Cytoreductive Prostatectomy in Treating Patients With Newly Diagnosed, Metastatic Prostate Cancer
NCT ID: NCT02458716
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2015-03-06
2020-01-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
NCT00544830
Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer
NCT06854250
[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application
NCT05458544
Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer
NCT03298087
A Study of Definitive Therapy to Treat Prostate Cancer
NCT02716974
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Surgery followed by hormone therapy (ADT)
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.
Robotic Assisted Radical Prostatectomy
Undergo RARP
Conventional open retropubic radical prostectomy
Undergo conventional open RRP
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
LHRH agonist or antagonist (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Robotic Assisted Radical Prostatectomy
Undergo RARP
Conventional open retropubic radical prostectomy
Undergo conventional open RRP
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
LHRH agonist or antagonist (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Evidence of lymph node or bone metastasis by magnetic resonance imaging (MRI)/computed tomography (CT), bone scan, or biopsy (N1Mx or NxM1)
* Give informed consent
* Clinical stage T3 or less (pelvic MRI shows no rectal and ureteral invasion)
* Cleared by the primary medical doctor for surgery
* No prior systemic therapy for metastatic prostate cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
* Refuses or is unable to have pelvic MRI
* Clinical stage T4 (pelvic MRI shows rectal and/or ureteral invasion)
* Deemed a poor surgical risk per primary medical doctor
* Received prior therapeutic intervention for metastatic prostate cancer
* Known spinal cord compression or brain or liver metastasis
* Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Rutgers Cancer Institute of New Jersey
OTHER
Rutgers, The State University of New Jersey
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Isaac Yi Kim, MD, PhD, MBA
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Isaac Kim
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope National Medical Center (COH)
Duarte, California, United States
University of California, Irvine (UCI)
Orange, California, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2015-00384
Identifier Type: REGISTRY
Identifier Source: secondary_id
Pro20140001022
Identifier Type: OTHER
Identifier Source: secondary_id
081403
Identifier Type: OTHER
Identifier Source: secondary_id
Pro20140001022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.