JOURNAL ONKOLOGIE – STUDIE
PRIMORDIUM 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
Rekrutierend
NCT-Nummer:
NCT04557059
Studienbeginn:
November 2020
Letztes Update:
28.12.2020
Wirkstoff:
LHRHa, Apalutamide
Indikation (Clinical Trials):
Prostatic Neoplasms
Geschlecht:
Männer
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 3
Sponsor:
Janssen-Cilag Ltd.
Collaborator:
-
Studienleiter
Study Director
Janssen-Cilag Ltd.
Kontakt
Kontakt:
Phone: 844-434-4210
E-Mail: JNJ.CT@sylogent.com» Kontaktdaten anzeigen
Studienlocations (3 von 74)
Universitatsklinikum Carl Gustav Carcus Dresden
01307 Dresden
(Sachsen)
GermanyNoch nicht rekrutierend» Google-MapsUniversitatsklinikum Essen
D-45147 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-MapsUniversitaetsklinikum Muenster
48149 Muenster
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
01307 Dresden
(Sachsen)
GermanyNoch nicht rekrutierend» Google-MapsUniversitatsklinikum Essen
D-45147 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-MapsUniversitaetsklinikum Muenster
48149 Muenster
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Flinders Medical Centre
5042 Bedford Park
AustraliaNoch nicht rekrutierend» Google-MapsBundaberg Hospital
4670 Bundaberg
AustraliaNoch nicht rekrutierend» Google-MapsSaint Vincent's Hospital - Melbourne
3065 Fitzroy
AustraliaNoch nicht rekrutierend» Google-MapsGenesis Care Hurstville
2220 Hurstville
AustraliaNoch nicht rekrutierend» Google-MapsMacquarie University Hospital
2109 North Ryde
AustraliaNoch nicht rekrutierend» Google-MapsEpworth Healthcare
3121 Richmond
AustraliaNoch nicht rekrutierend» Google-MapsBundaberg Hospital
4655 Urraween
AustraliaNoch nicht rekrutierend» Google-MapsCalvary Mater Newcastle
2298 Waratah
AustraliaNoch nicht rekrutierend» Google-MapsGenesisCare Wembley
6014 Wembley
AustraliaNoch nicht rekrutierend» Google-MapsMedical University Innsbruck
6020 Innsbruck
AustriaZurückgezogen» Google-MapsOrdensklinikum Linz GmbH Elisabethinen
4020 Linz
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5020 Salzburg
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1090 Wien
AustriaNoch nicht rekrutierend» Google-MapsA.Z. Sint Jan
8000 Brugge
BelgiumNoch nicht rekrutierend» Google-MapsUZ Gent
9000 Gent
BelgiumNoch nicht rekrutierend» Google-MapsAz Groeninge
8500 Kortrijk
BelgiumNoch nicht rekrutierend» Google-MapsGZA Ziekenhuis
2610 Wilrijk
BelgiumNoch nicht rekrutierend» Google-MapsFakultni nemocnice Plzen, Urologicka klinika
305 99 Plzen
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120 00 Praha 2
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9000 Aalborg
DenmarkNoch nicht rekrutierend» Google-MapsAarhus University Hospital
8200 Aarhus N.
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2200 Copenhagen N
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2730 Herlev
DenmarkNoch nicht rekrutierend» Google-MapsCentre Hospitalier du Nord
100 Beirut
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11 00 2807 Beirut
LebanonNoch nicht rekrutierend» Google-MapsAmerican Universitty of Beirut Medical Center
1107 2020 Beirut
LebanonNoch nicht rekrutierend» Google-MapsNotre Dame De Secours
3 Jbeil
LebanonNoch nicht rekrutierend» Google-MapsCentrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
85-796 Bydgoszcz
PolandRekrutierend» Google-MapsUniwersyteckie Centrum Kliniczne
80-952 Gdansk
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81-519 Gdynia
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25-734 Kielce
PolandNoch nicht rekrutierend» Google-MapsWojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
93-411 Lodz
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26-600 Radom
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02-781 Warszawa
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1099-023 Lisboa
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1400-038 Lisboa
PortugalNoch nicht rekrutierend» Google-MapsChln - Hosp. Santa Maria
1649-035 Lisboa
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4099-001 Porto
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4200072 Porto
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620102 Ekaterinburg
Russian FederationNoch nicht rekrutierend» Google-MapsIvanovo Regional Oncology Dispensary
153040 Ivanovo
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105077 Moscow
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115478 Moscow
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117997 Moscow
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119991 Moscow
Russian FederationNoch nicht rekrutierend» Google-MapsCentral Clinical Hospital
121359 Moscow
Russian FederationNoch nicht rekrutierend» Google-MapsHertzen Oncology Research Institute
125284 Moscow
Russian FederationNoch nicht rekrutierend» Google-MapsPrivolzhsky District Medical Center under the Federal Medico-Biological Agency
603109 Nizhni Novgorod
Russian FederationNoch nicht rekrutierend» Google-MapsClinical Oncology Dispensary
644013 Omsk
Russian FederationNoch nicht rekrutierend» Google-MapsLLC Novaya Clinica
357500 Pyatigorsk
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196603 Saint Petersburg
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197022 Saint Petersburg
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195067 Saint-Petersburg
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197758 Saint-Petersburg
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625041 Tyumen
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29010 Málaga
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31008 Navarra
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31008 Pamplona
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50009 Zaragoza
SpainNoch nicht rekrutierend» Google-MapsHosp. Univ. Miguel Servet
50009 Zaragoza
SpainNoch nicht rekrutierend» Google-MapsUrologiska Mottagningen
205 02 Malmö
SwedenNoch nicht rekrutierend» Google-MapsSödersjukhuset
11883 Stockholm
SwedenNoch nicht rekrutierend» Google-MapsHacettepe Uni Medical Faculty Dept. of Urology
06100 Ankara
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06590 Ankara
TurkeyNoch nicht rekrutierend» Google-MapsDr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
6200 Ankara
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34096 Istanbul
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34147 Istanbul
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34722 Istanbul
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34890 Istanbul
TurkeyNoch nicht rekrutierend» Google-MapsDokuz Eylul Universitesi Tip Fakültesi Hastanesi
35340 Izmir
TurkeyNoch nicht rekrutierend» Google-MapsSakarya Üniversitesi Tıp Fakültesi Hastanesi
54187 Sakarya
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Alle anzeigen 5042 Bedford Park
AustraliaNoch nicht rekrutierend» Google-MapsBundaberg Hospital
4670 Bundaberg
AustraliaNoch nicht rekrutierend» Google-MapsSaint Vincent's Hospital - Melbourne
3065 Fitzroy
AustraliaNoch nicht rekrutierend» Google-MapsGenesis Care Hurstville
2220 Hurstville
AustraliaNoch nicht rekrutierend» Google-MapsMacquarie University Hospital
2109 North Ryde
AustraliaNoch nicht rekrutierend» Google-MapsEpworth Healthcare
3121 Richmond
AustraliaNoch nicht rekrutierend» Google-MapsBundaberg Hospital
4655 Urraween
AustraliaNoch nicht rekrutierend» Google-MapsCalvary Mater Newcastle
2298 Waratah
AustraliaNoch nicht rekrutierend» Google-MapsGenesisCare Wembley
6014 Wembley
AustraliaNoch nicht rekrutierend» Google-MapsMedical University Innsbruck
6020 Innsbruck
AustriaZurückgezogen» Google-MapsOrdensklinikum Linz GmbH Elisabethinen
4020 Linz
AustriaNoch nicht rekrutierend» Google-MapsUniversitätsklinikum Salzburg - Landeskrankenhaus
5020 Salzburg
AustriaNoch nicht rekrutierend» Google-MapsMedizinische Universität Wien
1090 Wien
AustriaNoch nicht rekrutierend» Google-MapsA.Z. Sint Jan
8000 Brugge
BelgiumNoch nicht rekrutierend» Google-MapsUZ Gent
9000 Gent
BelgiumNoch nicht rekrutierend» Google-MapsAz Groeninge
8500 Kortrijk
BelgiumNoch nicht rekrutierend» Google-MapsGZA Ziekenhuis
2610 Wilrijk
BelgiumNoch nicht rekrutierend» Google-MapsFakultni nemocnice Plzen, Urologicka klinika
305 99 Plzen
CzechiaNoch nicht rekrutierend» Google-MapsUrologicka klinika 1.LF UK a VFN
120 00 Praha 2
CzechiaNoch nicht rekrutierend» Google-MapsAalborg University Hospital
9000 Aalborg
DenmarkNoch nicht rekrutierend» Google-MapsAarhus University Hospital
8200 Aarhus N.
DenmarkRekrutierend» Google-MapsRigshospitalet
2200 Copenhagen N
DenmarkRekrutierend» Google-MapsGentofte Herlev Hospital
2730 Herlev
DenmarkNoch nicht rekrutierend» Google-MapsCentre Hospitalier du Nord
100 Beirut
LebanonNoch nicht rekrutierend» Google-MapsSt Georges Hospital university medical centre
11 00 2807 Beirut
LebanonNoch nicht rekrutierend» Google-MapsAmerican Universitty of Beirut Medical Center
1107 2020 Beirut
LebanonNoch nicht rekrutierend» Google-MapsNotre Dame De Secours
3 Jbeil
LebanonNoch nicht rekrutierend» Google-MapsCentrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
85-796 Bydgoszcz
PolandRekrutierend» Google-MapsUniwersyteckie Centrum Kliniczne
80-952 Gdansk
PolandRekrutierend» Google-MapsSzpitale Pomorskie Sp. z o.o.
81-519 Gdynia
PolandRekrutierend» Google-MapsSwietokrzyskie Centrum Onkologii SPZOZ w Kielcach
25-734 Kielce
PolandNoch nicht rekrutierend» Google-MapsWojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
93-411 Lodz
PolandNoch nicht rekrutierend» Google-MapsRadomskie Centrum Onkologii
26-600 Radom
PolandRekrutierend» Google-MapsNarodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
02-781 Warszawa
PolandNoch nicht rekrutierend» Google-MapsIPO Lisboa
1099-023 Lisboa
PortugalNoch nicht rekrutierend» Google-MapsFundação Champalimaud
1400-038 Lisboa
PortugalNoch nicht rekrutierend» Google-MapsChln - Hosp. Santa Maria
1649-035 Lisboa
PortugalNoch nicht rekrutierend» Google-MapsCentro Hospitalar Universitario do Porto, EPE
4099-001 Porto
PortugalNoch nicht rekrutierend» Google-MapsInstituto Portugues de Oncologia
4200072 Porto
PortugalNoch nicht rekrutierend» Google-MapsSHI Sverdlovsk Regional Clinical Hospital #1
620102 Ekaterinburg
Russian FederationNoch nicht rekrutierend» Google-MapsIvanovo Regional Oncology Dispensary
153040 Ivanovo
Russian FederationNoch nicht rekrutierend» Google-MapsCity Clinical Hospital #57
105077 Moscow
Russian FederationNoch nicht rekrutierend» Google-MapsFSBSI 'N. N. Blokhin Russian Cancer Research Center'
115478 Moscow
Russian FederationNoch nicht rekrutierend» Google-MapsRussian Scientific Center of Roentgenoradiology
117997 Moscow
Russian FederationNoch nicht rekrutierend» Google-MapsI.M. Sechenov First Moscow State Medical University
119991 Moscow
Russian FederationNoch nicht rekrutierend» Google-MapsCentral Clinical Hospital
121359 Moscow
Russian FederationNoch nicht rekrutierend» Google-MapsHertzen Oncology Research Institute
125284 Moscow
Russian FederationNoch nicht rekrutierend» Google-MapsPrivolzhsky District Medical Center under the Federal Medico-Biological Agency
603109 Nizhni Novgorod
Russian FederationNoch nicht rekrutierend» Google-MapsClinical Oncology Dispensary
644013 Omsk
Russian FederationNoch nicht rekrutierend» Google-MapsLLC Novaya Clinica
357500 Pyatigorsk
Russian FederationNoch nicht rekrutierend» Google-MapsPrivate Medical Institution Euromedservice
196603 Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-MapsSPb SBIH 'City Clinical Oncological Dispensary'
197022 Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-MapsClinical hopital n/a Petra velikogo
195067 Saint-Petersburg
Russian FederationNoch nicht rekrutierend» Google-MapsRussian Scientific Center of Radiology and Surgical Technologies
197758 Saint-Petersburg
Russian FederationNoch nicht rekrutierend» Google-MapsMultifunctional clinical medical center 'Medical city'
625041 Tyumen
Russian FederationNoch nicht rekrutierend» Google-MapsHosp. Virgen de La Victoria
29010 Málaga
SpainRekrutierend» Google-MapsComplejo Hosp. de Navarra
31008 Navarra
SpainNoch nicht rekrutierend» Google-MapsClinica Univ. de Navarra
31008 Pamplona
SpainNoch nicht rekrutierend» Google-MapsHosp. Clinico Univ. Lozano Blesa
50009 Zaragoza
SpainNoch nicht rekrutierend» Google-MapsHosp. Univ. Miguel Servet
50009 Zaragoza
SpainNoch nicht rekrutierend» Google-MapsUrologiska Mottagningen
205 02 Malmö
SwedenNoch nicht rekrutierend» Google-MapsSödersjukhuset
11883 Stockholm
SwedenNoch nicht rekrutierend» Google-MapsHacettepe Uni Medical Faculty Dept. of Urology
06100 Ankara
TurkeyNoch nicht rekrutierend» Google-MapsAnkara University Medical Faculty
06590 Ankara
TurkeyNoch nicht rekrutierend» Google-MapsDr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
6200 Ankara
TurkeyNoch nicht rekrutierend» Google-MapsIstanbul University Cerrahpasa Medical Faculty
34096 Istanbul
TurkeyNoch nicht rekrutierend» Google-MapsBakirkoy Training and Research Hospital
34147 Istanbul
TurkeyNoch nicht rekrutierend» Google-MapsGoztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
34722 Istanbul
TurkeyNoch nicht rekrutierend» Google-MapsKartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi
34890 Istanbul
TurkeyNoch nicht rekrutierend» Google-MapsDokuz Eylul Universitesi Tip Fakültesi Hastanesi
35340 Izmir
TurkeyNoch nicht rekrutierend» Google-MapsSakarya Üniversitesi Tıp Fakültesi Hastanesi
54187 Sakarya
TurkeyNoch nicht rekrutierend» Google-Maps
Studien-Informationen
Detailed 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.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Histologically confirmed adenocarcinoma of the prostate
- Previously treated with radical prostatectomy with lymph node dissection and first
post-operative prostate-specific antigen (PSA) measurement of less than (<) 0.1
nanogram/milliliter (ng/mL) between Week 6 and Week 13
- 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 or 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 at
diagnosis or time of surgery, OR PSADT less than or equal to (<=) 12 months at the
time of screening using at least 3 consecutive values >=0.1 nanogram per milliliter
(ng/mL), from time of BCR, estimated using the Memorial Sloan Kettering Cancer Center
online calculator
- No evidence of 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 metastatic disease 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
- 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
Studien-Rationale
Primary outcome:1. Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS) (Time Frame - Up to 7 years):
ppMPFS is defined as the appearance of at least 1 new PSMA-PET-positive distant lesion compared with the previous scan as assessed by blinded independent central review (BICR) or death.
Secondary outcome:
1. Time to Prostate-Specific Antigen (PSA) Progression (Time Frame - Up to 7 years):
Time to PSA progression is defined as the time from randomization to the date of first documentation of PSA progression. PSA progression is defined as a PSA concentration above the nadir of more than 0.5 nanogram per milliliter (ng/mL), confirmed by repeated measurement at least 3 Weeks later.
2. PSA Response Rate (Time Frame - Up to 7 years):
PSA response rate is defined as the percentage of participants with a PSA decrease of >= 50 percent (%), >= 90% or undetectable from baseline.
3. PSA Levels at Week 26 (Time Frame - Week 26):
PSA levels at week 26 will be reported.
4. Time to Loco-Regional Progression by PSMA-PET (Time Frame - Up to 7 years):
Time to loco-regional progression by PSMA-PET as assessed by blinded independent central review (BCIR) is defined as the time from randomization to the date of the first occurrence of PSMA-PET loco-regional progression. Criteria for PSMA-PET loco-regional progression: Appearance of at least one new PSMA-PET-positive loco-regional lesion compared with the previous scan.
5. Overall Survival (Time Frame - Up to 7 years):
Overall survival is defined as the time from randomization to date of death from any cause.
6. Prostate Cancer-Specific Survival (Time Frame - Up to 7 years):
Prostate cancer-specific survival is defined as the time from randomization to date of death due to prostate cancer.
7. Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAEs) (Time Frame - Up to 7 years):
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
Studien-Arme
- Active Comparator: Interventional Cohort (Group 1): RT+ LHRHa
Participants who are PSMA-PET-positive will receive radiotherapy (RT) which is defined as prostate-bed plus pelvic lymph node salvage external-beam radiotherapy with or without optional stereotactic body radiation therapy (SBRT), along with a luteinizing hormone-releasing hormone agonist (LHRHa) as a 3-monthly depot preparation on Day 1 and at Day 85, or as a 6-monthly depot preparation on Day 1. - Experimental: Interventional Cohort (Group 2): RT+LHRHa + Apalutamide
Participants who are PSMA-PET-positive receive prostate-bed plus pelvic lymph node salvage external-beam radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), along with a LHRHa as a 3-monthly depot preparation on Day 1 and at Day 85, or as a 6-monthly depot preparation on Day 1. Participants will also receive 240 milligram (mg) of apalutamide starting at Day 1 as film-coated tablets, to be swallowed whole and together once daily with or without food, for a period of 180 Days. - No Intervention: Observational Cohort(Group3) PSMA-PET Negative Particitpans
Participants who are PSMA-PET-negative at screening,, will be enrolled in the Observational Cohort. Data collected in the course of routine clinical practice during this period will include clinical evaluations, disease progression, therapies administered as per standard-of-care at the study-sites and survival status. For Observational Cohort, information will be entered into the electronic case report form (eCRF) from the medical records at least twice a year.
Geprüfte Regime
- Radiotherapy:
Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization. - LHRHa:
Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation at Day 1 and Day 85 or as a 6-monthly depot preparation at Day 1. - Apalutamide (JNJ-56021927):
Participants will receive therapeutic dose of apalutamide 240 mg tablets once daily for 180 Days.
Quelle: ClinicalTrials.gov