A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC (LIB

A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC (LIBERTAS)

Last Updated May 14, 2025

Want to learn how to participate in this trial?

CR109327

OVERVIEW

Age
18+ years
Phase
phase 3
Sites
91 Sites
Status

Recruiting

SUMMARY

The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level < 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.

CONDITIONS

Metastatic Castrate-sensitive Prostate Cancer

ELIGIBILITY

Inclusion Criteria:

* Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
* For participants not undergoing Gender-affirming care: Metastatic prostate cancer disease documented by conventional imaging (example, computed tomography [CT], magnetic resonance imaging [MRI], or bone scan) and/or next-generation imaging [NGI] demonstrating greater than equal (>=) 2 distinct extraprostatic sites of metastasis
* For participants undergoing Gender-affirming care: No evidence of metastasis by either conventional imaging (example, CT, MRI, or bone scan) and/or NGI is also acceptable
* For participants not undergoing gender-affirming care: testosterone levels > 50 (ng/dL) nanograms per deciliter at screening, except for those who may have received ADT prior to screening. Participants are allowed to have received up to 3 months of (ADT) androgen-deprivation therapy prior to enrollment
* For participants undergoing Gender-affirming care: There is no testosterone level requirement for inclusion
* Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy
* A participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of study treatment
* Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)
* Assigned male at birth, inclusive of all gender identities

Exclusion Criteria:

* History of seizure or known condition that has been determined to significantly predispose to seizure per investigator
* Pelvic lymph nodes as only site of metastasis
* Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
* Any of the following within 6 months prior to screening: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events
* Gastrointestinal disorder affecting absorption
* Participants who have undergone a bilateral orchiectomy with the exception of participants who completed this as part of their gender-affirming care or a result of a variation in physical sex development

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Germany, Brazil, China, France, Australia, Canada, Mexico, Poland

Country (9)	City or Province (91)	Status
United States	Basking Ridge MSKCC Basking Ridge	RECRUITING
United States	Middletown MSKCC Monmouth	RECRUITING
United States	Montvale MSKCC Bergen	RECRUITING
United States	Commack MSKCC Commack	RECRUITING
United States	Harrison MSKCC Westchester	RECRUITING
United States	New York Columbia University Medical Center	RECRUITING
United States	New York Memorial Sloan Kettering Cancer Center	RECRUITING
United States	Uniondale MSKCC Nassau Regional Cancer Center	RECRUITING
United States	Dallas Parkland Health and Hospital System	RECRUITING
Germany	Lubeck Universitatsklinikum Schleswig Holstein Campus Lubeck	RECRUITING
Brazil	Natal Liga Norte Riograndense Contra O Cancer	RECRUITING
China	Beijing Peking University First Hospital	COMPLETED
United States	Fresno Urology Associates of Central California	RECRUITING
United States	San Francisco VA Medical Center	RECRUITING
United States	Santa Barbara Sansum Clinic Pharm	COMPLETED
United States	Middleburg Heights Helios Clinical Research, LLC	COMPLETED
United States	Pittsburgh VA Pittsburgh	COMPLETED
United States	Germantown The Conrad Pearson Clinic	COMPLETED
United States	Dallas Texas Oncology P A	COMPLETED
United States	Norfolk Virginia Oncology Associates	COMPLETED
France	Paris Hopital Cochin	COMPLETED
United States	Homewood Urology Centers Of Alabama	ACTIVE_NOT_RECRUITING
United States	Tucson Arizona Urology Specialists	ACTIVE_NOT_RECRUITING
United States	Little Rock Arkansas Urology	ACTIVE_NOT_RECRUITING
United States	Lakewood Colorado Clinical Research	ACTIVE_NOT_RECRUITING
United States	Daytona Beach Advanced Urology Institute	ACTIVE_NOT_RECRUITING
United States	Chicago Ridge Associated Urological Specialists LLC	ACTIVE_NOT_RECRUITING
United States	Joliet Advanced Urology Associates	COMPLETED
United States	Greenwood Urology of Indiana	ACTIVE_NOT_RECRUITING
United States	Jeffersonville First Urology, PSC	ACTIVE_NOT_RECRUITING
United States	Silver Spring Maryland Oncology Hematology P A	ACTIVE_NOT_RECRUITING
United States	Towson Chesapeake Urology Research Associates	ACTIVE_NOT_RECRUITING
United States	Troy Michigan Institute of Urology	ACTIVE_NOT_RECRUITING
United States	Syracuse Associated Medical Professionals	ACTIVE_NOT_RECRUITING
United States	Cincinnati TriState Urologic Services PSC Inc. DBA The Urology Group	ACTIVE_NOT_RECRUITING
United States	Gahanna Central Ohio Urology Group	COMPLETED
United States	Tigard Northwest Cancer Specialists PC	ACTIVE_NOT_RECRUITING
United States	Bala-Cynwyd Centers for Advanced Urology LLC d b a MidLantic Urology	ACTIVE_NOT_RECRUITING
United States	Pittsburgh University of Pittsburgh Medical Center	COMPLETED
United States	Nashville Urology Associates	ACTIVE_NOT_RECRUITING
United States	Austin Texas Oncology P A	ACTIVE_NOT_RECRUITING
United States	Dallas UT Southwestern Medical Center	ACTIVE_NOT_RECRUITING
United States	Houston Texas Oncology P A	ACTIVE_NOT_RECRUITING
United States	Houston Houston Metro Urology	ACTIVE_NOT_RECRUITING
United States	San Antonio Texas Oncology San Antonio Northeast	ACTIVE_NOT_RECRUITING
United States	Wichita Falls Texas Oncology P A	ACTIVE_NOT_RECRUITING
United States	Salt Lake City University of Utah Huntsman Cancer Institute	ACTIVE_NOT_RECRUITING
United States	Roanoke Oncology and Hematology Associates of Southwest Virginia, Inc.	ACTIVE_NOT_RECRUITING
United States	Virginia Beach Urology Of Virginia, Pllc	ACTIVE_NOT_RECRUITING
	Macquarie University Macquarie University Hospital	ACTIVE_NOT_RECRUITING
Australia	Melbourne Peter MacCallum Cancer Centre	ACTIVE_NOT_RECRUITING
Australia	South Brisbane Mater Misericordiae Hospital	ACTIVE_NOT_RECRUITING
Brazil	Barretos Fundacao Pio XII	ACTIVE_NOT_RECRUITING
Brazil	Belo Horizonte Hospital das Clínicas - Universidade Federal de Minas Gerais	ACTIVE_NOT_RECRUITING
Brazil	Rio de Janeiro Ministerio da Saude Instituto Nacional do Cancer	ACTIVE_NOT_RECRUITING
Brazil	Salvador Instituto D Or de Pesquisa e Ensino	ACTIVE_NOT_RECRUITING
Brazil	Santo André CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia	ACTIVE_NOT_RECRUITING
Brazil	Sao Paulo Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo	ACTIVE_NOT_RECRUITING
Canada	Calgary Southern Alberta Institute of Urology / Prostate Cancer Centre	ACTIVE_NOT_RECRUITING
Canada	Halifax Nova Scotia Health Authority	ACTIVE_NOT_RECRUITING
Canada	Toronto Sunnybrook Health Sciences Center	ACTIVE_NOT_RECRUITING
Canada	Toronto Princess Margaret Hospital	ACTIVE_NOT_RECRUITING
Canada	Quebec CHU de Quebec Universite Laval Hopital de l Enfant Jesus	ACTIVE_NOT_RECRUITING
China	Changchun The First Hospital of Jilin University	ACTIVE_NOT_RECRUITING
China	Chengdu West China School of Medicine/West China Hospital, Sichuan University	ACTIVE_NOT_RECRUITING
China	Guangzhou Nanfang Hospital of Southern Medical Hospital	ACTIVE_NOT_RECRUITING
China	Jinan Shandong Provincial Hospital	ACTIVE_NOT_RECRUITING
China	Ningbo Ningbo First Hospital	ACTIVE_NOT_RECRUITING
China	Shenyang Shengjing Hospital Of China Medical University	ACTIVE_NOT_RECRUITING
China	Wuhan TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology	ACTIVE_NOT_RECRUITING
China	XI An The First Affiliated Hospital of Xian Jiaotong University	ACTIVE_NOT_RECRUITING
France	Bordeaux Institut Bergonie	ACTIVE_NOT_RECRUITING
France	Lyon Centre Leon Berard	ACTIVE_NOT_RECRUITING
France	Rennes Chu Rennes Hopital Pontchaillou	COMPLETED
France	Villejuif Cedex Gustave Roussy	ACTIVE_NOT_RECRUITING
Germany	Aachen Universitaetsklinikum der RWTH Aachen	ACTIVE_NOT_RECRUITING
Germany	Augsburg Klinikum Augsburg	ACTIVE_NOT_RECRUITING
Germany	Dresden Universitaetsklinikum Carl Gustav Carus TU Dresden	ACTIVE_NOT_RECRUITING
Germany	Koeln Universitaetsklinikum Koelnt	ACTIVE_NOT_RECRUITING
Germany	Muenchen Klinikum rechts der Isar - der Technischen Universität München	ACTIVE_NOT_RECRUITING
Germany	Nuertingen Studienpraxis Urologie Nurtingen	ACTIVE_NOT_RECRUITING
Germany	Würzburg Universitatsklinikum Wurzburg	ACTIVE_NOT_RECRUITING
Mexico	Chihuahua SCIENTIA Investigacion Clinica SC	ACTIVE_NOT_RECRUITING
Mexico	Durango Consultorio de Especialidad en Urologia Privado	ACTIVE_NOT_RECRUITING
Mexico	Merida Medical Care & Research SA de CV	ACTIVE_NOT_RECRUITING
Mexico	Queretaro Cuidados Oncologicos	ACTIVE_NOT_RECRUITING
Poland	Bydgoszcz Centrum Onkologii im Prof F Lukaszczyka	ACTIVE_NOT_RECRUITING
Poland	Koszalin Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie	ACTIVE_NOT_RECRUITING
Poland	Warszawa Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy	ACTIVE_NOT_RECRUITING
Poland	Warszawa Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O	ACTIVE_NOT_RECRUITING
Poland	Wroclaw Polimed Specjalistyczna Przychodnia Lekarska Wieslaw Grazyna Tupikowski Bednarek Tupikowska S C	ACTIVE_NOT_RECRUITING

Geo Locations

40.70621, -74.54932

40.39652, -74.09211

41.04676, -74.02292

40.84288, -73.29289

40.96899, -73.71263

40.71427, -74.00597

40.70038, -73.59291

32.78306, -96.80667

53.86893, 10.68729

-5.795, -35.20944

39.9075, 116.39723

36.74773, -119.77237

37.77493, -122.41942

34.42083, -119.69819

41.36144, -81.81291

40.44062, -79.99589

35.08676, -89.81009

32.78306, -96.80667

36.84681, -76.28522

48.85341, 2.3488

33.47177, -86.80082

32.22174, -110.92648

34.74648, -92.28959

39.70471, -105.08137

29.21081, -81.02283

41.70142, -87.77922

41.52519, -88.0834

39.61366, -86.10665

38.27757, -85.73718

38.99067, -77.02609

39.4015, -76.60191

42.60559, -83.14993

43.04812, -76.14742

39.12713, -84.51435

40.01923, -82.87934

45.43123, -122.77149

40.00761, -75.23407

40.44062, -79.99589

36.16589, -86.78444

30.26715, -97.74306

32.78306, -96.80667

29.76328, -95.36327

29.42412, -98.49363

33.91371, -98.49339

40.76078, -111.89105

37.27097, -79.94143

36.85293, -75.97799

-25.274398, 133.775136

-37.814, 144.96332

-27.48034, 153.02049

-20.55722, -48.56778

-19.92083, -43.93778

-22.90278, -43.2075

-12.97111, -38.51083

-23.66389, -46.53833

-23.5475, -46.63611

51.05011, -114.08529

44.64533, -63.57239

43.70011, -79.4163

46.81228, -71.21454

43.88, 125.32278

30.66667, 104.06667

23.11667, 113.25

36.66833, 116.99722

29.87819, 121.54945

41.79222, 123.43278

30.58333, 114.26667

34.2112799, 108.99608

44.84044, -0.5805

45.74848, 4.84669

48.11198, -1.67429

48.7939, 2.35992

50.77664, 6.08342

48.37154, 10.89851

51.05089, 13.73832

50.93333, 6.95

51.60698, 13.31243

48.6134025, 9.3213278

49.79391, 9.95121

28.63528, -106.08889

24.02032, -104.65756

20.97537, -89.61696

20.591681, -100.39752

53.1235, 18.00762

54.19438, 16.17222

52.22977, 21.01178

51.1, 17.03333

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

OVERVIEW

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

40.70621, -74.54932

40.39652, -74.09211

41.04676, -74.02292

40.84288, -73.29289

40.96899, -73.71263

40.71427, -74.00597

40.71427, -74.00597

40.70038, -73.59291

32.78306, -96.80667

53.86893, 10.68729

-5.795, -35.20944

39.9075, 116.39723

36.74773, -119.77237

37.77493, -122.41942

34.42083, -119.69819

41.36144, -81.81291

40.44062, -79.99589

35.08676, -89.81009

32.78306, -96.80667

36.84681, -76.28522

48.85341, 2.3488

33.47177, -86.80082

32.22174, -110.92648

34.74648, -92.28959

39.70471, -105.08137

29.21081, -81.02283

41.70142, -87.77922

41.52519, -88.0834

39.61366, -86.10665

38.27757, -85.73718

38.99067, -77.02609

39.4015, -76.60191

42.60559, -83.14993

43.04812, -76.14742

39.12713, -84.51435

40.01923, -82.87934

45.43123, -122.77149

40.00761, -75.23407

40.44062, -79.99589

36.16589, -86.78444

30.26715, -97.74306

32.78306, -96.80667

29.76328, -95.36327

29.76328, -95.36327

29.42412, -98.49363

33.91371, -98.49339

40.76078, -111.89105

37.27097, -79.94143

36.85293, -75.97799

-25.274398, 133.775136

-37.814, 144.96332

-27.48034, 153.02049

-20.55722, -48.56778

-19.92083, -43.93778

-22.90278, -43.2075

-12.97111, -38.51083

-23.66389, -46.53833

-23.5475, -46.63611

51.05011, -114.08529

44.64533, -63.57239

43.70011, -79.4163

43.70011, -79.4163

46.81228, -71.21454

43.88, 125.32278

30.66667, 104.06667

23.11667, 113.25

36.66833, 116.99722

29.87819, 121.54945

41.79222, 123.43278

30.58333, 114.26667