Prostate cancer does not occur in women. 3.4 Subject Recruitment Subjects will be identified through the clinical practices of the investigator or sub - investigators at participating research s ites and through referrals from outside hospitals and physicians. No direct -to-patient advertising will be performed. 4. REGISTRATION PROCEDU RES 4.1 General Guidelines This study is supported by the NCI Cancer Trials Support Unit (CTSU). Prior to the recruitment of a patient for this study, investigators must be registered and have a current CTEP -IAM account. Each investigator must have an NCI investigator number and must maintain an “active” investigator registration status through the annual submission of a complete investigator registration packet (FDA Form 1572 with original signature, current CV, Supplemental Investigator Data Form with signature, and Financial Disclosure Form with original signature) to the Pharmaceutical Management Branch, CTEP, DCTD, and NCI. These forms are available on the CTSU Web site (enter credentials at https://www.ctsu.org ; then click on the Register tab) or by calling the PMB at (240) 276 -6575 Monday through Friday betw een 8:30 a.m.