Prostate Cancer Clinical Trial
Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
Summary
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.
Full Description
PRIMARY OBJECTIVES:
I. To assess the clinical benefit of combining radical surgery cytoreductive radical prostatectomy (CRP) - with the best systemic therapy (BST) in men with newly diagnosed clinical metastatic prostate cancer (mPCa).
SECONDARY OBJECTIVES:
I. To determine the impact of CRP+BST on time to biochemical progression, cancer-specific 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-?).
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.
ARM II: Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel prior to surgery at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 6 months from time of progression.
Eligibility Criteria
Inclusion Criteria:
Histologically proven adenocarcinoma of the prostate
Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
Clinical stage M1a (distant lymph node positive), 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, cryotherapy, etc.)
Give informed consent
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 Oncology Group (ECOG) performance status of 0 or 1
Hemoglobin (HgB) >= 9 g/dL compatible for surgery
Platelets > 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
Exclusion Criteria:
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 13 Locations for this study
Duarte California, 91010, United States More Info
Principal Investigator
Irvine California, 92868, United States
Los Angeles California, 90033, United States More Info
Principal Investigator
Chicago Illinois, 60637, United States
Louisville Kentucky, 40202, United States
New Brunswick New Jersey, 08903, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Seattle Washington, 98104, United States More Info
Principal Investigator
East Melbourne , 9084, Australia More Info
Principal Investigator
Sako Kyoto, 606-8, Japan
ÅŒsaka-sayama Osaka, 589-8, Japan More Info
Principal Investigator
Goyang-si , , Korea, Republic of More Info
Principal Investigator
Gyeonggi-do , , Korea, Republic of More Info
Principal Investigator
How clear is this clinincal trial information?