottsdale North |
Scottsdale, Arizona, United States, 85258 |
Contact: Tina Bush 623-414-4921 tbush@arizonaccc.com |
Principal Investigator: Terry Lee, MD |
Arizona Center for Cancer Care - Surprise |
Surprise, Arizona, United States, 85374 |
Contact: Tina Bush 623-414-4921 tbush@arizonaccc.com |
Principal Investigator: Terry Lee, MD |
Marin Cancer Care, Inc. |
Greenbrae, California, United States, 94904 |
Contact: Jaime Chang 415-925-5040 jchang@marincancercare.com |
Principal Investigator: Llyod Miyawaki, MD |
Marin Health Medical Center |
Greenbrae, California, United States, 94904 |
Contact: Jaime Chang 415-925-5040 jchang@marincancercare.com |
Principal Investigator: Lloyd Miyawaki, MD |
University of Southern California |
Los Angeles, California, United States, 90033 |
Contact: Shamim Jhimlee 323-865-3071 shamim.jhimlee@med.usc.edu |
Principal Investigator: Leslie Ballas, MD |
USC Medical Center - Los Angeles County |
Los Angeles, California, United States, 90033 |
Contact: Shamim Jhimlee 323-865-3071 shamim.jhimlee@med.usc.edu |
Principal Investigator: Leslie Ballas, MD |
Cedars-Sinai Medical Center |
Los Angeles, California, United States, 90048 |
Contact: Jenica Custodio 310-423-0277 Jenica.Custodio@cshs.org |
Principal Investigator: Howard Sandler, MD |
Roseville Radiation Oncology Center |
Roseville, California, United States, 95661 |
Contact: Michele Pierini 916-454-6994 pierinmm@sutterhealth.org |
Principal Investigator: Christopher Jones, MD |
Sutter Roseville Medical Center |
Roseville, California, United States, 95661 |
Contact: Michele Pierini 916-454-6994 pierinimm@sutterhealth.org |
Principal Investigator: Christopher Jones, MD |
Sutter Medical Center Sacramento |
Sacramento, California, United States, 95816 |
Contact: Michele Pierini 916-454-6994 Pierinimm@sutterhealth.org |
Principal Investigator: Christopher Jones, MD |
Valley View Hospital Cancer Center |
Glenwood Springs, Colorado, United States, 81601 |
Contact: Cheryl Page 970-384-7574 cheryl.page@vvh.org |
Principal Investigator: Peter Rossi, MD |
University of Florida Health Science Center |
Gainesville, Florida, United States, 32608 |
Contact: John Lybarger 352-733-0489 lybarjm@ufl.edu |
Principal Investigator: Brian Ramnaraign, MD |
Nancy N. & J.C. Lewis Cancer & Research Pavilion |
Savannah, Georgia, United States, 31405 |
Contact: Carla Meyers 912-819-8236 meyersc@sjchs.org |
Principal Investigator: John Pablo, MD |
Decatur Memorial Hospital |
Decatur, Illinois, United States, 62526 |
Contact: Dianna Richardson 217-876-4760 drichardson@dmhhs.org |
Principal Investigator: Harold Yoon, MD |
Crossroads Cancer Center |
Effingham, Illinois, United States, 62401 |
Contact: Dianna Richardson 217-876-4760 drichardson@dmhhs.org |
Principal Investigator: Harold Yoon, MD |
Loyola University Medical Center |
Maywood, Illinois, United States, 60153 |
Contact: Vlora Osmani vlora.osmani@luhs.org |
Principal Investigator: Abshishek Solanki, MD |
University of Kansas Cancer Center |
Kansas City, Kansas, United States, 66160 |
Contact: Jeffrey Smith 913-588-3083 jsmith41@kumc.edu |
Principal Investigator: Xinglei Shen, MD |
Kansas University Cancer Center Overland Park |
Overland Park, Kansas, United States, 66210 |
Contact: Jeffrey Smith 913-588-3083 jsmith41@kumc.edu |
Principal Investigator: Xinglei Shen, MD |
Kansas University Cancer Center Westwood |
Westwood, Kansas, United States, 66205 |
Contact: Jeffrey Smith 913-588-3083 jsmith41@kumc.edu |
Principal Investigator: Xinglei Shen, MD |
Coastal Cancer Treatment Center - Bath |
Bath, Maine, United States, 04530 |
Contact: Jennifer Dalton, RN 207-294-8291 jdalton@mmc.org |
Principal Investigator: Matthew Cheney, MD |
Waldo Count General Hospital - Belfast |
Belfast, Maine, United States, 04915 |
Contact: Jennifer Dalton, RN 207-294-8291 jdalton@mmc.org |
Principal Investigator: Matthew Cheney, MD |
Maine Health/SMHC Cancer Care and Blood Disorders-Biddeford |
Biddeford, Maine, United States, 04005 |
Contact: Jennifer Dalton, RN 207-294-8291 jdalton@mmc.org |
Principal Investigator: Matthew Cheney, MD |
Maine Health/Stephens Memorial - Norway |
Norway, Maine, United States, 04268 |
Contact: Jennifer Dalton, RN 207-294-8291 |
Principal Investigator: Matthew Cheney, MD |
Maine Medical Center - Bramhall S Portland |
Portland, Maine, United States, 04102 |
Contact: Jennifer Dalton, RN 207-294-8291 jdalton@mmc.org |
Principal Investigator: Matthew Cheney, MD |
Penobscot Bay Medical Center - Rockport |
Rockport, Maine, United States, 04856 |
Contact: Jennifer Dalton, RN 207-294-8291 jdalton@mmc.org |
Principal Investigator: Matthew Dalton, MD |
Maine Health CC of York County - Sanford |
Sanford, Maine, United States, 04073 |
Contact: Jennifer Dalton, RN 207-294-8291 jdalton@mmc.org |
Principal Investigator: Matthew Cheney, MD |
Maine Health/SMHCancer Care and Blood Disorders - Sanford |
Sanford, Maine, United States, 04073 |
Contact: Jennifer Dalton, RN 207-294-8291 jdalton@mmc.org |
Principal Investigator: Matthew Cheney, MD |
Maine Medical Cancer Center - Scarborough Campus |
Scarborough, Maine, United States, 04074 |
Contact: Jennifer Dalton, RN 207-294-8291 jdalton@mmc.org |
Principal Investigator: Matthew Cheney, MD |
Maine Medical Partners - South Portland |
South Portland, Maine, United States, 04106 |
Contact: Jennifer Dalton, RN 207-294-8291 jdalton@mmc.org |
Principal Investigator: Matthew Cheney, MD |
McLaren Cancer Institute - Bloomfield |
Bloomfield, Michigan, United States, 48302 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Kiran Devisetty, MD |
21st Century Oncology MHP - Clarkston |
Clarkston, Michigan, United States, 48346 |
Contact: Rudolf Ross 941-833-5700 rudi.ross@21co.com |
Principal Investigator: Thomas Boike, MD |
McLaren Cancer Institute - Clarkston |
Clarkston, Michigan, United States, 48346 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Kiran Devisetty, MD |
William Beaumont Hospital - Dearborn |
Dearborn, Michigan, United States, 48124 |
Contact: Melissa Lurie 248-551-0735 melissa.lurie@beaumont.org |
Principal Investigator: Daniel Krauss, MD |
Wayne State/Karmanos Cancer Institute |
Detroit, Michigan, United States, 48201 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Kiran Devisetty, MD |
21st Century Oncology MHP - Farmington |
Farmington Hills, Michigan, United States, 48334 |
Contact: Rudolf Ross 941-833-5700 rudi.ross@21co.com |
Principal Investigator: Thomas Boike, MD |
McLaren Cancer Institute - Flint |
Flint, Michigan, United States, 48532 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Amit Bhatt, MD |
Singh and Arora Hematology Oncology PC |
Flint, Michigan, United States, 48532 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Amit Bhatt, MD |
McLaren Cancer Institute - Greater Lansing |
Lansing, Michigan, United States, 48910 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Amit Bhatt, MD |
Mid-Michigan Physicians - Lansing |
Lansing, Michigan, United States, 48912 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Amit Bhatt, MD |
McLaren Cancer Institute - Lapeer Region |
Lapeer, Michigan, United States, 48446 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Amit Bhatt, MD |
21st Century Oncology MHP - Macomb |
Macomb, Michigan, United States, 48044 |
Contact: Rudolf Ross 941-833-5700 rudi.ross@21co.com |
Principal Investigator: Thomas Boike, MD |
21st Century Oncology MHP - Madison Heights |
Madison Heights, Michigan, United States, 48071 |
Contact: Rudolf Ross 941-833-5700 rudi.ross@21co.com |
Principal Investigator: Thomas Boike, MD |
McLaren Cancer Institute - Macomb |
Mount Clemens, Michigan, United States, 48043 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Amit Bhatt, MD |
McLaren Cancer Institute - Central Michigan |
Mount Pleasant, Michigan, United States, 48858 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Amit Bhatt, MD |
McLaren Cancer Institute - Owosso |
Owosso, Michigan, United States, 48867 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Amit Bhatt, MD |
McLaren Cancer Institute - Northern Michigan |
Petoskey, Michigan, United States, 49770 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Amit Bhatt, MD |
McLaren Cancer Institute - Port Huron |
Port Huron, Michigan, United States, 48060 |
Contact: Delaney Erickson 313-576-8029 ericksod@karmanos.org |
Principal Investigator: Amit Bhatt, MD |
William Beaumont Hospital - Royal Oak |
Royal Oak, Michigan, United States, 48073 |
Contact: Melissa Lurie 248-551-0735 melissa.lurie@beaumont.org |
Principal Investigator: Daniel Krauss, MD |
William Beaumont Hospital - Troy |
Sterling Heights, Michigan, United States, 48314 |
Contact: Melissa Lurie 248-551-0735 melissa.lurie@beaumont.org |
Principal Investigator: Daniel Krauss, MD |
21st Century Oncology MHP - Troy |
Troy, Michigan, United States, 48098 |
Contact: Rudolf Ross 941-833-5700 rudi.ross@21co.com |
Principal Investigator: Thomas Boike, MD |
Mercy Hospital |
Coon Rapids, Minnesota, United States, 55433 |
Contact: Michael Kelly 952-993-1517 michael.kelly@parknicollet.comcom |
Principal Investigator: Ryan Funk, MD |
Minnesota Oncology Hematology PA - Maplewood |
Maplewood, Minnesota, United States, 55109 |
Contact: Michael Kelly 952-993-1517 michael.kelly@parknicollet.com |
Principal Investigator: Ryan Funk, MD |
Coborn Cancer Center |
Saint Cloud, Minnesota, United States, 56303 |
Contact: Stacy St. Onge 320-229-5199 ext 70826 stacy.stonge@centracare.com |
Principal Investigator: Donald Jurgens, MD |
HealthPartners, Inc. |
Saint Louis Park, Minnesota, United States, 55416 |
Contact: Michael Kelly 952-993-1517 michael.kelly@parknicollet.com |
Principal Investigator: Ryan Funk, MD |
Regions Hospital |
Saint Paul, Minnesota, United States, 55101 |
Contact: Michael Kelly 952-993-1517 michael.kelly@parknicollet.com |
Principal Investigator: Ryan Funk, MD |
Kansas University Cancer Center North |
Kansas City, Missouri, United States, 64154 |
Contact: Jeffrey Smith 913-588-3083 jsmith41@kumc.edu |
Principal Investigator: Xinglei Shen, MD |
Kansas University Cancer Center Lee's Summit |
Lee's Summit, Missouri, United States, 64064 |
Contact: Jeffrey Smith 913-588-3083 jsmith41@kumc.edu |
Principal Investigator: Xinglei Shen, MD |
Washington University School of Medicine |
Saint Louis, Missouri, United States, 63110 |
Contact: Paige Lampe 314-273-3925 lampepe@wustl.edu |
Principal Investigator: Hiram Gay, MD |
Exeter Hospital |
Exeter, New Hampshire, United States, 03833 |
Contact: Julie Bushey 603-580-6148 jbushey@ehr.org |
Principal Investigator: Gary Proulx, MD |
Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center |
Lebanon, New Hampshire, United States, 03756 |
Contact: Sharon Schoville 603-650-6056 sharon.r.schoville@hitchcock.org |
Principal Investigator: Alan Hartford, MD |
University Physicians at Oneida |
Oneida, New York, United States, 13421 |
Contact: Erin Bingham 315-464-3603 binghame@upstate.edu |
Principal Investigator: Jeffrey Bogart, MD |
Upstate Cancer Center Radiation Oncology at Oneida |
Oneida, New York, United States, 13421 |
Contact: Erin Bingham 315-464-3603 binghame@upstate.edu |
Principal Investigator: Jeffrey Bogart, MD |
University Physicians at Oswego |
Oswego, New York, United States, 13126 |
January 16, 2019
|
January 18, 2019
|
April 26, 2021
|
April 15, 2019
|
September 15, 2024 (Final data collection date for primary outcome measure)
|
Progression-Free Survival (PFS) [ Time Frame: 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. ] The time from the date of randomization to the date of progression, death from any cause or last known follow-up date.
|
Same as current
|
|
Not Provided
|
Not Provided
|
Not Provided
|
Not Provided
|
|
A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
|
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
|
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.
|
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.
|
Interventional
|
Phase 2
|
Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
|
Prostate Cancer
|
- Radiation: Radiation Therapy
Radiation Therapy
Other Names:
- RT
- Three-Dimensional Conformal Radiation Therapy (3D-CRT)
- Intensity-Modulated Radiation Therapy (IMRT)
- Image-Guided Radiation Therapy (IGRT)
- Radiotherapy
- Drug: Enzalutamide
Anti-androgen
Other Name: Xtandi®
- Drug: Bicalutamide
Anti-androgen
Other Name: Casodex®
- Drug: GnRH analog
Anti-androgen
Other Names:
- Gonadotropin-releasing hormone analog
- Lupron®
- leuprolide acetate
- goserelin acetate
- Eligard™
- Viadur™
- Zoldaex®
- Trelstar®
|
- Active Comparator: Salvage Radiation Therapy + Standard ADT
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.
Interventions:
- Radiation: Radiation Therapy
- Drug: Bicalutamide
- Drug: GnRH analog
- Experimental: Salvage Radiation Therapy + Enhanced ADT
Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog + 24 months of enzalutamide.
Interventions:
- Radiation: Radiation Therapy
- Drug: Enzalutamide
- Drug: GnRH analog
|
Not Provided
|
|
Recruiting
|
242
|
Same as current
|
September 15, 2029
|
September 15, 2024 (Final data collection date for primary outcome measure)
|
Inclusion Criteria:
Exclusion Criteria:
|
Sexes Eligible for Study: |
Male |
|
18 Years and older (Adult, Older Adult)
|
No
|
Contact: Edwin Posadas, MD |
310-423-7600 |
edwin.posadas@csmc.edu |
|
|
Canada, United States
|
|
|
NCT03809000
|
RTOG 3506 STEEL ( Other Identifier: RTOG Foundation )
|
Yes
|
Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
Product Manufactured in and Exported from the U.S.: |
No |
|
|
RTOG Foundation, Inc.
|
RTOG Foundation, Inc.
|
- Pfizer
- Astellas Pharma Inc
|
Principal Investigator: |
Edwin Posadas, MD |
RTOG Foundation |
Principal Investigator: |
Hiram Gay, MD |
RTOG Foundation |
|
RTOG Foundation, Inc.
|
April 2021
|
|