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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04497844
Registration number
NCT04497844
Ethics application status
Date submitted
31/07/2020
Date registered
4/08/2020
Date last updated
23/05/2024
Titles & IDs
Public title
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
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Scientific title
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
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Secondary ID [1]
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2020-002209-25
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Secondary ID [2]
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CR108852
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Universal Trial Number (UTN)
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Trial acronym
AMPLITUDE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-sensitive Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Inflammatory and Immune System
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0
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Niraparib
Treatment: Drugs - Abiraterone acetate (AA)
Treatment: Drugs - Prednisone
Treatment: Drugs - Placebo for Niraparib
Experimental: Niraparib with Abiraterone Acetate plus Prednisone (AAP) - Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily.
Active Comparator: AA plus Prednisone (AAP) - Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily.
Treatment: Drugs: Niraparib
Participants will receive Niraparib 200 mg once daily.
Treatment: Drugs: Abiraterone acetate (AA)
Participants will receive AA 1000 mg once daily.
Treatment: Drugs: Prednisone
Participants will receive prednisone 5 mg once daily.
Treatment: Drugs: Placebo for Niraparib
Participants will receive matching placebo for Niraparib once daily.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Radiographic Progression-free Survival (rPFS)
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Assessment method [1]
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rPFS is defined as time from randomization date to date of radiographic progression or death, whichever occurs first. Radiographic progression will be evaluated by Prostate Cancer Working Group 3 (PCWG3) criteria and Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
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Timepoint [1]
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Up to 47 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from date of randomization to date of death from any cause.
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Timepoint [1]
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Up to 78 months
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Secondary outcome [2]
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Time to Symptomatic Progression
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Assessment method [2]
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Time to symptomatic progression is defined as time from the date of randomization to the date of any of the following (whichever occurs first): a) the use of external beam radiation therapy for skeletal or pelvic symptoms; b) the need for tumor-related orthopedic surgical intervention; c) other cancer-related procedures; d) cancer-related morbid events; e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.
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Timepoint [2]
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Up to 47 months
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Secondary outcome [3]
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Time to Subsequent Therapy
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Assessment method [3]
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Time to Subsequent Therapy is defined as the time from date of randomization to the date of initiation of subsequent therapy for prostate cancer.
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Timepoint [3]
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Up to 47 months
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Secondary outcome [4]
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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Assessment method [4]
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An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. AE does not necessarily have a causal relationship with intervention.
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Timepoint [4]
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Up to 78 months
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Pathological diagnosis of prostate adenocarcinoma
- Must have appropriate deleterious homologous recombination repair (HRR) gene
alteration
- Metastatic disease as documented by conventional imaging with computed tomography (CT)
or magnetic resonance imaging (MRI) (for soft tissue lesions) or 99mTc bone scan (for
bone lesions). Participants with a single bone lesion on Technetium-99m (99mTc) bone
scan with no other non-nodal metastatic disease must have confirmation of bone
metastasis by CT or MRI. Participants with lymph node-only disease are not eligible
- Androgen deprivation therapy (either medical or surgical castration) must have been
started >=14 days prior to randomization and participants be willing to continue
androgen deprivation therapy (ADT) through the treatment phase
- Other allowed prior therapy for metastatic castration-sensitive prostate cancer
(mCSPC): (a) maximum of 1 course of radiation and 1 surgical intervention for
symptomatic control of prostate cancer (example, uncontrolled pain, impending spinal
cord compression or obstructive symptoms). Participants with radiation or surgical
interventions to all known sites of metastatic disease will be excluded from trial
participation. Radiation must be completed prior to randomization (b) Up to a maximum
of 6 months of ADT prior to randomization; (c) Up to a maximum of 45 days of
abiraterone acetate + prednisone (AA-P) prior to randomization (d) Up to a maximum of
2 weeks of ketoconazole for prostate cancer prior to randomization
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- Prior treatment with a poly (adenosine diphosphate-ribose) polymerase inhibitor (PARP
inhibitor)
- History of adrenal dysfunction
- Long-term use of systemically administered corticosteroids (greater than [>] 5
milligrams [mg] of prednisone or the equivalent) during the study is not allowed.
Short-term use (<=4 weeks, including taper) and locally administered steroids (for
example, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically
indicated
- History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia
(AML)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/09/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
27/05/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
696
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Recruitment in Australia
Recruitment state(s)
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Sunshine Coast University Hospital - Birtinya
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St. Vincent's Hospital Sydney - Darlinghurst
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Royal Brisbane and Women's Hospital - Herston
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Royal Hobart Hospital - Hobart
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Ashford Cancer Centre - Kurralta Park
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Liverpool Hospital - Liverpool
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Peter MacCallum Cancer Centre - Melbourne
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Fiona Stanley Hospital - Murdoch
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Macquarie University Hospital - North Ryde
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ICON Cancer Care - South Brisbane
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St John of God Subiaco Hospital - Subiaco
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4575 - Birtinya
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2010 - Darlinghurst
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4029 - Herston
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7000 - Hobart
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5037 - Kurralta Park
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2170 - Liverpool
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3000 - Melbourne
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6150 - Murdoch
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2109 - North Ryde
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4101 - South Brisbane
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6008 - Subiaco
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Recruitment outside Australia
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Montpellier
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France
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Nancy
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France
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Poitiers Cedex
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France
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Quimper
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France
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Saint Mande
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France
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France
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France
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Suresnes
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France
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Tours
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Braunschweig
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Germany
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Germany
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Germany
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Hannover
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Germany
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Koeln
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Germany
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Muenster
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Germany
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Germany
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Nuertingen
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Debrecen
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Hungary
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Gyor
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Hungary
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Israel
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Israel
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Israel
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Italy
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Milano
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Pozzuoli
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Italy
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San Giovanni Rotondo
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Italy
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Busan
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Kuching
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Mexico
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Lublin
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Poland
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Siedlce
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Poland
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Portugal
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Portugal
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Hato Rey
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Russian Federation
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Barnaul
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ivanovo
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Omsk
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Russian Federation
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saransk
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Russian Federation
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Tomsk
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Russian Federation
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Tyumen
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Russian Federation
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Ufa
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Pretoria
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Spain
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Spain
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Castellon
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Spain
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Girona
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Spain
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Spain
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Spain
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Spain
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Valencia
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Göteborg
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Sweden
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Malmö
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Sweden
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Stockholm
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Taiwan
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Bursa
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Sakarya
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Turkey
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Samsun
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Ukraine
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Cherkasy
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Ukraine
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Chernivtsi
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Ukraine
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Dnipro
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kamianske
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Ukraine
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Khakhiv
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Ukraine
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Kharkiv
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Ukraine
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Kherson
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Vinnitsa
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Ukraine
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Zhytomyr
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United Kingdom
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Bangor
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United Kingdom
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Belfast
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United Kingdom
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Brighton
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United Kingdom
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Bristol
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United Kingdom
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Great Maze Pond
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United Kingdom
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Grimsby
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United Kingdom
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Hillingdon
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United Kingdom
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Inverness
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United Kingdom
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London
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United Kingdom
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Oxford
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United Kingdom
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Preston
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United Kingdom
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Sutton
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United Kingdom
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to determine if the combination of niraparib with Abiraterone
Acetate (AA) plus prednisone compared with AA plus prednisone in participants with
deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic
Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving
radiographic progression-free survival (rPFS).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04497844
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
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Address
0
0
Janssen Research & Development, LLC
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Country
0
0
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Phone
0
0
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Fax
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04497844
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