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:

- 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)

Eligibility last updated 4/21/22. Questions regarding updates should be directed to the study team contact.

 

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

Alan Bryce, M.D.

Open 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)

International patient clinical studies questions