A Phase 3 Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Patients with Metastatic Prostate Cancer

2023-503254-12-00 Protocol 64091742PCR3001 Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 6 Mar 2019 · Status Ongoing, recruitment ended · 10 EU/EEA countries · 14 sites · Protocol 64091742PCR3001

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 753
Countries 10
Sites 14

Metastatic Prostate Cancer

To evaluate the effectiveness of niraparib and AAP compared to AAP and placebo

Key facts

Sponsor
Janssen - Cilag International
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
6 Mar 2019 → ongoing
Decision date (initial)
2024-04-09
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Janssen Research & Development, LLC

External identifiers

EU CT number
2023-503254-12-00
EudraCT number
2017-003364-12

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Safety, Efficacy, Others

To evaluate the effectiveness of niraparib and AAP compared to AAP and
placebo

Conditions and MedDRA coding

Metastatic Prostate Cancer

VersionLevelCodeTermSystem organ class
21.1 PT 10036909 Prostate cancer metastatic 100000004864

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes
IPD plan description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. HRR gene alteration (as identified by the sponsor's required assays)
  2. Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
  3. Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy
  4. Able to continue GnRHa during the study if not surgically castrate
  5. Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)

Exclusion criteria 5

  1. Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
  2. Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone [AAP] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting
  3. Symptomatic brain metastases
  4. History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
  5. Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) <= 2 years prior to randomization, or malignancy that currently requires active systemic therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Radiographic progression-free survival (rPFS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Niraparib - capsule - 100 mg

PRD4369298 · Product

Active substance
Niraparib
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Max daily dose
200 mg milligram(s)
Max total dose
200 mg milligram(s)
Max treatment duration
52 Month(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Niraparib tosylate monohydrate+ abiraterone acetate - Film coated tablet- 159.40 mg (eq. 100mg base)+ 500mg

PRD8913617 · Product

Active substance
Niraparib
Other product name
Niraparib tosylate monohydrate + abiraterone acetate
Pharmaceutical form
FILM COATED TABLET
Route of administration
ORAL USE
Max daily dose
1200 mg milligram(s)
Max total dose
1200 mg milligram(s)
Max treatment duration
52 Month(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Niraparib tosylate monohydrate + abiraterone acetate - Film coated tablet- 79.90 mg (eq. 50mg base)+ 500mg

PRD8913616 · Product

Active substance
Niraparib
Other product name
Niraparib tosylate monohydrate + abiraterone acetate
Pharmaceutical form
FILM COATED TABLET
Route of administration
ORAL USE
Max daily dose
1100 mg milligram(s)
Max total dose
1100 mg milligram(s)
Max treatment duration
52 Month(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo for Niraparib

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Auxiliary 7

Prednison acis 5 mg, Tabletten

PRD889556 · Product

Active substance
Prednisone
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
52 Month(s)
Authorisation status
Authorised
ATC code
H02AB07 — PREDNISONE
Marketing authorisation
49572.00.00
MA holder
ACIS ARZNEIMITTEL GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Degarelix

SCP8252543 · ATC

Active substance
Degarelix
Route of administration
INTRAMUSCULAR USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
52 Month(s)
Authorisation status
Authorised
ATC code
L02BX02 — DEGARELIX
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Abiraterone

SCP132446 · ATC

Active substance
Abiraterone
Route of administration
INTRAMUSCULAR USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
52 Month(s)
Authorisation status
Authorised
ATC code
L02BX03 — ABIRATERONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Relugolix

SCP56468552 · ATC

Active substance
Relugolix
Substance synonyms
TAK-385
Route of administration
INTRAMUSCULAR USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
52 Month(s)
Authorisation status
Authorised
ATC code
L02BX04 — RELUGOLIX
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

L02AE · Product

Pharmaceutical form
PHF00243MIG
Route of administration
INTRAMUSCULAR USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
52 Month(s)
Authorisation status
Authorised
ATC code
L02AE — GONADOTROPIN RELEASING HORMONE ANALOGUES
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Abiraterone acetate - tablet - 250 mg

PRD589483 · Product

Active substance
Abiraterone Acetate
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
1000 mg milligram(s)
Max total dose
1000 mg milligram(s)
Max treatment duration
52 Month(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

—

SCP9645195 · ATC

Route of administration
INTRAVENOUS USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
52 Month(s)
Authorisation status
Authorised
ATC code
V09IA0X — TECHNETIUM (99MTC) COMPOUNDS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

109 Total trials 22 Recruiting 86 Ended
Commercial
Sponsor organisation
Janssen - Cilag International
Address
Turnhoutseweg 30
City
Beerse
Postcode
2340
Country
Belgium

Scientific contact point

Organisation
Janssen - Cilag International
Contact name
CTIS Point of Contact

Public contact point

Organisation
Janssen - Cilag International
Contact name
CTIS Point of Contact

Third parties 1

OrganisationCity, countryDuties
Signant Health Global LLC
ORG-100040604
 San Francisco, United States Interactive response technologies (IRT)

Locations

10 EU/EEA countries · 14 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ended 12 1
Czechia Ongoing, recruitment ended 11 1
France Ongoing, recruitment ended 37 2
Germany Ongoing, recruitment ended 9 2
Hungary Ongoing, recruitment ended 17 1
Italy Ongoing, recruitment ended 36 3
Poland Ongoing, recruitment ended 54 1
Portugal Ongoing, recruitment ended 5 1
Spain Ongoing, recruitment ended 45 1
Sweden Ended 9 1
Rest of world
Malaysia, Israel, China, Ukraine, United States, United Kingdom, Canada, Turkey, Taiwan, Korea, Republic of, South Africa, Australia, Brazil, Mexico, Argentina, Russian Federation
 — 518 —

Investigational sites

Belgium

1 site · Ended
Ziekenhuis Aan De Stroom
Oncology, Oosterveldlaan 24, 2610, Antwerp

Czechia

1 site · Ongoing, recruitment ended
Uromedical Center s.r.o.
Urology, Janskeho 544/5, 779 00, Povel

France

2 sites · Ongoing, recruitment ended
Besancon University Hospital Center
Oncology department, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Institut De Cancerologie De L Ouest
Oncology department, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex

Germany

2 sites · Ongoing, recruitment ended
Universitaetsklinikum Muenster AöR
Urology, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Otto Von Guericke Universitaet Magdeburg
Urology, Leipziger Strasse 44, Leipziger Str., Magdeburg

Hungary

1 site · Ongoing, recruitment ended
University Of Szeged
Onkotherápiás Klinika, Koranyi Fasor 12, 6720, Szeged

Italy

3 sites · Ongoing, recruitment ended
Azienda Ospedaliero Universitaria Pisana
Oncologia Universitaria 2, Via Roma 67, 56126, Pisa
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
UOS Day-Hospital di Oncologia, Via Alvaro Del Portillo N 200, 00128, Rome
Istituto Oncologico Veneto
S.S. Oncologia Urogenitale, Via Gattamelata 64, 35128, Padova

Poland

1 site · Ongoing, recruitment ended
Szpitale Pomorskie Sp. z o.o.
Radiotherapy, Ul. Powstania Styczniowego 1, 81-519, Gdynia

Portugal

1 site · Ongoing, recruitment ended
Champalimaud Clinical Centre
Oncology, Avenida Brasilia S/n, 1400-038, Lisbon

Spain

1 site · Ongoing, recruitment ended
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga

Sweden

1 site · Ended
Karolinska University Hospital
Tema Cancer, Onkologiska Kliniken, 171 76, Stockholm, Sweden, Eugeniavagen 3, 171 64, Solna

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2019-03-28 2025-12-19 2019-04-06 2021-08-09
Czechia 2019-05-13 2019-06-10 2021-08-09
France 2019-04-08 2019-05-10 2021-08-09
Germany 2019-07-04 2019-11-12 2021-08-09
Hungary 2019-04-15 2019-04-23 2021-08-09
Italy 2019-04-17 2019-06-03 2021-08-09
Poland 2019-03-06 2019-03-12 2021-08-09
Portugal 2020-01-20 2020-05-14 2021-08-09
Spain 2019-04-11 2019-05-02 2021-08-09
Sweden 2019-04-03 2024-08-27 2019-06-17 2021-08-09

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 54 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_REDACTED Protocol 2023-503254-12 Am7
Protocol (for publication) D4_PF Patient Facing Placeholder EN NA
Recruitment arrangements (for publication) K1_PLACEHOLDER Recruitment Arrangements_BE_Eng_64091742PCR3001 1
Recruitment arrangements (for publication) K1_Placeholder_Recruitment Arrangements _PL_EN_64091742PCR3001 1
Recruitment arrangements (for publication) K1_Placeholder_Recruitment Arrangements_CZ_ENG_64091742PCR3001 1
Recruitment arrangements (for publication) K1_Placeholder_Recruitment Arrangements_ES_EN_64091742PCR3001 1
Recruitment arrangements (for publication) K1_PLACEHOLDER_Recruitment Arrangements_FR_EN_64091742PCR3001 1
Recruitment arrangements (for publication) K1_Placeholder_Recruitment Arrangements_HU_ENG_64091742PCR3001 1
Recruitment arrangements (for publication) K1_Placeholder_Recruitment arrangements_ITA_ENG_64091742PCR3001 1
Recruitment arrangements (for publication) K1_Placeholder_Recruitment arrangements_PT_EN_64091742PCR3001 1
Recruitment arrangements (for publication) K1_Placeholder_Recruitment Arrangements_SE_eng_64091742PCR3001 1
Recruitment arrangements (for publication) K1_Placeholder_Recruitment_Arrangements_DE_EN_64091742PCR3001 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF GDPR_CZ_CZE_64091742PCR3001 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF LTE ICF _PL_PL_64091742PCR3001 7
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF LTE_BE_Ukr_2023-503254-12 6
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF LTE_BE_UKR_2023-503254-12 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF LTE_CZ_CZE_64091742PCR3001 7
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF LTE_ES_SPA_64091742PCR3001 8
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF LTE_HU_HUN_64091742PCR3001 7
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF LTE_PT_PT_64091742PCR3001 9
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF LTE_SE_swe_64091742PCR3001 5
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnancy _PL_PL_64091742PCR3001 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_CZ_CZE_64091742PCR3001 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_ES_SPA_64091742PCR3001 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_HU_HUN_64091742PCR3001 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_PT_PT_64091742PCR3001 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Procedures and visits_CZ_CZE_64091742PCR3001 15
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_BE_Dut_64091742PCR3001 7
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Country LTE_IT_ITA_64091742PCR3001 7
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Country Withdrawal LTE_IT_ITA_64091742PCR3001 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_LTE_FR_FR_64091742PCR3001 8
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Master ICF_LTE_DE_GER_64091472PCR3001 8
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Pregnant Partner_FR_FR_64091742PCR3001 2
Subject information and informed consent form (for publication) REDACTED_L2_Subject wallet card Cohort 3_IT_ITA_64091742PCR3001 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_CZ_CZE_64091742PCR3001 2
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_DE_GER_64091472PCR3001 5
Subject information and informed consent form (for publication) REDACTED_L2_Subject wallet card_ES_SPA_2023-503254-12 7
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_FR_fre_2023-503254-12 4
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_HU_HUN_64091742PCR3001 8
Subject information and informed consent form (for publication) REDACTED_L2_Subject wallet card_IT_ITA_64091742PCR3001 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_PL_PL_ 64091742PCR3001 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_PT_POR_2023-503254-12 1
Synopsis of the protocol (for publication) D1_REDACTED Protocol Synopsis CZ 2023-503254-12 Am7
Synopsis of the protocol (for publication) D1_REDACTED Protocol synopsis EN 2023-503254-12 Am6
Synopsis of the protocol (for publication) D1_REDACTED_Protocol Synopsis SE 2023-503254-12 Am7
Synopsis of the protocol (for publication) D1_REDACTED_Protocol Synopsis_BE_Dut_2023-503254-12 Am7
Synopsis of the protocol (for publication) D1_REDACTED_Protocol Synopsis_BE_Fre_2023-503254-12 Am7
Synopsis of the protocol (for publication) D1_REDACTED_Protocol Synopsis_BE_Ger_2023-503254-12 Am7
Synopsis of the protocol (for publication) D1_REDACTED_Protocol Synopsis_FR_2023-503254-12 Am7
Synopsis of the protocol (for publication) D1_REDACTED_Protocol synopsis_HU_2023-503254-12 Am7
Synopsis of the protocol (for publication) D1_REDACTED_Protocol Synopsis_IT_2023-503254-12 Am7
Synopsis of the protocol (for publication) D1_REDACTED_Protocol Synopsis_PL_2023-503254-12 Am7
Synopsis of the protocol (for publication) D1_REDACTED_Protocol synopsis_PT_2023-503254-12 Am7
Synopsis of the protocol (for publication) D1_REDACTED_Protocol synopsis_SP_2023-503254-12 Am7

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-02-21 Italy Acceptable
2024-04-03
 2024-04-03
2 SUBSTANTIAL MODIFICATION SM-1 2024-09-19 Italy Acceptable with conditions
2025-01-15
 2025-01-16
3 NON SUBSTANTIAL MODIFICATION NSM-1 2025-01-24 Acceptable with conditions
2025-01-15
 2025-01-24
4 SUBSTANTIAL MODIFICATION SM-2 2025-09-29 Italy Acceptable
2025-12-02
 2025-12-03

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