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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05241860
Other study ID # A032101
Secondary ID U10CA180821NCI-2
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 21, 2022
Est. completion date September 1, 2033

Study information

Verified date April 2024
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

PRIMARY OBJECTIVE: I. To determine the proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to >= 150 ng/ml) after treatment interruption. SECONDARY OBJECTIVES: I. To determine time to eugonadal testosterone (> 150 ng/dl). II. To determine duration off-treatment. III. To assess changes in quality of life as follows: 1. To assess changes in patient-reported quality of life as assessed by the Functional Assessment of Cancer Therapy- Prostate (FACT-P) total score from baseline to 24 months after treatment interruption. 2. To assess changes in the FACT-P subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to 24 months after treatment interruption. 3. To assess changes in the FACT-P total score and subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to the remaining post-baseline time points (i.e., 6, 12, and 18 months) after treatment interruption. OUTLINE: Patients 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 prostate specific antigen (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. After completion of study treatment, patients are followed up every 6 months for 10 years from registration or withdrawal from the study or death.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 79
Est. completion date September 1, 2033
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pharmacotherapy Discontinuation
Stop hormonal medications (Abiraterone, Enzalutamide, Apalutamide, Leuprolide, Goserelin, Degarelix, Relugolix)
Follow-Up
Undergo follow-up
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies

Locations

Country Name City State
United States Hickman Cancer Center Adrian Michigan
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Saint Anthony's Health Alton Illinois
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Community Hospital of Anaconda Anaconda Montana
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
United States Rocky Mountain Regional VA Medical Center Aurora Colorado
United States UM Sylvester Comprehensive Cancer Center at Aventura Aventura Florida
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Flaget Memorial Hospital Bardstown Kentucky
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Billings Clinic Cancer Center Billings Montana
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Elizabeth Boardman Hospital Boardman Ohio
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States McFarland Clinic - Boone Boone Iowa
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Bozeman Deaconess Hospital Bozeman Montana
United States Cox Cancer Center Branson Branson Missouri
United States Harrison Medical Center Bremerton Washington
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States University of Michigan - Brighton Center for Specialty Care Brighton Michigan
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Highline Medical Center-Main Campus Burien Washington
United States Fairview Ridges Hospital Burnsville Minnesota
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cambridge Medical Center Cambridge Minnesota
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Mercy Cancer Center ?? Carmichael Carmichael California
United States Mercy San Juan Medical Center Carmichael California
United States Caro Cancer Center Caro Michigan
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Saint Mary's Hospital Centralia Illinois
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Northwestern University Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Saint Francis Cancer Center Colorado Springs Colorado
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States Mercy Hospital Coon Rapids Minnesota
United States UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Greater Regional Medical Center Creston Iowa
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Dayton Blood and Cancer Center Dayton Ohio
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States Porter Adventist Hospital Denver Colorado
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Illinois CancerCare-Dixon Dixon Illinois
United States Epic Care-Dublin Dublin California
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Crossroads Cancer Center Effingham Illinois
United States Mercy Cancer Center - Elk Grove Elk Grove California
United States Bay Area Breast Surgeons Inc Emeryville California
United States Epic Care Partners in Cancer Care Emeryville California
United States Walter Knox Memorial Hospital Emmett Idaho
United States Saint Elizabeth Hospital Enumclaw Washington
United States Illinois CancerCare-Eureka Eureka Illinois
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Medical Center Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Sanford South University Medical Center Fargo North Dakota
United States Southpointe-Sanford Medical Center Fargo Fargo North Dakota
United States Parkland Health Center - Farmington Farmington Missouri
United States Saint Francis Hospital Federal Way Washington
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Dana-Farber Cancer Institute at Foxborough Foxboro Massachusetts
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Unity Hospital Fridley Minnesota
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Central Care Cancer Center - Garden City Garden City Kansas
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States CHI Health Saint Francis Grand Island Nebraska
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States Miami Valley Cancer Care and Infusion Greenville Ohio
United States Wayne Hospital Greenville Ohio
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Memorial Sloan Kettering Westchester Harrison New York
United States Ingalls Memorial Hospital Harvey Illinois
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States McFarland Clinic - Jefferson Jefferson Iowa
United States Capital Region Southwest Campus Jefferson City Missouri
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Kalispell Regional Medical Center Kalispell Montana
United States CHI Health Good Samaritan Kearney Nebraska
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States Monmouth Medical Center Southern Campus Lakewood New Jersey
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma
United States Saint Joseph Hospital Lexington Kentucky
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States CARTI Cancer Center Little Rock Arkansas
United States Littleton Adventist Hospital Littleton Colorado
United States Saint Barnabas Medical Center Livingston New Jersey
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Saint Joseph London London Kentucky
United States Monmouth Medical Center Long Branch New Jersey
United States Longmont United Hospital Longmont Colorado
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States Sovah Health Martinsville Martinsville Virginia
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin
United States Mercy UC Davis Cancer Center Merced California
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States UM Sylvester Comprehensive Cancer Center at Kendall Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Garnet Health Medical Center Middletown New York
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford Massachusetts
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Hospital Missoula Montana
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Monticello Cancer Center Monticello Minnesota
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Saint Joseph Mount Sterling Mount Sterling Kentucky
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Memorial Sloan Kettering Cancer Center New York New York
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States HSHS Saint Elizabeth's Hospital O'Fallon Illinois
United States Drexel Town Square Health Center Oak Creek Wisconsin
United States Bay Area Tumor Institute Oakland California
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Northwestern Medicine Orland Park Orland Park Illinois
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States Lake Regional Hospital Osage Beach Missouri
United States Upstate Cancer Center at Oswego Oswego New York
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Midlands Community Hospital Papillion Nebraska
United States Parker Adventist Hospital Parker Colorado
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Jefferson Methodist Hospital Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Fairview Northland Medical Center Princeton Minnesota
United States Illinois CancerCare-Princeton Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Eisenhower Medical Center Rancho Mirage California
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Reid Health Richmond Indiana
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mercy Cancer Center - Rocklin Rocklin California
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Mercy Cancer Center - Sacramento Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Siteman Cancer Center at Christian Hospital Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Welch Cancer Center Sheridan Wyoming
United States Memorial Hospital East Shiloh Illinois
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth Massachusetts
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States State University of New York Upstate Medical University Syracuse New York
United States SUNY Upstate Medical Center-Community Campus Syracuse New York
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Sanford Thief River Falls Medical Center Thief River Falls Minnesota
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Community Medical Center Toms River New Jersey
United States Dayton Physicians LLC - Troy Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Memorial Sloan Kettering Nassau Uniondale New York
United States Upstate Cancer Center at Verona Verona New York
United States Ridgeview Medical Center Waconia Minnesota
United States Epic Care Cyberknife Center Walnut Creek California
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Saint Joseph Warren Hospital Warren Ohio
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Illinois CancerCare - Washington Washington Illinois
United States Mercy Hospital Washington Washington Missouri
United States Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Rice Memorial Hospital Willmar Minnesota
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Woodland Memorial Hospital Woodland California
United States UMass Memorial Medical Center - University Campus Worcester Massachusetts
United States Sanford Cancer Center Worthington Worthington Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Time to eugonadal testosterone The median time to eugonadal testosterone (> 150 ng/dl) will be computed by the cumulative incidence function. Up to 10 years
Secondary Duration off-treatment The median time off-treatment. Up to 10 years
Secondary Radiographic progression-free survival The median time to radiographic progression or death (whichever occurs first) will be computed by the Kaplan-Meier estimator. Up to 10 years
Secondary Time to next treatment The median time to the first subsequent treatment will be computed by the cumulative incidence function. Up to 24 months
Secondary Overall survival The median survival time will be computed by the Kaplan-Meier estimator. Survival time defined as from treatment interruption per protocol to death due to any cause or censored at date last known alive. Assessed up to 10 years
Secondary Cancer-specific survival The median survival time will be computed by the cumulative incidence function. Cancer-specific survival as defined as from treatment interruption per protocol to death attributable to cancer or its treatment in the opinion of the treating investigator or censored at date last known alive. Assessed up to 10 years
Secondary Non-cancer specific survival The median survival time will be computed by the cumulative incidence function. Non-cancer-specific survival as defined as from treatment interruption per protocol to death not attributable to cancer or its treatment in the opinion of the treating investigator or censored at date last known alive. Up to 10 years
Secondary Prostate specific antigen (PSA) progression-free survival The median PSA progression free survival time will be computed by the Kaplan-Meier estimator. PSA progression free survival as defined as from treatment interruption per protocol to the first PSA failure (two consecutive increases in PSA of 25% and >= 2 ng/mL above nadir) or death. Assessed up to 10 years
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