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)

ID#: NCT04497844

Age: 18 years - 66+

Gender: Male

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: September 23, 2020

End Date: May 07, 2027

Contact Information:
Study Contact

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).


Inclusion criteria:

- Diagnosis of prostate adenocarcinoma

- Willing to provide an archival tumor tissue sample or a fresh tumor tissue sample. If germline positive for deleterious germline or somatic homologous recombination repair (HRR) gene mutations, an archived or fresh tumor tissue sample is not required

- Metastatic disease documented by greater than or equal to (>=) 1 bone lesion(s) on Technetium-99m (99mTc) bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)

- 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. Participants who start a gonadotropin-releasing hormone (GnRH) agonist less than or equal to (<=) 28 days prior to randomization will be required to take a first-generation anti-androgen for >=14 days prior to randomization. The anti-androgen must be discontinued prior to randomization

- 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

Exclusion criteria:

- Pathological finding consistent with small cell ductal or neuroendocrine carcinoma of the prostate

- 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)