Written informed consent must be obtained prior to any screening procedures Subjects must provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up \r\n* Note: informed consent may be obtained prior to start of the specified screening window\r\n* Note: procedures conducted as part of the subjects routine clinical management (e.g., blood count, imaging study such as bone scan) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements Written informed consent must be obtained prior to any screening procedures other than procedures performed as part of standard of care. Written informed consent obtained prior to any study-specific procedures not considered part of routine medical care. Written informed consent for screening and trial participation procedures including biological material transfer and handling. Written informed consent obtained prior to any study-specific procedures not considered part of routine medical care Written informed consent obtained prior to any study-specific procedures not considered part of routine medical care Provide written informed consent obtained prior to the initiation of study procedures Signed written informed consent obtained prior to study procedures Written informed consent must be obtained prior to any screening procedures Signed written informed consent obtained prior to study procedures Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures Written informed consent obtained from the subject prior to performing any protocol-related procedures signed written informed consent obtained prior to study procedures Written informed consent obtained prior to any screening procedures Written informed consent obtained prior to biopsies and blood samples Written informed consent obtained prior to biopsies and blood samples Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the study treatment regimen and follow-up, must be obtained and documented according to the local regulatory requirements Written informed consent must be obtained prior to enrolling in the rollover study and receiving the study treatment. If consent cannot be expressed in writing, then the consent must be formally documented and witnessed, ideally via an independent trusted witness Ability to provide written informed consent for the protocol must be obtained prior to any screening procedures; if consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness Signed written informed consent must be obtained prior to any study procedures. Written informed consent for the protocol must be obtained prior to any screening procedures PHASE I STUDY ELIGIBILITY CRITERIA:\r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluations Written informed consent must be obtained prior to any screening procedures Written informed consent obtained prior to enrolling in roll-over study and receiving study medication If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subjects routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol Written informed consent must be obtained from all patients prior to any study procedures Written informed consent must be obtained prior to any procedures unless considered standard of care. Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol Written informed consent prior to initiation of any study-related procedures; Written informed consent obtained from subject prior to any protocol related procedures Informed consent must be obtained from all subjects prior to beginning therapy Signed written informed consent and assent forms (if applicable) must be obtained prior to any study procedures Written informed consent must be obtained prior to any screening procedures Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements. Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures; written informed consent obtained prior to any study-related procedures. Written informed consent must be obtained prior to any screening procedures Informed consent must be obtained prior to study initiation Subjects must provide written informed consent within one month prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up\r\n* Note: informed consent will be obtained after establishing the diagnosis of high risk, localized prostate cancer, and may be obtained prior to start of the specified screening window\r\n* Note: procedures conducted as part of the subjects routine clinical management (e.g., blood count, imaging study such as bone scan) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol Written informed consent must be obtained prior to any study-related procedures Written informed consent obtained prior to any screening procedures performed Written informed consent obtained prior to any screening procedures Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subjects routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol Informed consent must be obtained in writing for all patients prior to performing study/screening procedures and prior to registration into the study Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up \r\n* Procedures conducted as a part of routine clinical management of the subject (e.g., blood count, imaging study) and obtained prior to signed informed consent may be utilized for screening or baseline purposes provided these tests are obtained as specified in the protocol) Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up; procedures conducted as part of the subjects routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subjects routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol EXPANSION COHORT ONLY: Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subjects routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol Written informed consent must be obtained prior to any screening procedures Written informed consent obtained before undergoing any study-related activities Patients must have a written informed consent obtained prior to the initiation of study procedures Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up; procedures conducted as part of the subjects routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol; Note: it is not necessary that informed consent be obtained within the protocol-specified screening window Written informed consent has been obtained prior to the performance of any protocol-specific procedure. Written informed consent has been obtained prior to the performance of any protocol-specific procedure. Before any study-specific procedure is performed, the appropriate written informed consent must be obtained Ability to provide written informed consent for the protocol must be obtained prior to any screening procedures; if consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness Written informed consent must be obtained prior to any procedures Informed consent must be obtained prior to any study-related procedures; consent will be obtained from a parent or guardian of eligible subjects, or the patient if >= years old; oral assent will be obtained from minor subjects >= years old, unless more stringent requirements are imposed by a sites local institutional review board Written informed consent prior to any study-related procedures Written informed consent prior to any study-related procedures Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subjects routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol \r\n* Note: it is not necessary that informed consent be obtained within the protocol specified screening window Written informed consent must be obtained prior to any baseline/screening procedures.