History of any second malignancy in the last years; subjects with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible; subjects with other malignancies are eligible if they have been continuously disease free for at least years History of any other malignancies in the last years except in-situ cancer, non-muscle invasive bladder cancer, basal or squamous cell skin cancer are eligible Any other invasive malignancy from which the patient has been disease-free for less than years with the exception of curatively treated basal or squamous cell skin cancer History of malignancy other than multiple myeloma within five years of registration, except adequately treated basal or squamous cell skin cancer Another malignancy excluding basal cell skin cancer Evidence of any other cancer within the past years and < % probability of a year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed). Any other invasive cancer in the past years, except basal cell skin History of malignancy in the last years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least years. Evidence of any other cancer within the past years and < % probability of a year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed). Concurrent malignancy other than Kaposi sarcoma, resectable squamous cell or basal cell skin cancer, or T anal cancer amenable to surgical resection Evidence of any other cancer within the past years and < % probability of a year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed) Any other malignancy except localized prostate cancer, basal or squamous cell skin cancer, localized cervical cancer or breast cancer that has been curatively treated Has any other malignancy diagnosed within years of screening with the exception of basal or squamous cell skin cancer, or non-invasive cancer of the cervix, or any other cancer deemed by the treating physician to be of low-risk for progression or patient morbidity during the study period. Diagnosis or recurrence of invasive cancer other than the present cancer within years (except basal or squamous cell carcinoma of the skin that has been definitively treated). No history of an invasive malignancy (other than this breast cancer, or non-metastatic basal or squamous skin cancers) in the last years Subjects must not have history of an invasive malignancy (other than this breast cancer, or non-metastatic basal or squamous skin cancers) in the last years Any active cancer diagnosis (basal or squamous cell cancers allowed) within the last years for which the patient is receiving active therapy or which is untreated; any cancer diagnosis within the last years that is considered treated and/ or on surveillance may be included in the trial History of other malignancy within the previous years, except basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer. No prior history of keratoacanthoma (well differentiated squamous cell skin cancer variant, often centrally ulcerated); history of basal cell cancer is allowed No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last years Diagnosis of an invasive malignancy within years (other than current prostate cancer or non-metastatic basal or squamous skin cancers) No history of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last years History of another malignancy in the previous years, with a disease-free interval of < years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Previous malignancy other than Colorectal cancer (CRC) in the last years except for basal cell cancer of the skin or pre-invasive cancer of the cervix Invasive cancer other than ovarian cancer within years (except basal or squamous cell carcinoma of the skin that has been definitely treated) History of previous malignancy (except in-situ cancer or basal or squamous cell skin cancer) within past years Concurrent malignancy or a history of previous malignancy treated with curative therapy within the last months (other than squamous/basal cell cancer of the skin or cervical cancer), for which the survival prognosis is < years No concurrent active primary or metastatic cancer other than superficial squamous cell or basal cell skin cancer history of any other malignancy treated within the last years, other than squamous or basal cell skin cancer; Previous history of another cancer within years, except completely removed basal or squamous cell skin cancer. Invasive cancer other than ovarian cancer within years (except basal or squamous cell carcinoma of the skin that has been definitely treated) Have an additional malignancy diagnosed within years of study enrollment with the exception of basal or squamous cell skin cancer or cervical cancer in situ. History of any second malignancy in the last years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. History of any second malignancy in the last years. Patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible Diagnosis or recurrence of invasive cancer other than the present cancer within years (except basal or squamous cell carcinoma of the skin that has been definitively treated) A prior cancer diagnosis within the past three years (except basal cell, surgically treated squamous cell skin cancer, early prostate cancer under observation) History of active malignancy, including basal/squamous cell skin cancer History of active malignancy in the past years (excluding basal/squamous cell skin cancer or prostate cancer with a Gleason score or less) History of active malignancy within the past years (excluding basal/squamous cell skin cancer or prostate cancer with a Gleason score or less) History of other malignancy =< years prior to the registration/randomization evaluation, with the exception of basal cell or squamous cell skin cancer Active malignancy within the past years (excluding HCC, basal/squamous cell skin cancer, or prostate cancer with a Gleason score or less) History of other malignancy =< years prior to the registration/randomization evaluation, with the exception of basal cell or squamous cell skin cancer Prior history of invasive cancer within years of study entry or history of metastatic cancer; exceptions include non-metastatic, curatively treated basal and squamous cell carcinoma of the skin Any malignancy within years of baseline; participants with a history of basal cell or squamous cell skin cancer may be enrolled at the discretion of the investigator History of active co-existing non-prostatic malignancies except basal cell skin cancer or squamous cell skin cancer Active other malignancy (except basal cell or squamous cell skin cancer) within the last years Active other malignancy (except basal cell or squamous cell skin cancer) within the last years