UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed with Metastatic Prostate Cancer
Acronym	Feasibility of Cytoreductive Prostatectomy
Scientific Title	Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed with Metastatic Prostate Cancer
Scientific Title:Acronym	Feasibility of Cytoreductive Prostatectomy
Region	Japan Asia(except Japan) North America

Condition
Condition	metastatic prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the safety and feasibility of cytoreductive prostatectomy in men with newly diagnosed clinical T1-3N1M0 or T1-3N0M1a-b prostate cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	the rate of major peri-operative complications (Clavien-Dindo grade III or higher, please see appendix A) that occur within 90 days after cytoreductive prostatectomy.
Key secondary outcomes	1) time to PSA nadir and 2) time to rising PSA while on standard systemic therapy.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Patients deemed to have cT3 or less will be offered the Robotic Assisted Radical Prostatectomy (RARP).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1 Histologically proven adenocarcinoma of the prostate. 2 Evidence of lymph node or bone metastasis by MRI/CT, bone scan, or biopsy (N1Mx or NxM1). 3 Give informed consent. 4 Clinical stage T3 or less (pelvic MRI or CT scan shows no rectal and ureteral invasion). 5 Must be male and 18 years or older 6 Cleared by the primary medical doctor for surgery. 7 ECOG Performance Status of 0 or 1.
Key exclusion criteria	1 Males under the age of 20. 2 Refuses to give informed consent. 3 Refuses or is unable to have pelvic MRI or CT scan. 4 Clinical stage T4 (pelvic MRI shows rectal and/or ureteral invasion). 5 Deemed a poor surgical risk per primary medical doctor. 6 Known spinal cord compression or brain or liver metastasis or any other visceral metastases. 7 DVT/PE in the past 6 months
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Shigeo Middle name Last name Horie
Organization	Juntendo University Hospital
Division name	Dept. of Urology
Zip code	1138431
Address	3-1-3 Hongo Bunkyo-ku, Tokyo, Japan
TEL	+81-3-3813-3111
Email	shorie@juntendo.ac.jp

Public contact
Name of contact person	1st name Masayoshi Middle name Last name Nagata
Organization	Juntendo University Hospital
Division name	Dept. of Urology
Zip code	1138431
Address	3-1-3 Hongo Bunkyo-ku, Tokyo, Japan
TEL	+81-3-5802-1227
Homepage URL
Email	m-nagata@juntendo.ac.jp

Sponsor
Institute	Juntendo University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	health insurance
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Rutgers Cancer Institute of New Jersey, University of Pennsylvania (Philadelphia, PA), Temple University (Philadelphia, PA), City of Hope (Duarte, CA), University of California at Irvine (Orange, CA), Swedish Medical Center (Seattle, WA), Seoul National University Bundang Hospital (Seoul, Korea)
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Juntendo University Ethics Committee
Address	3-1-3 Hongo Bunkyo-ku, Tokyo, Japan
Tel	03-3813-3111
Email	jun-rinri@juntendo.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	Rutgers Cancer Institute of New Jersey, University of Pennsylvania (Philadelphia, PA), Temple University (Philadelphia, PA), City of Hope (Duarte, CA), University of California at Irvine (Orange, CA), Swedish Medical Center (Seattle, WA), Seoul National University Bundang Hospital (Seoul, Korea)

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 20 Day
Date of IRB	2020 Year 01 Month 31 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 02 Day
Last modified on	2020 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024520