Prostate Cancer Clinical Trial
A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Prostate-Specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Positive Hormone-Sensitive Prostate Cancer Participants
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.
Full Description
Prostate cancer is currently the fifth leading cause of cancer deaths among men globally, with 1 million diagnosed per year and mortality burden of over 300,000 deaths. The hypothesis of study is addition of apalutamide to RT+ LHRHa provides superior efficacy in terms of PSMA-PET metastatic progression-free survival-ppMPFS. Apalutamide is a non-steroidal androgen receptor (AR) antagonist being developed for the treatment of prostate cancer. RT+LHRHa is a combination therapy, when administered concomitantly, in high-risk patients with BCR relapsing after RP, potentially leads to relevant delay in the metastatic progression of prostate cancer at an early stage of the disease, or even cure in some cases. Study consists of 2 cohorts (intervention and observational cohort). At screening, eligible participants will undergo prostate-specific membrane antigen-positron emission tomography (PSMA-PET), whole-body Tc-bone scan, computed tomography (CT). Interventional Cohort, consisting of PSMA-PET positive participants, will undergoes 3 phases: Treatment Phase, a Post-treatment Phase and a Post-PSMA-PET Progression Phase. After 6-month Treatment Phase, participants will be prospectively assessed in Post-treatment Phase until PSMA-PET-positive metastatic progression is confirmed. Observational cohort will run parallelly to interventional cohort. PSMA-PET negative, participants will be observed until time-point when number of events required for analysis of primary endpoint is reached in Interventional Cohort. This cohort provides an approach to document the selection of treatments and observation of interventions in a real-life clinical practice setting. The duration of the study is estimated to be approximately 7 years.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate
Previously treated with radical prostatectomy with or without lymph node dissection and any post-operative prostate-specific antigen (PSA) measurement of less than (<) 0.1 nanogram/milliliter (ng/mL) between Week 6 and Week 20
Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce
Prostate specific membrane antigen-positron emission tomography (PSMA-PET) must be performed at screening: Patients who are PSMA-PET-positive for at least one loco-regional (pelvic) lesion with or without distant (extra-pelvic) lesions at screening, as determined by Blinded Independent Central Review (BICR), will be eligible to be randomized to either arm of the Interventional Cohort.The investigators will be blinded to the location of the PSMA-PET lesions after randomization and patients who are PSMA-PET-negative for any prostate cancer lesions (that is no loco-regional lesion and no distant lesion) at screening, as determined by BICR, will be eligible for inclusion in the Observational Cohort
Biochemically recurrent prostate cancer after RP with a high risk of developing metastasis defined as pathological Gleason score greater than or equal to (>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, OR PSADT less than or equal to (<=) 12 months at the time of screening
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 patient should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be sent to BICR for confirmation of non-metastatic prostate cancer 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) prostate cancer (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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 145 Locations for this study
Tucson Arizona, 85741, United States
Little Rock Arkansas, 72211, 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
Bedford Park , 5042, Australia
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
Innsbruck , 6020, Austria
Linz , 4020, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Brugge , 8000, Belgium
Gent , 9000, Belgium
Kortrijk , 8500, Belgium
Wilrijk , 2610, Belgium
Belo Horizonte , 30110, Brazil
Curitiba , 81520, Brazil
Natal , 59075, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90050, Brazil
Rio de Janeiro , 22250, Brazil
Salvador , 41253, Brazil
Sao Paulo , 01421, Brazil
Sao Paulo , 04014, Brazil
São Paulo , 01308, Brazil
São Paulo , 05652, 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
Helsinki , 00290, Finland
Oulu , 90220, Finland
Tampere , 33521, Finland
Turku , 20520, Finland
Vaasa , 65130, Finland
Berlin , 10967, Germany
Braunschweig , 38126, Germany
Dresden , 01307, Germany
Essen , D-451, Germany
Muenster , 48149, Germany
Munchen , 81675, Germany
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
Porto , 42000, Portugal
Santa Maria da Feira , 4520-, Portugal
Ekaterinburg , 62010, Russian Federation
Ivanovo , 15304, Russian Federation
Moscow , 10507, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 11799, Russian Federation
Moscow , 11999, Russian Federation
Moscow , 12135, Russian Federation
Moscow , 12528, Russian Federation
Nizhni Novgorod , 60310, Russian Federation
Omsk , 64401, Russian Federation
Pyatigorsk , 35750, Russian Federation
Saint Petersburg , 19660, Russian Federation
Saint Petersburg , 19702, Russian Federation
Saint-Petersburg , 19110, Russian Federation
Saint-Petersburg , 19506, Russian Federation
Sankt-Peterburg , 19775, Russian Federation
Tyumen , 62504, Russian Federation
Banska Bystrica , 974 0, Slovakia
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
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 , 34010, Turkey
Istanbul , 34096, Turkey
Istanbul , 34147, Turkey
Istanbul , 34722, Turkey
Istanbul , 34890, Turkey
Izmir , 35340, Turkey
Sakarya , 54187, Turkey
How clear is this clinincal trial information?