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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00384 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Pro20140001022 | Other Identifier | IRB Number | |
| 081403 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| P30CA072720 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Rutgers Cancer Institute of New Jersey | OTHER |
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This phase I trial studies the side effects of cytoreductive prostatectomy in treating patients with newly diagnosed prostate cancer that has spread from the primary site to other places in the body. Cytoreductive prostatectomy is a type of surgery that removes the prostate and as much of the tumor as possible. When combined with hormone therapy, robotic assisted radical prostatectomy (RARP) or conventional open retropubic radical prostatectomy (RRP) may prolong survival in patients with prostate cancer that has spread.
PRIMARY OBJECTIVES:
I. To determine the safety and feasibility of cytoreductive prostatectomy (to remove as much of the primary cancer as possible) in men with newly diagnosed clinical T1-3N1M0 or T1-3N0M1a-b prostate cancer (herein, collectively referred to as metastatic prostate cancer).
SECONDARY OBJECTIVES:
I. Time to prostate specific antigen (PSA) nadir and castration resistance following cytoreductive prostatectomy and subsequent standard systemic therapy, androgen deprivation.
OUTLINE:
Patients undergo RARP or conventional open RRP. Immediately following surgery, patients receive standard systemic androgen deprivation therapy.
After completion of study treatment, patients are followed up every 90 days for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery followed by hormone therapy (ADT) | Experimental | Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Assisted Radical Prostatectomy | Procedure | Undergo RARP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher | Rate will be calculated for the primary end point, and one-sided Binomial test will be used to compare the rate to the hypothesized value. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section. | Within 90 days after cytoreductive prostatectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Time to PSA nadir | Time to event data will be analyzed using the Kaplan-Meier product limit method. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section. | Up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isaac Kim | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center (COH) | Duarte | California | 91010 | United States | ||
| University of California, Irvine (UCI) |
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| Conventional open retropubic radical prostectomy | Procedure | Undergo conventional open RRP |
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide) | Drug | LHRH agonist or antagonist (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide) |
|
|
| Time to rising PSA while on the standard androgen deprivation therapy |
Time to event data will be analyzed using the Kaplan-Meier product limit method. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section. |
| Up to 3 years |
| Orange |
| California |
| 92868 |
| United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000726 | Androgen Antagonists |
| 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 |
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