Prostate Cancer Clinical Trial
A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer
Summary
The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate
Previously treated with radical prostatectomy with or without lymph node dissection and either: a) for biochemical recurrence after radical prostatectomy (RP): any post-operative prostate-specific antigen (PSA) measurement of less than (<) 0.1 nanogram/milliliter (ng/mL) within 12 months after RP and without any PSA greater than and equal to (>=) 0.1 ng/mL within the 4 to 8-week period after RP or b) for persistent PSA after RP: PSA >=0.1 ng/mL within the 4 to 8-week period after RP, confirmed by additional measurement at least 3 weeks later
Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce
Results of the Prostate specific membrane antigen-positron emission tomography (PSMA-PET) at screening as determined by blinded independent, central review (BICR), must be: PSMA-PET-negative for any prostate cancer lesions (that is, no loco-regional lesion and no distant lesions); or PSMA-PET-positive for at least one loco-regional (pelvic) lesion without distant extra-pelvic lesion; or PSMA PET- positive for at least one loco--regional (pelvic) lesion with extra-pelvic lesion(s).
High risk of developing metastasis defined as; a) for biochemical recurrence after RP: pathological Gleason score greater than or equal to (>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, or prostate-specific antigen doubling time (PSADT) less than or equal to (<=) 12 months at the time of screening; b) for persistent PSA after RP: pathological Gleason score >=8, evaluated from prostate tissue specimen at radical prostatectomy
Participants with evidence of distant metastasis on screening PSMA-PET scan must have no evidence of prostate cancer metastases on screening CT/MRI of the chest/abdomen/pelvis, Technetium 99m [99mTc] whole-body bone scan. Participants with a single bone lesion on 99mTc whole-body bone scan should have confirmatory imaging by CT or MRI; if the confirmatory scan confirms the bone lesion, the participant should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be evaluated locally before randomization
Eastern Cooperative Oncology Group Performance Status Grade 0 or 1
Exclusion Criteria:
History of pelvic radiation for malignancy
Previous treatment with androgen deprivation therapy (ADT) for prostate cancer
Previously treated for biochemical recurrence (BCR) or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed)
Prior treatment with a CYP17 inhibitor (example, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any androgen receptor (AR) antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy
Known or suspected contraindications or hypersensitivity to apalutamide, Luteinizing Hormone-Releasing Hormone (LHRH) agonist or any of the components of the formulations
Prior chemotherapy for prostate cancer
Any evidence of prostate cancer metastasis on computed tomography/magnetic resonance imaging (CT/MRI) of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening
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There are 119 Locations for this study
Tucson Arizona, 85741, United States
Lakewood Colorado, 80228, United States
Hialeah Florida, 33016, United States
Jeffersonville Indiana, 47130, United States
Troy Michigan, 48084, United States
Syracuse New York, 13210, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Houston Texas, 77027, United States
Spokane Washington, 99202, United States
Bundaberg , 4670, Australia
Bundaberg , 4670, Australia
East Melbourne , 3002, Australia
Fitzroy , 3065, Australia
Hurstville , 2220, Australia
North Ryde , 2109, Australia
Waratah , 2298, Australia
Wembley , 6014, Australia
Linz , 4020, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Brugge , 8000, Belgium
Gent , 9000, Belgium
Kortrijk , 8500, Belgium
Wilrijk , 2610, Belgium
Curitiba , 81520, Brazil
Natal , 59075, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90050, Brazil
Salvador , 41253, Brazil
Sao Paulo , 01421, Brazil
Sao Paulo , 04014, Brazil
São Paulo , 01308, Brazil
Plzen , 305 9, Czechia
Praha 2 , 120 0, Czechia
Praha 2 , 120 0, Czechia
Praha 5 , 15006, Czechia
Aalborg , 9000, Denmark
Aarhus N. , 8200, Denmark
Copenhagen N , 2200, Denmark
Herlev , 2730, Denmark
Oulu , 90220, Finland
Tampere , 33521, Finland
Turku , 20520, Finland
Vaasa , 65130, Finland
Budapest , 1076, Hungary
Budapest , 1106, Hungary
Budapest , 1122, Hungary
Budapest , 1125, Hungary
Budapest , 1145, Hungary
Budapest , 1204, Hungary
Debrecen , 4032, Hungary
Bologna , 40138, Italy
Firenze , 50134, Italy
Milano , 20132, Italy
Roma , 00133, Italy
Roma , 00144, Italy
Roma , 00189, Italy
Amman , 0000, Jordan
Beirut , 11 00, Lebanon
Beirut , 1107 , Lebanon
Jbeil , 3, Lebanon
Zgharta , 100, Lebanon
Durango , 34000, Mexico
Leon , 37000, Mexico
Monterrey , 64710, Mexico
Naucalpan , 53100, Mexico
Oaxaca de Juárez , 68020, Mexico
Puebla , 72530, Mexico
Queretaro , 76000, Mexico
Bydgoszcz , 85-79, Poland
Elblag , 82-30, Poland
Gdansk , 80-95, Poland
Gdynia , 81-51, Poland
Kielce , 25-73, Poland
Lodz , 93-51, Poland
Radom , 26-60, Poland
Warszawa , 02-78, Poland
Lisboa , 1099-, Portugal
Lisboa , 1350-, Portugal
Lisboa , 1400-, Portugal
Lisboa , 1449-, Portugal
Lisboa , 1500-, Portugal
Lisboa , 1649-, Portugal
Porto , 4099-, Portugal
Santa Maria da Feira , 4520-, Portugal
Ekaterinburg , 62010, Russian Federation
Ivanovo , 15304, Russian Federation
Moscow , 10507, Russian Federation
Moscow , 11999, Russian Federation
Moscow , 12528, Russian Federation
Saint Petersburg , 19702, Russian Federation
Tyumen , 62504, Russian Federation
Bratislava , 851 0, Slovakia
Košice , 04191, Slovakia
Martin , 036 5, Slovakia
Nitra , 94901, Slovakia
Poprad , 05801, Slovakia
Prešov , 08001, Slovakia
Trencin , 911 0, Slovakia
Cadiz , 11009, Spain
Ferrol , 15405, Spain
Jerez de la Frontera , 11407, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Málaga , 29010, Spain
Navarra , 31008, Spain
Pamplona , 31008, Spain
Sevilla , 41013, Spain
Zaragoza , 50009, Spain
Malmö , 205 0, Sweden
Stockholm , 112 1, Sweden
Stockholm , 11883, Sweden
Adana , 01250, Turkey
Ankara , 06230, Turkey
Ankara , 06520, Turkey
Ankara , 06590, Turkey
Ankara , 6200, Turkey
Istanbul , 34096, Turkey
Istanbul , 34147, Turkey
Istanbul , 34722, Turkey
Istanbul , 34890, Turkey
Izmir , 35340, Turkey
Sakarya , 54187, Turkey
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