Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM) (A-DREAM)
Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8
About this trial
This is an interventional treatment trial for Castration-Sensitive Prostate Carcinoma
Eligibility Criteria
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
Sites / Locations
- Cancer Center at Saint Joseph'sRecruiting
- Mercy Hospital Fort SmithRecruiting
- Mission Hope Medical Oncology - Arroyo GrandeRecruiting
- Mercy Cancer Center �� CarmichaelRecruiting
- Mercy San Juan Medical CenterRecruiting
- Epic Care-DublinRecruiting
- Mercy Cancer Center - Elk GroveRecruiting
- Bay Area Breast Surgeons IncRecruiting
- Epic Care Partners in Cancer CareRecruiting
- Contra Costa Regional Medical CenterRecruiting
- Bay Area Tumor InstituteRecruiting
- Mercy Cancer Center - RocklinRecruiting
- Mercy Cancer Center - SacramentoRecruiting
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Mission Hope Medical Oncology - Santa MariaRecruiting
- Epic Care Cyberknife Center
- Woodland Memorial HospitalRecruiting
- Rocky Mountain Regional VA Medical CenterRecruiting
- Penrose-Saint Francis HealthcareRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- Saint Francis Cancer CenterRecruiting
- Porter Adventist HospitalRecruiting
- Mercy Medical CenterRecruiting
- Southwest Oncology PCRecruiting
- Saint Anthony HospitalRecruiting
- Littleton Adventist HospitalRecruiting
- Longmont United HospitalRecruiting
- Parker Adventist HospitalRecruiting
- Saint Mary Corwin Medical CenterRecruiting
- UM Sylvester Comprehensive Cancer Center at AventuraRecruiting
- UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- UM Sylvester Comprehensive Cancer Center at KendallRecruiting
- UM Sylvester Comprehensive Cancer Center at PlantationRecruiting
- Saint Anthony's HealthRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of CarbondaleRecruiting
- SIH Cancer InstituteRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Saint Mary's HospitalRecruiting
- Northwestern UniversityRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Illinois CancerCare-DixonRecruiting
- Crossroads Cancer CenterRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Northwestern Medicine Lake Forest HospitalRecruiting
- Illinois CancerCare-MacombRecruiting
- Good Samaritan Regional Health CenterRecruiting
- UC Comprehensive Cancer Center at Silver CrossRecruiting
- Cancer Care Center of O'FallonRecruiting
- University of Chicago Medicine-Orland ParkRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment CenterRecruiting
- Illinois CancerCare-PeoriaRecruiting
- OSF Saint Francis Radiation Oncology at Peoria Cancer CenterRecruiting
- Methodist Medical Center of IllinoisRecruiting
- OSF Saint Francis Medical CenterRecruiting
- Illinois CancerCare-PeruRecruiting
- Valley Radiation OncologyRecruiting
- Illinois CancerCare-PrincetonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Reid HealthRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic PC - AmesRecruiting
- McFarland Clinic PC-BooneRecruiting
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy HospitalRecruiting
- Greater Regional Medical Center
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- McFarland Clinic PC-Trinity Cancer CenterRecruiting
- McFarland Clinic PC-JeffersonRecruiting
- McFarland Clinic PC-MarshalltownRecruiting
- Mercy Medical Center-West Lakes
- Central Care Cancer Center - Garden CityRecruiting
- Central Care Cancer Center - Great BendRecruiting
- Flaget Memorial HospitalRecruiting
- Commonwealth Cancer Center-CorbinRecruiting
- Saint Joseph HospitalRecruiting
- Saint Joseph Radiation Oncology Resource CenterRecruiting
- Saint Joseph Hospital EastRecruiting
- Saint Joseph LondonRecruiting
- Saint Joseph Mount SterlingRecruiting
- Dana-Farber Cancer InstituteRecruiting
- UMass Memorial Medical Center - University CampusRecruiting
- Hickman Cancer CenterRecruiting
- Saint Joseph Mercy HospitalRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Caro Cancer CenterRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Hematology Oncology Consultants-ClarkstonRecruiting
- Newland Medical Associates-ClarkstonRecruiting
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
- Genesee Cancer and Blood Disease Treatment CenterRecruiting
- Genesee Hematology Oncology PCRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- Academic Hematology Oncology SpecialistsRecruiting
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe WoodsRecruiting
- Sparrow HospitalRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb TownshipRecruiting
- Saint Mary's Oncology/Hematology Associates of MarletteRecruiting
- Toledo Clinic Cancer Centers-MonroeRecruiting
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer CenterRecruiting
- Newland Medical Associates-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Bhadresh Nayak MD PC-Sterling HeightsRecruiting
- Ascension Saint Joseph HospitalRecruiting
- Advanced Breast Care Center PLLCRecruiting
- Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
- Macomb Hematology Oncology PCRecruiting
- Michigan Breast Specialists-WarrenRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- Huron Gastroenterology PCRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Fairview Ridges HospitalRecruiting
- Minnesota Oncology - BurnsvilleRecruiting
- Cambridge Medical CenterRecruiting
- Mercy HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Unity HospitalRecruiting
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners IncRecruiting
- Monticello Cancer CenterRecruiting
- New Ulm Medical CenterRecruiting
- Fairview Northland Medical CenterRecruiting
- North Memorial Medical Health CenterRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Sanford Thief River Falls Medical CenterRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Sanford Cancer Center WorthingtonRecruiting
- Fairview Lakes Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-BallwinRecruiting
- Central Care Cancer Center - BolivarRecruiting
- Cox Cancer Center BransonRecruiting
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- Siteman Cancer Center at West County HospitalRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest CampusRecruiting
- Freeman Health SystemRecruiting
- Mercy Hospital JoplinRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-South CityRecruiting
- Washington University School of MedicineRecruiting
- Mercy Hospital SouthRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Missouri Baptist Medical CenterRecruiting
- Siteman Cancer Center at Christian HospitalRecruiting
- Mercy Hospital Saint LouisRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Mercy Hospital WashingtonRecruiting
- CHI Health Saint Francis
- CHI Health Good SamaritanRecruiting
- Saint Elizabeth Regional Medical CenterRecruiting
- Alegent Health Immanuel Medical CenterRecruiting
- Alegent Health Bergan Mercy Medical CenterRecruiting
- Alegent Health Lakeside HospitalRecruiting
- Creighton University Medical CenterRecruiting
- Midlands Community HospitalRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Monmouth Medical Center Southern CampusRecruiting
- Saint Barnabas Medical CenterRecruiting
- Monmouth Medical CenterRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Community Medical CenterRecruiting
- Memorial Sloan Kettering CommackRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Garnet Health Medical CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Margaret R Pardee Memorial HospitalRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford South University Medical CenterRecruiting
- Southpointe-Sanford Medical Center FargoRecruiting
- Sanford Medical Center FargoRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Saint Elizabeth Boardman HospitalRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital SouthRecruiting
- Good Samaritan Hospital - CincinnatiRecruiting
- Oncology Hematology Care Inc-KenwoodRecruiting
- Bethesda North HospitalRecruiting
- TriHealth Cancer Institute-WestsideRecruiting
- TriHealth Cancer Institute-AndersonRecruiting
- Dayton Blood and Cancer CenterRecruiting
- Miami Valley HospitalRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital NorthRecruiting
- Armes Family Cancer CenterRecruiting
- Blanchard Valley HospitalRecruiting
- Orion Cancer CareRecruiting
- Atrium Medical Center-Middletown Regional HospitalRecruiting
- Dayton Physicians LLC-AtriumRecruiting
- Dayton Physicians LLC-WayneRecruiting
- Wayne HospitalRecruiting
- Greater Dayton Cancer CenterRecruiting
- Kettering Medical CenterRecruiting
- Toledo Clinic Cancer Centers-MaumeeRecruiting
- Toledo Clinic Cancer Centers-ToledoRecruiting
- Dayton Physicians LLC - TroyRecruiting
- Upper Valley Medical CenterRecruiting
- Saint Joseph Warren HospitalRecruiting
- Saint Elizabeth Youngstown HospitalRecruiting
- Cancer Centers of Southwest Oklahoma ResearchRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Pocono Medical CenterRecruiting
- Lehigh Valley Hospital-HazletonRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Saint Joseph Regional Cancer Center
- Sovah Health Martinsville
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Saint Elizabeth Hospital
- Saint Francis Hospital
- Saint Clare Hospital
- Franciscan Research Center-Northwest Medical Plaza
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Froedtert Menomonee Falls HospitalRecruiting
- Medical College of WisconsinRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- Drexel Town Square Health CenterRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Froedtert West Bend Hospital/Kraemer Cancer CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
Arms of the Study
Arm 1
Experimental
Treatment (discontinue hormonal medication, follow up)
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 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.