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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00047 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 081707 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| P30CA072720 | U.S. NIH Grant/Contract | View source | |
| Pro20170001506 | Other Identifier | WIRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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, 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-?).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (ADT, docetaxel) | Experimental | Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician. |
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| Arm II (ADT, radical prostatectomy, docetaxel) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiandrogen Therapy | Drug | To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-specific survival | Up to 2 years | |
| Overall complication rate | Up to 2 years | |
| Time to biochemical progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isaac Kim, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| University of California, Irvine |
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| Docetaxel | Drug | To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test. |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Quality-of-Life Assessment | Procedure | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Radical Prostatectomy | Procedure | Undergo cytoreductive radical prostatectomy |
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| Up to 2 years |
| Overall survival | Through study completion, a minimum of 4 years |
| Irvine |
| California |
| 92697 |
| United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| Yale University | New Haven | Connecticut | 06519 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Swedish Medical Services | Seattle | Washington | 98104 | United States |
| Epworth Healthcare | East Melbourne | Australia | 9084 | Australia |
| Chinese University of Hong Kong | Hong Kong | China |
| Kindai University | Ōsaka-sayama | Osaka | 589-8511 | Japan |
| Akita University | Akita | Japan |
| Juntendo University | Tokyo | Japan |
| National Cancer Center | Goyang-si | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| National Taiwan University Hospital | Taipei | Taiwan |
| ID | Term |
|---|---|
| D000726 | Androgen Antagonists |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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