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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04497844




Registration number
NCT04497844
Ethics application status
Date submitted
31/07/2020
Date registered
4/08/2020
Date last updated
3/05/2021

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)
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)
Secondary ID [1] 0 0
2020-002209-25
Secondary ID [2] 0 0
CR108852
Universal Trial Number (UTN)
Trial acronym
AMPLITUDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castrate Sensitive Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
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 (AA-P) - 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.

Experimental: AA plus Prednisone (AA-P) - 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression-free Survival (rPFS) - 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.
Timepoint [1] 0 0
Up to 47 months
Secondary outcome [1] 0 0
Overall Survival (OS) - OS is defined as the time from date of randomization to date of death from any cause.
Timepoint [1] 0 0
Up to 78 months
Secondary outcome [2] 0 0
Symptomatic Progression-free Survival - Symptomatic progression free survival is defined as time from the date of randomization to the onset of symptoms consistent with progression of metastatic prostate cancer.
Timepoint [2] 0 0
Up to 47 months
Secondary outcome [3] 0 0
Time to Subsequent Therapy - Time to Subsequent Therapy is defined as the time from date of randomization to the date of initiation of subsequent therapy for prostate cancer.
Timepoint [3] 0 0
Up to 47 months
Secondary outcome [4] 0 0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability - 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.
Timepoint [4] 0 0
Up to 78 months

Eligibility
Key inclusion criteria
Inclusion criteria:

- Diagnosis of prostate adenocarcinoma

- Must have appropriate deleterious homologous recombination repair (HRR) gene
alteration

- Metastatic disease as documented by at least one bone lesion

- Androgen deprivation therapy (either medical or surgical castration) must have been
started >=14 days prior to randomization and willing to continue through the treatment
phase.

- Other allowed prior therapy for metastatic castration-sensitive prostate cancer
(mCSPC): (a) maximum of 1 course of radiation or surgical intervention to manage
symptoms of prostate cancer. Radiation with curative intent is not allowed. Radiation
must be completed prior to randomization (b) <= 6 months of androgen deprivation
therapy (ADT) prior to randomization; and (c) 30 days of abiraterone acetate +
prednisone (AA-P) allowed if required
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 0 0
Ashford Cancer Centre - Kurralta Park
Recruitment hospital [6] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [7] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [8] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [9] 0 0
Macquarie University Hospital - North Ryde
Recruitment hospital [10] 0 0
ICON Cancer Care - South Brisbane
Recruitment hospital [11] 0 0
St John of God Subiaco Hospital - Subiaco
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- 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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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT04497844
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04497844