Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
- Men with histologically or cytologically confirmed adenocarcinoma of the prostate
- Prior treatment with one, and only one, NHT (eg, abiraterone, apalutamide,
darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4) or
mCSPC, M0 CRPC, or mCRPC
- Surgical or medical castration, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at
screening
- Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment
defined by at least one of the following: measurable visceral disease (eg, adrenal,
kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic
adenopathy (ie, adenopathy above the aortic bifurcation)
- Progressive disease at study entry as defined by specific criteria for prostate
specific antigen (PSA) progression OR soft tissue disease progression in the opinion
of the Investigator (Note: subjects with bone disease progression alone are not
eligible)
- Age ≥ 18 years old or meeting country definition of adult, whichever is older, on the
day of consent
- ECOG performance status of 0 or 1
- Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events
(CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are
clinically nonsignificant and/or stable on supportive therapy in the opinion of the
Investigator
- Adequate organ and marrow function based upon specific laboratory assessments obtained
within 21 days prior to randomization
- Understanding and ability to comply with protocol requirements
Exclusion Criteria:
- Any prior nonhormonal therapy initiated for the treatment of mCRPC
- Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide,
nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2
weeks before randomization
- Radiation therapy within 4 weeks (2 weeks for bone metastases) prior to randomization
(subjects with clinically relevant ongoing complications from prior radiation therapy
are not eligible)
- Known brain metastases or cranial epidural disease unless adequately treated and
clinically stable at least 4 weeks prior to randomization
- Symptomatic or impending spinal cord compression or cauda equina syndrome
- Concomitant anticoagulation with oral anticoagulants (some specific exceptions apply)
- Administration of a live, attenuated vaccine within 30 days prior to randomization
- Systematic treatment with, or any condition requiring, either corticosteroids (>10 mg
daily prednisone equivalent) or other immunosuppressive medications within 14 days
prior to randomization
- Uncontrolled, significant intercurrent or recent illness
- Major surgery within 4 weeks prior to randomization
- Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per ECG
within 21 days before randomization
- Inability or unwillingness to swallow pills or receive IV administration
- Previously identified allergy or hypersensitivity to components of the study treatment
formulations or history of severe infusion-related reactions to monoclonal antibodies
- Any other active malignancy at time of randomization or diagnosis of another
malignancy within 2 years prior to randomization that requires active treatment (some
exceptions apply such as locally curable cancers that have apparently been cured).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 10/13/22. Questions regarding updates should be directed to the study team contact.