UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021303 |
|---|---|
| Receipt number | R000024520 |
| Scientific Title | Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed with Metastatic Prostate Cancer |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2020/08/20 11:00:05 |
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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
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
m-nagata@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024520
