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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



November 2020

Letztes Update:

LHRHa, Apalutamide

Indikation (Clinical Trials):
Prostatic Neoplasms


Erwachsene (18+)

Phase 3

Janssen-Cilag Ltd.



Janssen-Cilag Ltd. Clinical Trial
Study Director
Janssen-Cilag Ltd.


Studienlocations (3 von 74)

Universitatsklinikum Carl Gustav Carcus Dresden
01307 Dresden
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Universitatsklinikum Essen
D-45147 Essen
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Universitaetsklinikum Muenster
48149 Muenster
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Flinders Medical Centre
5042 Bedford Park
AustraliaNoch nicht rekrutierend» Google-Maps
Bundaberg Hospital
4670 Bundaberg
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Saint Vincent's Hospital - Melbourne
3065 Fitzroy
AustraliaNoch nicht rekrutierend» Google-Maps
Genesis Care Hurstville
2220 Hurstville
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Macquarie University Hospital
2109 North Ryde
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Epworth Healthcare
3121 Richmond
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Bundaberg Hospital
4655 Urraween
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Calvary Mater Newcastle
2298 Waratah
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GenesisCare Wembley
6014 Wembley
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Medical University Innsbruck
6020 Innsbruck
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Ordensklinikum Linz GmbH Elisabethinen
4020 Linz
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Universitätsklinikum Salzburg - Landeskrankenhaus
5020 Salzburg
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Medizinische Universität Wien
1090 Wien
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Fakultni nemocnice Plzen, Urologicka klinika
305 99 Plzen
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Urologicka klinika 1.LF UK a VFN
120 00 Praha 2
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Aalborg University Hospital
9000 Aalborg
DenmarkNoch nicht rekrutierend» Google-Maps
Gentofte Herlev Hospital
2730 Herlev
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Centre Hospitalier du Nord
100 Beirut
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St Georges Hospital university medical centre
11 00 2807 Beirut
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American Universitty of Beirut Medical Center
1107 2020 Beirut
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Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
85-796 Bydgoszcz
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Uniwersyteckie Centrum Kliniczne
80-952 Gdansk
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Szpitale Pomorskie Sp. z o.o.
81-519 Gdynia
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Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
25-734 Kielce
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Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
93-411 Lodz
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Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
02-781 Warszawa
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Fundação Champalimaud
1400-038 Lisboa
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Chln - Hosp. Santa Maria
1649-035 Lisboa
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Centro Hospitalar Universitario do Porto, EPE
4099-001 Porto
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Instituto Portugues de Oncologia
4200072 Porto
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SHI Sverdlovsk Regional Clinical Hospital #1
620102 Ekaterinburg
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Ivanovo Regional Oncology Dispensary
153040 Ivanovo
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City Clinical Hospital #57
105077 Moscow
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FSBSI 'N. N. Blokhin Russian Cancer Research Center'
115478 Moscow
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Russian Scientific Center of Roentgenoradiology
117997 Moscow
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I.M. Sechenov First Moscow State Medical University
119991 Moscow
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Central Clinical Hospital
121359 Moscow
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Hertzen Oncology Research Institute
125284 Moscow
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Privolzhsky District Medical Center under the Federal Medico-Biological Agency
603109 Nizhni Novgorod
Russian FederationNoch nicht rekrutierend» Google-Maps
Clinical Oncology Dispensary
644013 Omsk
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LLC Novaya Clinica
357500 Pyatigorsk
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Private Medical Institution Euromedservice
196603 Saint Petersburg
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SPb SBIH 'City Clinical Oncological Dispensary'
197022 Saint Petersburg
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Clinical hopital n/a Petra velikogo
195067 Saint-Petersburg
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Russian Scientific Center of Radiology and Surgical Technologies
197758 Saint-Petersburg
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Multifunctional clinical medical center 'Medical city'
625041 Tyumen
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Complejo Hosp. de Navarra
31008 Navarra
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Clinica Univ. de Navarra
31008 Pamplona
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Hosp. Clinico Univ. Lozano Blesa
50009 Zaragoza
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Hosp. Univ. Miguel Servet
50009 Zaragoza
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Urologiska Mottagningen
205 02 Malmö
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Hacettepe Uni Medical Faculty Dept. of Urology
06100 Ankara
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Ankara University Medical Faculty
06590 Ankara
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Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
6200 Ankara
TurkeyNoch nicht rekrutierend» Google-Maps
Istanbul University Cerrahpasa Medical Faculty
34096 Istanbul
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Bakirkoy Training and Research Hospital
34147 Istanbul
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Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
34722 Istanbul
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Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi
34890 Istanbul
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Dokuz Eylul Universitesi Tip Fakültesi Hastanesi
35340 Izmir
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Sakarya Üniversitesi Tıp Fakültesi Hastanesi
54187 Sakarya
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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.


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


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.


  • 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.


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