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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) (AMPLITUDE)

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ClinicalTrials.gov Identifier: NCT04497844
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : March 15, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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).

Condition or disease Intervention/treatment Phase
Metastatic Castrate Sensitive Prostate Cancer Drug: Niraparib Drug: Abiraterone acetate (AA) Drug: Prednisone Drug: Placebo for Niraparib Phase 3

Detailed Description:
Prostate cancer is a heterogenous disease and recent genomic analyses have highlighted specific germline and somatic mutations and alternative driver growth signaling pathways in patients with metastatic disease. Abiraterone acetate plus prednisone (AA-P) is an established standard of care for the treatment of participants with mCSPC and is included in widely accepted clinical treatment guidelines. Niraparib is an investigational agent in the castration-sensitive cancer population and has been approved for the treatment of ovarian cancer. The addition of niraparib to the AA-P backbone regimen may improve initial disease control and long-term outcomes compared with AA-P alone in a biomarker selected population. The study will consist of 4 phases; a Prescreening Phase for biomarker evaluation for eligibility only, a Screening Phase, a Treatment Phase, and a Follow-up Phase. Efficacy evaluations include the following: tumor measurements by computed tomography (CT), magnetic resonance imaging (MRI; abdomen, chest, and pelvis), Technetium-99m (99mTc) bone scans, serum prostate sensitive antigen (PSA) evaluations, and patient reported outcomes (PROs). Safety evaluations include incidence of adverse events and clinical laboratory parameters.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 692 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : November 15, 2024
Estimated Study Completion Date : May 7, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Niraparib
Participants will receive Niraparib 200 mg once daily.

Drug: Abiraterone acetate (AA)
Participants will receive AA 1000 mg once daily.

Drug: Prednisone
Participants will receive 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.
 Drug: Prednisone
Participants will receive prednisone 5 mg once daily.

Drug: Placebo for Niraparib
Participants will receive matching placebo for Niraparib once daily.


Outcome Measures
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Primary Outcome Measures :
  1. Radiographic Progression-free Survival (rPFS) [ Time Frame: Up to 47 months ]
    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.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 78 months ]
    OS is defined as the time from date of randomization to date of death from any cause.

  2. Symptomatic Progression-free Survival [ Time Frame: Up to 47 months ]
    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.

  3. Time to Subsequent Therapy [ Time Frame: Up to 47 months ]
    Time to Subsequent Therapy is defined as the time from date of randomization to the date of initiation of subsequent therapy for prostate cancer.

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 78 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497844


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04497844    
Other Study ID Numbers: CR108852
2020-002209-25 ( EudraCT Number )
67652000PCR3002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Hypersensitivity
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Immune System Diseases
Prednisone
Abiraterone Acetate
Niraparib
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors