Comparing 8 approaches for prostate cancer

Exclusion

• −vi. Participants with a history of hypersensitivity to any of the study drugs or any excipient.
• −Active or known human immunodeficiency virus (HIV) with detectable viral load;
• −Participants will be excluded if ANY of the following criteria are met:
• −i. Received more than 12 weeks of LHRHa prior to registration. ii. Stage T4 prostate cancer by clinical examination or radiologic evaluation. iii. Hypogonadism or severe androgen deficiency as determined by the treating physician, or screeningScreeningThe checks done before joining, to see whether a study fits.Read more → serum testosterone less than 50 ng/dL (1.7 nmol/L) iv. Participants with serious illnesses or medical conditions which could cause unacceptable safety risks or would not permit the participant to be managed according to the protocolProtocolThe detailed plan a study must follow.Read more →. This includes but is not limited to:
• −Active infection or chronic liver disease requiring systemic therapy;
• −Participants with uncontrolled hypertension or diabetes.
• −Uncontrolled or recent clinically significant cardiac disease, including history of any of the following within 12 months prior to screening:
• −Severe or unstable angina, symptomatic pericarditis, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease, coronary artery bypass grafting, coronary angioplasty, stenting, or myocardial infarction; uncomplicated deep vein thrombosis is not considered exclusionary).
• −History of any cardiac arrhythmias that preclude prostatectomy or treatment with study drugs, e.g. ventricular, supraventricular, nodal arrhythmias, or conduction abnormality.
• −v. Participants who are unable to swallow oral medication and/or have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
• −vii. Participants with a history of non-compliance to medical regimens. viii. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would make the participant inappropriate for registration or prostatectomy.
• −x. Receiving concurrent androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to registration.
• −xi. M1 by conventional imaging (CT, bone scan) or PSMA-PET. Participants with oligometastatic (\<3) metastases by PSMA imaging only who are deemed candidates for radical prostatectomy are eligible.
• −ix. Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer.