Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)
A-DREAM
A Phase 2 Trial of ADT Interruption in Patients Responding Exceptionally to AR-Pathway Inhibitor in Metastatic Hormone-Sensitive Prostate Cancer (MHSPC): A-DREAM
3 other identifiers
interventional
79
1 country
326
Brief Summary
This phase II trial examines antiandrogen therapy interruptions in patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic) responding exceptionally well to androgen receptor-pathway inhibitor therapy. The usual treatment for patients with metastatic prostate cancer is to receive hormonal medications including a medication to decrease testosterone levels in the body and a potent oral hormonal medication to block growth signals from male hormones (like testosterone) in the cancer cells. Patients whose cancer is responding exceptionally well to this therapy may take a break from these medications according to their doctor's guidance. This trial may help doctors determine if stopping treatment can allow for testosterone recovery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2022
Longer than P75 for phase_2
326 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2022
CompletedFirst Posted
Study publicly available on registry
February 16, 2022
CompletedStudy Start
First participant enrolled
November 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2033
ExpectedDecember 22, 2025
December 1, 2025
2.9 years
January 31, 2022
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment-free with eugonadal testosterone (> 150 ng/dl)
The proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to \>= 150 ng/ml) after treatment interruption will be calculated for the study cohort.
At 18 months
Secondary Outcomes (8)
Time to eugonadal testosterone
Up to 10 years
Duration off-treatment
Up to 10 years
Radiographic progression-free survival
Up to 10 years
Time to next treatment
Up to 24 months
Overall survival
Assessed up to 10 years
- +3 more secondary outcomes
Study Arms (1)
Treatment (discontinue hormonal medication, follow up)
EXPERIMENTALPatients stop both hormonal medications (medication to decrease testosterone levels in the body and potent oral hormonal medication to block growth signals from male hormones in the cancer cells). Patients are then followed every 12 months for symptoms. Patients with an increase in PSA level to greater than or equal to 5 ng/ml, changes on imaging studies suggesting that their cancer is growing back, or symptoms that the doctor thinks is related to their cancer growing back, resume both hormonal treatments.
Interventions
Stop hormonal medications (Abiraterone, Enzalutamide, Apalutamide, Leuprolide, Goserelin, Degarelix, Relugolix)
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- Histologic or clinical diagnosis of metastatic prostate cancer
- Must have had evidence of metastatic disease by bone scan, or nodal or visceral lesions on computed tomography (CT) or magnetic resonance imaging (MRI) prior to starting on intense antiandrogen therapy (ADT)
- Radiographic evidence of disease is not required at the time of enrollment
- No metastases to liver or to brain, as these represent aggressive variant disease biology for which intermittent treatment may not be favored
- Must currently be receiving intense ADT for metastatic hormone sensitive prostate cancer (mHSPC)
- Testosterone suppression (TS) with luteinizing hormone releasing hormone (LHRH)-agonist or LHRH-antagonist AND
- An approved secondary androgen receptor pathway inhibitor (ARPI) abiraterone, enzalutamide, or apalutamide (or darolutamide if approved for this indication)
- Must have remained on testosterone suppression for metastatic disease continuously (without treatment breaks) for 540-750 days (approximately 18 to 24 months) from time of first dose of LHRH agonist or antagonist by time of registration. A period of anti-androgen treatment prior to LHRH agonist or antagonist initiation is not included in the 540 - 750 days (approximately 18 to 24 months)
- Must have received treatment with ARPI for at least 360 days in total by time of A032101 registration. Treatment breaks from ARPI of up to 28 days are permitted (for example peri-procedural or for management of a temporary adverse event) as long as PSA did not rise while holding therapy
- Prior TS in the context of neoadjuvant/concurrent/adjuvant treatment with local therapy is permitted. Prior course(s) of intermittent TS for biochemical-only recurrence is permitted. However, if the patient previously received TS, metastatic progression for which intense ADT was initiated must have occurred during an off-treatment interval and with testosterone \>= 150 ng/dL
- Prior local therapy for prostate cancer (either before or after diagnosis of metastatic disease) is permitted. Prior treatment with docetaxel chemotherapy for up to 6 cycles is permitted. Prior radiation therapy to metastatic sites (either for symptom palliation or for ablation of oligometastatic disease) is permitted
You may not qualify if:
- No history of surgical castration
- No history of ARPI use prior to diagnosis of mHSPC for which the patient is currently receiving intense ADT (such as in the neoadjuvant setting with prior local therapy)
- No current or prior treatment with experimental agents for metastatic hormone-sensitive prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Prior to initiating intense ADT
- Prostate specific antigen (PSA) \>= 5 ng/ml
- Testosterone \>= 150 ng/dl. Patients are permitted to enroll if testosterone was not measured prior to initiating intense ADT for mHSPC if they did not previously receive TS and were not known or suspected to be hypogonadal at the time
- At time of enrollment to A032101
- PSA \< 0.2 ng/ml
- \*\* PSA values (measured in the same laboratory) must be stable or falling for 3 consecutive measurements - i.e. any PSA rise must be followed by a decrease in PSA that is further decreased or stable on a 3rd measurement. Any patient with 2 consecutive rises in PSA values since achieving castrate level of testosterone is not eligible
- Testosterone \< 50 ng/dl
- No current participation in a clinical study that does not allow for TS or ARPI interruption
- No patients with a "currently active" second malignancy \* Patients with non-melanomatous skin cancer, superficial bladder cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (326)
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420, United States
Mercy Cancer Center �� Carmichael
Carmichael, California, 95608, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Epic Care-Dublin
Dublin, California, 94568, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758, United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
Epic Care Partners in Cancer Care
Emeryville, California, 94608, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
Mercy UC Davis Cancer Center
Merced, California, 95340, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
Mercy Cancer Center - Rocklin
Rocklin, California, 95765, United States
Mercy Cancer Center - Sacramento
Sacramento, California, 95816, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444, United States
Epic Care Cyberknife Center
Walnut Creek, California, 94597, United States
Woodland Memorial Hospital
Woodland, California, 95695, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Mercy Medical Center
Durango, Colorado, 81301, United States
Southwest Oncology PC
Durango, Colorado, 81301, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Walter Knox Memorial Hospital
Emmett, Idaho, 83617, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Cancer Clinic
Sandpoint, Idaho, 83864, United States
Saint Anthony's Health
Alton, Illinois, 62002, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Saint Mary's Hospital
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Memorial Hospital East
Shiloh, Illinois, 62269, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Reid Health
Richmond, Indiana, 47374, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
McFarland Clinic - Boone
Boone, Iowa, 50036, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503, United States
Greater Regional Medical Center
Creston, Iowa, 50801, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Mission Cancer and Blood - Laurel
Des Moines, Iowa, 50314, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530, United States
Flaget Memorial Hospital
Bardstown, Kentucky, 40004, United States
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701, United States
Saint Joseph Hospital
Lexington, Kentucky, 40504, United States
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504, United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509, United States
Saint Joseph London
London, Kentucky, 40741, United States
Saint Joseph Mount Sterling
Mount Sterling, Kentucky, 40353, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, 02035, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, 01757, United States
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, 02190, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655, United States
Hickman Cancer Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, 48116, United States
Saint Joseph Mercy Canton
Canton, Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Caro Cancer Center
Caro, Michigan, 48723, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346, United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346, United States
Ascension Saint John Hospital
Detroit, Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan, 48054, United States
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236, United States
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan, 48236, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan, 48044, United States
Michigan Breast Specialists-Macomb Township
Macomb, Michigan, 48044, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162, United States
21st Century Oncology-Pontiac
Pontiac, Michigan, 48341, United States
Hope Cancer Center
Pontiac, Michigan, 48341, United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, 48341, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, 48312, United States
Ascension Saint Joseph Hospital
Tawas City, Michigan, 48764, United States
Advanced Breast Care Center PLLC
Warren, Michigan, 48088, United States
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan, 48093, United States
Macomb Hematology Oncology PC
Warren, Michigan, 48093, United States
Michigan Breast Specialists-Warren
Warren, Michigan, 48093, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
Cambridge Medical Center
Cambridge, Minnesota, 55008, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Sanford Cancer Center Worthington
Worthington, Minnesota, 56187, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
Cox Cancer Center Branson
Branson, Missouri, 65616, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Capital Region Southwest Campus
Jefferson City, Missouri, 65109, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Lake Regional Hospital
Osage Beach, Missouri, 65065, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
Mercy Hospital Washington
Washington, Missouri, 63090, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Hospital
Missoula, Montana, 59804, United States
CHI Health Saint Francis
Grand Island, Nebraska, 68803, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Midlands Community Hospital
Papillion, Nebraska, 68046, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Garnet Health Medical Center
Middletown, New York, 10940, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Upstate Cancer Center at Oswego
Oswego, New York, 13126, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
SUNY Upstate Medical Center-Community Campus
Syracuse, New York, 13215, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Upstate Cancer Center at Verona
Verona, New York, 13478, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford South University Medical Center
Fargo, North Dakota, 58103, United States
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103, United States
Sanford Medical Center Fargo
Fargo, North Dakota, 58104, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431, United States
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247, United States
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Dayton Blood and Cancer Center
Dayton, Ohio, 45409, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Armes Family Cancer Center
Findlay, Ohio, 45840, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Orion Cancer Care
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Joseph Warren Hospital
Warren, Ohio, 44484, United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814, United States
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, 97914, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Jefferson Methodist Hospital
Philadelphia, Pennsylvania, 19148, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802, United States
Sovah Health Martinsville
Martinsville, Virginia, 24115, United States
Harrison Medical Center
Bremerton, Washington, 98310, United States
Highline Medical Center-Main Campus
Burien, Washington, 98166, United States
Saint Elizabeth Hospital
Enumclaw, Washington, 98022, United States
Saint Francis Hospital
Federal Way, Washington, 98003, United States
Saint Clare Hospital
Lakewood, Washington, 98499, United States
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, 98405, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Billings Clinic-Cody
Cody, Wyoming, 82414, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Atish D. Choudhury, MD, PhD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2022
First Posted
February 16, 2022
Study Start
November 21, 2022
Primary Completion
September 29, 2025
Study Completion (Estimated)
September 1, 2033
Last Updated
December 22, 2025
Record last verified: 2025-12