A Study Of Niraparib Combined With Abiraterone Acetate And Prednisone Versus Abiraterone Acetate And Prednisone To Treat Metastatic Prostate Cancer

Overview

About this study

The objectives of this study are to determine if Niraparib, Abiraterone Acetate (AA), and Prednisone compared with AA and Prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated mCSPC provides superior effectiveness in improving radiographic progression-free survival (rPFS), to assess the clinical benefit of niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC, to characterize the safety profile of niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male patients, ≥ 18 years of age.
  • 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 ≥ 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):
    • 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;
    • ≤ 6 months of androgen deprivation  therapy (ADT) prior to randomization; and
    • 30 days of abiraterone acetate + prednisone (AA-P) allowed if required.

Exclusion Criteria:

  • Patients < 18 years of age.
  • 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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Cassandra Moore, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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