Patients must be able to understand and provide written informed consent Able to understand the nature of this trial and provide written informed consent Able to understand the investigational nature of this study and to provide written consent to participate in it Male or female ? 18 years of age. 4. Weigh ? 35 kg. 5. ECOG performance score 0-2, inclusively. 6. Negative ?-hCG test in women of childbearing potential. 7. Able to understand and comply with the requirements of the study and to provide written informed consent. Able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients. Patients must be able to understand and provide written informed consent PART I: Able to understand and provide informed consent PART II: Able to understand and provide informed consent Able to understand and give written informed consent Patients are able to understand and provide written informed consent prior to trial participation Patients must be willing and able to review, understand, and provide written consent before study enrollment Female or male patients, >18 years of age, able to understand and give written informed consent. Patients must be willing and able to review, understand, and provide written consent before study enrollment Patients must be willing and able to review, understand, and provide written consent before starting therapy Patients must be willing and able to review, understand, and provide written consent before starting therapy Able to understand and willing to provide written informed consent. Male or female patients, ? 18 years of age, able to understand and give written informed consent. Able to understand and provide informed consent Male or female patients, ? 18 years of age, able to understand and give written informed consent Participants must be willing and able to review, understand, and provide written consent before starting any study-specific procedures or therapy. Patients must be willing and able to review, understand, and provide written consent before starting therapy Patients willing and able to review, understand, and provide written consent before starting therapy Patients must be willing and able to review, understand, and provide written consent before starting therapy Able to understand and have the ability to provide written consent Able to understand and provide written informed consent Able to understand and provide written informed consent Patients able to understand the nature of the study and who are willing to give written informed consent; Patients must be willing and able to review, understand, and provide written consent Patients willing and able to review, understand, and provide written consent Patients willing and able to review, understand, and provide written consent before starting therapy Patients who are willing and able to review, understand, and provide written consent Able to understand and willing to provide informed consent for the RPFNA’s and study participation Understand the study procedures and able to provide informed consent Able to read or understand and provide informed consent Able to understand the experimental nature of the study and provide informed consent Participants who are not able to understand or provide written informed consent Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial COHORT 1: Be willing and able to provide written informed consent / assent for the trial COHORT 2: Be willing and able to provide written informed consent/assent for the trial Able and willing to provide written, signed informed consent (assent as appropriate) DONOR: Able and willing to provide written, signed informed consent (assent as appropriate) Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial. Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial. Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial. Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial. Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial HEALTHY SUBJECT: Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the study Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Subjects must be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the study Be willing and able to provide written informed consent/assent for the trial Willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Subjects between 12 and 35 years of age, inclusive, at the time of consent/assent, and able to provide written consent/assent, if applicable. Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Able and willing to sign informed consent/assent Willing to provide informed consent/assent for study participation Willing to provide informed consent/assent for study participation Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Able to provide valid written informed consent Able and willing to give valid written informed consent. Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent; in patients who are not able to consent to the trial due to medical circumstances, the next of kin or power of attorney may consent for the study Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent Able to provide valid written informed consent. Able and willing to give valid written informed consent Able and willing to give valid written consent for available archival tumor samples or fresh tumor biopsies/resections Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent Able and willing to give valid written informed consent. Able and willing to give valid written informed consent Signed written informed consent; patient must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent Able and willing to give valid written informed consent Able and willing to give valid written informed consent. Able and willing to give valid written informed consent. Able and willing to give valid written consent for archival tumor samples Able and willing to give valid written consent for biopsy samples (subjects in the expansion phase only). Able and willing to give valid written informed consent. Participant or legal guardian, in the opinion of the investigator, is capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent; a signed informed consent must be obtained prior to any study specific procedures Valid email address Has a valid driver’s license Patients who cannot provide a valid consent RANDOMIZED CONTROLLED TRIAL: Must also have a valid email address Signed written informed consent (patient must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent) Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent Patients who because of general medical or psychiatric condition or physiologic status cannot give valid informed consent Patient is able and willing to give valid written informed consent Patients who because of age, general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer are unlikely to be candidates for repeat MRIs, or cannot give valid informed consent Valid informed consent by subject Able to provide informed consent prior to initiation of study Able to provide confirmed consent Are willing and able to provide signed informed consent. Patients must be able to provide informed consent. DONOR: Able to provide informed consent for the donation process per institutional standards. Willing and able to provide informed consent. Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation. Willing and able to provide informed consent Participants must be able to provide informed consent for treatment and trial participation Able to provide informed consent and be willing to participate in study schedule and events. Willing and able to provide informed consent Willing and able to provide informed consent Able to provide informed consent In the judgment of the consenting professional cognitively able to provide informed consent Willing and able to provide consent Willing and able to provide consent Patient able and willing to provide informed consent. Willing and able to provide informed consent Patients must be able to provide informed consent Patients must be able to provide informed consent Patients must be able to provide informed consent Patients must be able to provide informed consent Patients must be able to provide informed consent Patients must be able to provide informed consent Able and willing to provide informed consent Must be able to provide informed consent. Able to provide informed consent They must be able to provide informed consent Able to provide signed, informed consent Able to provide informed consent Able to provide informed consent Patients, or appropriate designee, must be able to provide informed consent Able and willing to provide consent for required bone marrow biopsies. Willing and able to provide informed consent DONOR: Willing and able to provide informed consent Participant is able to provide signed informed consent Patients, or appropriate designee, must be able to provide informed consent Willing and able to provide informed consent Patient should be able to provide informed consent COHORT A: The subject must be willing and able to provide informed consent COHORT B: The subject must be willing and able to provide informed consent For adult patient, the patient is able to provide informed consent. For pediatric patient, a parent is able to provide informed consent. Able to provide informed consent and be willing to sign an informed consent form Willing and able to provide informed consent Able to provide informed consent and follow protocol requirements. Patients must be able to provide informed consent Patient or guardian willing and able to provide informed consent. Able to provide informed consent for the study Patients must be able to provide informed consent Willing and able to provide informed consent Patients, or appropriate designee, must be able to provide informed consent At least 18 years of age and willing and able to provide informed consent. Willing and able to provide informed consent Able to provide informed consent Able to provide informed consent, child assent with parental consent or surrogate consent when applicable Willing and able to provide informed consent; Patients must be able to provide informed consent Willing and able to provide informed consent Age 18 years or older and willing and able to provide informed consent; Able to provide informed consent Be able to provide informed consent Patient/partner is able to provide informed consent Able to provide informed consent PATIENT & PARTNER: Able to provide informed consent Able to provide informed consent Must be able to provide own consent PATIENTS AND CAREGIVERS: Able to provide informed consent. Able to provide informed consent Phase I: Able to provide informed consent Phase II: Able to provide informed consent Able to provide informed consent Cannot provide meaningful informed consent In the judgment of the consenting professional cognitively able to provide informed consent In the judgment of the consenting professional cognitively able to provide informed consent Able and willing to provide informed consent PATIENTS AND PARTNERS: Able to provide consent Adults who are able to provide informed consent Willing and able to provide informed consent Willing and able to provide informed consent Not willing and able to provide informed consent Subject is able to provide informed consent Able to provide informed consent Capable and willing to provide Informed consent FCGs: Able to provide informed consent PATIENTS: Not able to provide informed consent Able to provide informed consent Willing and able to provide informed consent Not willing and able to provide informed consent Patients must be able to provide informed consent Able to provide informed consent PHASE I: Able to provide meaningful informed consent PHASE II: Able to provide meaningful informed consent Willing and able to provide signed, informed consent Subjects able to provide informed consent Able and willing to provide consent (both) PATIENT: Be able and willing to provide informed consent Able and willing to provide informed consent Willing and able to provide, signed informed consent Able to provide informed consent The subject must be willing and able to provide informed consent Able to provide informed consent Able to provide informed consent Cognitively able and willing to provide consent Able to provide informed consent in English Subjects willing and able to provide consent to participating in the study Able to provide verbal consent Able to provide informed consent Able to provide informed consent to participate in the study Able to provide informed consent Able to provide informed consent Patients who are willing and capable to provide informed consent Capable and willing to provide informed consent The patient is willing and able to provide informed consent. Able to provide legally effective informed consent Are able to provide informed consent Patients must be capable and willing to provide informed consent Willingness to participate in the study and able to provide informed consent Patients must be able to provide informed consent Patients must be capable and willing to provide informed consent. Able to provide informed consent and follow the study guidelines Patient able and willing to provide informed consent Able to provide informed consent Able to provide informed consent Refusal to provide informed consent HCC PATIENTS: Patient is willing to provide informed consent Are able to provide informed consent Able to provide informed consent The patient must be willing and able to provide informed consent Willing and able to provide informed consent Are able to provide informed consent Be willing and able to provide informed consent NORMAL VOLUNTEERS: Be willing and able to provide informed consent Able to provide informed consent Able to provide informed consent Able to provide informed consent (Pre-pilot phase, Arms 1-4, PCS study) Able to provide informed consent to participate in the study Must be able to provide informed consent Willing and able to provide informed consent and fill out demographic, disease, and pain assessment questionnaires Subject or subject's representative is willing and able to provide written informed consent Willing and able to give written informed consent. Patient is able and willing to provide written informed consent Be willing and able to provide written informed consent for the trial Patient must be capable, willing, and able to provide written, informed consent Willing and able to provide written informed consent. Be willing and able to provide written informed consent for the trial Willing and able to provide written informed consent Be willing and able to provide written informed consent for the trial Able and willing to provide written informed consent to participate in this study. Willing and able to provide written informed consent for the study Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Willing and able to give written, and dated, informed consent Willing and able to provide written informed consent to participate in this investigational study. Subject is willing and able to give prior written informed consent for investigation participation; and Willing and able to give written informed consent Willing and able to give written informed consent Must be able and willing to give written informed consent. Subjects must be willing to give written informed consent per institutional guidelines and must be able and willing to adhere to dose and visit schedules Must be willing and able to provide written informed consent Be willing and able to provide written informed consent for the trial Willing and able to provide written informed consent Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial. Be willing and able to provide written informed consent. Be willing and able to provide written informed consent for the trial Willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Patient must be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Must be willing and able to provide written informed consent Be willing and able to provide written informed consent for the trial Willing to provide informed written consent Be willing and able to provide written informed consent for the trial Willing and able to provide written informed consent. Be willing and able to provide written informed consent for the trial Willing and able to provide written informed consent Willing and able to provide written informed consent for the trial Is willing and able to provide written informed consent for the trial. Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Willing and able to provide written informed consent Be willing and able to provide written informed consent for the trial Willing and able to provide written informed consent Willing and able to provide written informed consent Must be willing and able to provide written informed consent Be willing and able to provide written informed consent for the trial Subjects must be willing to give written informed consent per institutional guidelines and must be able and willing to adhere to dose and visit schedules Willing and able to provide written informed consent Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Willing and able to provide written informed consent Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for trial Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial. Be willing and able to provide written informed consent for the trial Is willing and able to provide written informed consent for the trial Must be able and willing to give written informed consent Be willing and able to provide written informed consent for the trial Patient must be capable, willing, and able to provide written, informed consent Willing and able to give written informed consent Must be willing and able to provide written informed consent Willing and able to give written informed consent Willing and able to provide written informed consent. Be willing and able to provide written informed consent Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial. Must be able and willing to give written informed consent Willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Willing and able to provide written informed consent for voluntary participation in the trial Be willing and able to provide written informed consent for the trial Be willing and able to provide written informed consent for the trial Participant is willing and able to give written informed consent Patient is willing and able to give written informed consent Willing and able to provide written informed consent Able and willing to provide written informed consent Patient willing and able to provide written informed consent Willing to provide written informed consent Must be able and willing to give written informed consent Able and willing to provide written informed consent to participate in the study Patients must be able and willing to give written informed consent Be willing and able to provide written informed consent Be willing and able to provide written informed consent for the trial. Be willing and able to provide written informed consent for the trial Must be willing and able to provide written informed consent Must be willing and able to provide written informed consent Willing and able to give written informed consent. Be willing and able to provide written informed consent for the trial Willing and able to provide informed written consent Able and willing to provide written informed consent Be willing and able to provide written informed consent for the trial Willing and able to give written informed consent Patient must be capable, willing, and able to provide written, informed consent Patient willing and able to provide written informed consent for the trial Willing and able to provide written informed consent Able and willing to provide written informed consent. Willing and able to give written informed consent Willing and able to give written informed consent Willing and able to give written informed consent Willing and able to provide written Informed Consent and adhere to study procedures. Willing and able to provide written informed consent Willing and able to give written informed consent Willing and able to provide written informed consent. Willing and able to provide written informed consent Able and willing to give written informed consent. 4. Patient is able and willing to provide written informed consent to participate in the study. Subject or subject's representative is willing and able to provide written informed consent Subjects must be willing to give written informed consent and be able to adhere to dose and visit schedules. Willing and able to provide written informed consent. Willing and able to give written informed consent Subject is willing to provide written informed consent Able and willing to provide written consent Willing to provide informed written consent Willing and able to provide written informed consent Patients must be willing and able to provide a written informed consent Able and willing to provide written informed consent Patients must be willing and able to provide written informed consent for the trial Willing and able to provide written informed consent Patient must be able and willing to provide written informed consent Participant willing to provide a written informed consent Willing and able to provide written informed consent Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate Willing and able to provide informed written consent Be willing and able to provide written informed consent for the trial Willing and able to provide a written informed consent Willing and able to provide written informed consent Subjects are required to be willing and able to provide written informed consent Be willing and able to provide written informed consent. Patients must be able and willing to provide written informed consent prior to any study related procedure. Be willing and able to provide written informed consent for the trial Able to give written informed consent and comply with all study visits and procedures. Willingness and ability to provide written informed consent prior to any study?related procedures and to comply with all study requirements. Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements Willing and able to provide written Informed Consent and comply with the requirements of the study. Subject should be able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or comorbidity that would interfere with therapy. Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements Willing and able to comply with the study procedure and sign a written informed consent Able to understand and give written informed consent and comply with study procedures. Be willing and able to provide written informed consent for the trial and comply with the study visit requirements Able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the Investigator, to comply with all the requirements of the study. Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements After being fully informed about their illness and the investigative nature of the protocol (including foreseeable risks and possible toxicities), is willing and able comply with the protocol and to provide written, ethics committee-approved informed consent form before performance of any study-specific procedures or examinations Patient has any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements Understand the study requirements and the treatment procedures, and is willing to comply with all specified follow-up evaluations, and provides written informed consent before any study-specific tests or procedures are performed. Ability to provide signed informed consent and willing and able to comply with all study requirements Able to provide informed consent and comply with all study protocols Has any medical or psychiatric disorder that compromises the ability of the subject to give written informed consent, and/or comply with the study procedures. Be willing and able to understand and give written informed consent and comply with all study related procedures Able and willing to provide informed consent and to comply with the study procedures Able to give written informed consent and comply with all study visits and procedures Subject must be able to provide written informed consent, comply with protocol visits and procedures, and take oral medication, and does not have any active infection or comorbidity that would interfere with therapy Able and willing to provide written informed consent prior to performing any study-related procedures and to comply with the study protocol, including patients must be willing and able to use the electronic patient-reported outcome (ePRO) device Must be willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent Patient understands the nature of the procedure, is willing to comply with associated follow–up evaluations, and provide written informed consent prior to the procedure Subject is able to provide written informed consent, comply with protocol visits and procedures, and take oral medication, and does not have any active infection or comorbidity that would interfere with therapy. Able and willing to provide written informed consent and to comply with the study protocol Willing and able to comply with the study procedures and provide written informed consent to participate in the study Adult subjects ?18 years of age who are able to understand study procedures, comply with them, and provide written informed consent before any study-specific procedure. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures); Has provided written informed consent, and has the willingness and ability to comply with all study procedures Adult subjects ?18 years of age who are able to understand and comply with study procedures, and provide written informed consent before any study-specific procedure. Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations Able and willing to provide written informed consent and to comply with the study protocol Be willing and able to provide written informed consent for the trial and comply with the study visit requirements Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements Ability to understand the purpose of the study, provide signed and dated informed consent, and able to comply with all procedures Ability to understand the nature of this study protocol, comply with study and/or follow-up procedures, and give written informed consent Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements. Patients must be willing and able to comply with the protocol and provide written informed consent prior to study specific screening procedures Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements Patients must provide signed, written, informed consent and be willing and able to comply with eligibility requirements, scheduled, visits, and follow-up studies Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Subjects willing and able to comply with all aspects of the protocol for the duration of the study and provide written informed consent before any study-specific screening procedures are performed, with the understanding that the subject may withdraw consent at any time without prejudice Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements. Be willing and able to give written informed consent, and be able to comply with all study procedures Subjects willing and able to comply with the study protocol for the duration of the study and provide written informed consent prior to any study-specific screening procedures with the understanding that the subject may withdraw consent at any time without prejudice. Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures. Willingness and ability to provide written informed consent prior to any study-related procedures and comply with all study requirements. Able to understand and give written informed consent and comply with study procedures. Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements. Able to understand and give written informed consent and comply with study procedures. Ability to give written informed consent and willing to comply with the requirements of the protocol; and for Part 3, to give written informed consent for 2 cancer biopsy procedures Ability to provide written informed consent, comply with protocol visits and procedures, take oral medication, and not have any active infection or chronic comorbidity that would interfere with therapy Subject should be able to provide written informed consent and comply with protocol visits and procedures. The subject has read and understood the written informed consent form (ICF) and is willing and able to give informed consent, fully understands the requirements of the trial and is willing to comply with all trial visits and assessments, including completion of patient-reported measures. Consent must be given before any trial related activities. Must be willing and able to provide written informed consent and comply with the protocol and study procedures Be willing and able to give written informed consent, and be able to comply with all study procedures Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements and for 3 months after last dose. Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study and follow-up procedures. Provide written informed consent and willing to comply with protocol requirements. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures Able to give informed consent, and comply with study procedures Subject capable of providing written informed consent prior to initiation of any study procedures; subjects able to understand and comply with planned study procedures and be available for all study visits Able to provide written informed consent and willing to comply with protocol requirements The subject is able and willing to comply with study procedures and provide signed and dated informed consent The subject is able and willing to comply with study procedures and provide signed and dated informed consent The subject is able and willing to comply with study procedures and provide signed and dated informed consent Subjects able to provide informed consent and agree to comply with study procedures Able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or comorbidity that would interfere with therapy. Ability to give informed consent and to comply with study procedures The subject is able and willing to comply with study procedures and provide signed and dated informed consent Able to provide written informed consent and willing to comply with protocol requirements Provides written informed consent and willing to comply with protocol requirements Provide written informed consent and willing to comply with protocol requirement Able to provide written informed consent. Patients must be able to provide written informed consent Patients must be able to provide written informed consent Able to provide written informed consent Patients must be able to provide written informed consent Patients must be of appropriate mental capacities with sufficient social support so as to be able to complete required study activities (i.e. diet record, etc) and able to provide written informed consent ARM I&II: Patients must be able to provide written informed consent Patients must be able to provide written informed consent Patients must be able to provide written informed consent. Able to provide written informed consent Must be able to provide written informed consent before any screening procedures. Able to provide written informed consent for the trial Able to provide written informed consent. Able to provide written informed consent Subjects must be able to provide written informed consent. Patient able to provide written informed consent; parent or guardian of minor patient able to provide written informed consent Patient able to provide written informed consent for the long-term follow-up gene therapy study: 2006-0676; parent or guardian of minor patient able to provide written informed consent for the long-term follow-up gene therapy study: 2006-0676 Able to provide written informed consent Patients must be able to provide written informed consent Subjects must be able to provide written informed consent Able to provide written informed consent Patient must be able to provide written informed consent Patients must be able to provide written-informed consent Participant must be able to provide written Informed Consent Patients are not able to provide written informed consent to study participation Able to provide written informed consent Able to provide signed, written informed consent Patient able to provide written informed consent. Patient able to provide written informed consent for the long-term follow-up (LTFU) gene therapy study. Patients must be able to provide written informed consent Patients must be able to provide written informed consent Patients must be able to provide written informed consent Subjects or their legal representatives must be able to provide written informed consent. Patients must be able to provide written informed consent Able to provide written informed consent Able to provide written informed consent and to follow protocol requirements. Able to provide informed written consent Subject is able to provide written informed consent. Able to provide informed written consent Patients must be able to provide written informed consent Able to provide written informed consent Subjects must be able to give written consent to the study Able to provide written consent Able to provide written, informed consent Patients must be able to provide written informed consent Patients must be able to provide written informed consent Able to provide written informed consent. Able to provide written informed consent and to follow protocol requirements Subject is able to voluntarily provide written informed consent. Patients must be able to provide written informed consent Able to provide written informed consent Able to provide written informed consent, and agree to practicing 2 forms of birth control during the study Be able to provide written informed consent Able to provide written informed consent Able to provide written informed consent Patients must be able to provide written informed consent Be able to provide written informed consent Able to provide written informed consent Patients must be able to provide written informed consent Patients must be able to provide written informed consent Able to provide written consent Able to provide written consent Patient is able to provide written informed consent prior to study registration Patients must be able to provide written informed consent Patients must be able to provide written informed consent Able to provide written informed consent Able to provide written consent Able to provide written consent Subject and/or guardian is able to provide written informed consent prior to study registration Patient and/or guardian is able to provide written informed consent prior to study registration Patient and/or guardian is able to provide written informed consent prior to study registration Patient and/or guardian is able to provide written informed consent prior to study registration Able to provide written informed consent Patients must be able to provide written informed consent Able to provide written informed consent. Able to provide written consent Able to provide written informed consent Patients must be able to provide written informed consent Patient and/or guardian is able to provide written informed consent prior to study registration Subjects must to able to provide informed written consent prior to study entry Patients must be able to provide written informed consent Must be able to provide a written informed consent Able to provide written informed consent Able to provide written informed consent. Able to provide written informed consent