Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Metastatic Castration-sensitive Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
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 som...
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 metasta...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2027
Estimated Enrollment :
696 Patients enrolled
Trial Details
Trial ID
NCT04497844
Start Date
September 23 2020
End Date
November 1 2027
Last Update
December 5 2025
Active Locations (387)
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1
Urology Centers Of Alabama
Homewood, Alabama, United States, 35209
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
3
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, United States, 85741
4
Greater Los Angeles VA Healthcare System
Los Angeles, California, United States, 90073