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Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: Male
Things to know
Study dates
Study start: 2018-03-14
Primary completion: 2024-10-31
Study completion finish: 2024-10-31
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT03456843
Intervention or treatment
DRUG: Antiandrogen Therapy
DRUG: Docetaxel
OTHER: Laboratory Biomarker Analysis
PROCEDURE: Quality-of-Life Assessment
OTHER: Questionnaire Administration
PROCEDURE: Radical Prostatectomy
Conditions
- • Stage IV Prostate Adenocarcinoma AJCC v7
Find a site
Closest Location:
Epworth Healthcare
Research sites nearby
Select from list below to view details:
Epworth Healthcare
East Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Arm I (ADT, docetaxel)
| DRUG: Antiandrogen Therapy
|
EXPERIMENTAL: Arm II (ADT, radical prostatectomy, docetaxel)
| DRUG: Antiandrogen Therapy
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Failure-free survival (FFS) | Failure is defined as any one of the following events: PSA progression, clinical progression, radiographic progression, or death from prostate cancer. The % of men who fail within 2 years of randomization will be compare between the two groups using a one-sided log-rank test. | At 2 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Cancer-specific survival | Not Specified | Up to 2 years |
Overall complication rate | Not Specified | Up to 2 years |
Time to biochemical progression | Not Specified | Up to 2 years |
Overall survival | Not Specified | Through study completion, a minimum of 4 years |
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