Brief Summary
This randomized phase II trial studies how well surgical removal of the prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs that has spread to other places in the body. Androgens can cause the growth of prostate cancer cellsthe basic structural and functional unit of all living things. Antiandrogen therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence, antiandrogen therapy and docetaxel may work better in treating participants with prostate cancer.
Intervention / Treatment
- Drug: Antiandrogen Therapy
- Drug: Docetaxel
- Other: Laboratory Biomarker Analysis
- Procedure: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Procedure: Radical Prostatectomycomplete or partial removal of the prostate gland
Inclusion Criteria
- Histologically proven adenocarcinomacancer arising from mucus-producing glands in organs of the prostate
- Evidence of metastasiswhen the cancer has spread to other parts of the body, also known as mets by magnetic resonance imagingtests that create detailed images of areas inside the body (MRI)/computed tomography (CT) scan, bone scana type of medical imaging that uses a radioactive tracer to detect bone conditions or abnormalities, or histologic confirmation
- Clinical stage M1a (distant lymph nodea small lump or mass of tissue in your body positive), M1b (bone metastasis), or M1c (solid organ metastasis.
- If solitary lesion, metastasis confirmed with either biopsyremoval of a section of tissue to analyse for cancer cells or two independent imaging modalities (i.e. CT and PET [positron emission tomography], bone scan and MRI, modality at the discretion of the treating physician)
- No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapythe process of freezing off cancerous tumours and/or lesions using liquid nitrogen, etc.)
- Give informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.
- Prostate deemed resectable by surgeon
- Plans to start or has already started antiandrogen therapy (ADT) no longer than 6 months prior to consent
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1
- Hemoglobin (HgB) >= 9 g/dL compatible for surgery
- Plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding > 80,000/mcL compatible for surgery
- Aspartate aminotransferase (AST) =< 2x upper limit of normal (ULN) compatible for surgery
- Alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible for surgery