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This study is comparing the drug Niraparib combined with Abiraterone acetate and Prednisone against Abiraterone acetate and Prednisone alone in patients with metastatic castration-sensitive prostate cancer who carry a deleterious homologous recombination repair (HRR) gene mutation. Men with prostate adenocarcinoma, an appropriate HRR gene alteration and metastatic disease are eligible. The study is in Phase 3 and is active but not currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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)