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Surgical Removal of Prostate Tumor and Antiandrogen Therapy with or without Docetaxel in Treating Men with Newly Diagnosed Metastatic Prostate Cancer
Trial Status: active
This randomized phase II trial studies how well surgical removal of the prostate and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, 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. Surgery, antiandrogen therapy and docetaxel may work better in treating participants with prostate cancer.
Inclusion Criteria
Histologically proven adenocarcinoma of the prostate
Evidence of metastasis by MRI/CT scan, bone scan, or histologic confirmation
Clinical stage M1a (distant lymph node positive), or M1b (bone metastasis), or M1c (solid organ metastasis)
If solitary lesion, metastasis confirmed with either biopsy 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, cyrotherapy, etc.)
Give informed consent
Prostate deemed resectable by surgeon
Must be male and 18 years or older
Plans to start or has already started antiandrogen therapy (ADT) no longer than 6 months prior to consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Hemoglobin (HgB) >= 9 g/dL compatible for surgery
Platelets > 80,000 compatible for surgery
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2 x upper limit of normal (ULN) compatible for surgery
Exclusion Criteria
Males under the age of 18
Refuses to give informed consent
Deemed to have unresectable disease by surgeon
Received ADT for more than 6 months prior to consent
Life expectancy of less than 6 months prior to consent
Active spinal cord compression
Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months prior to consent
Previous local therapy for prostate cancer
Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent
Additional locations may be listed on ClinicalTrials.gov for NCT03456843.
I. To assess the clinical benefit of combining radical surgery – cytoreductive radical prostatectomy (CRP) - with the best systemic therapy – to be determined by the treating physician (BST) in men with newly diagnosed clinical M1a, M1b, or M1c metastatic prostate cancer (mPCa).
SECONDARY OBJECTIVES:
I. To determine the impact of CRP+BST on time to biochemical progression, cancer-specific survival, overall survival, complication rates, and quality of life (QOL) in patients with mPCa.
II. To determine the transcription levels of bone morphogenetic protein -6 (BMP-6) and transforming growth factor-beta (TGF-beta).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician. Additionally, patients undergo blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) on study.
ARM II: Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel within 3 months after surgery at the discretion of the treating physician. Additionally, patients undergo blood sample collection and CT or MRI on study.
After completion of study treatment, patients are followed up every 6 months from time of progression.
