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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036012
Receipt No. R000041017
Scientific Title SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 multi-institution randomized prospective clinical trial evaluating the impact of cytoreductive radical prostatectomy combined with best systemic therapy on oncologic and quality of life outcomes in men with newly diagnosed metastatic prostate cancer
Date of disclosure of the study information 2019/04/01
Last modified on 2020/08/28

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Basic information
Public title SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 multi-institution randomized prospective clinical trial evaluating the impact of cytoreductive radical prostatectomy combined with best systemic therapy on oncologic and quality of life outcomes in men with newly diagnosed metastatic prostate cancer
Acronym cytoreductive radical prostatectomy combined with best systemic therapy in men with metastatic prostate cancer (SIMCAP)
Scientific Title SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 multi-institution randomized prospective clinical trial evaluating the impact of cytoreductive radical prostatectomy combined with best systemic therapy on oncologic and quality of life outcomes in men with newly diagnosed metastatic prostate cancer
Scientific Title:Acronym cytoreductive radical prostatectomy combined with best systemic therapy in men with metastatic prostate cancer (SIMCAP)
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 assess the clinical benefit of combining radical surgery - cytoreductive radical prostatectomy (CRP) - with the best systemic therapy (BST) in men with newly diagnosed clinical N1, M1a, or M1b metastatic prostate cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes The primary endpoint for the Phase 2 portion of this study is the failure-free survival (FFS) rate at two years after randomization. Failure is defined as: biochemical recurrence, clinical progression, or death from prostate cancer.
Key secondary outcomes There are seven secondary endpoints: 1) % PSA nadir < 0.2 ng/ml at six months after randomization, 2) overall complication rate, 3) time to biochemical progression, 4) time to clinical progression, 5) FFS (primary endpoint for phase 2 portion), 6) cancer-specific survival, and 7) overall survival (primary endpoint for phase 3 portion). Overall survival will switch to the primary endpoint if the study converts successfully to phase 3 trial.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 cytoreductive prostatectomy
Interventions/Control_2 systemic therapy alone
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
80 years-old >=
Gender Male
Key inclusion criteria 1 Histologically proven adenocarcinoma of the prostate.
2 Evidence of metastasis by MRI/CT scan, bone scan, or histologic confirmation.
3 Clinical stage N1 (regional node positive), M1a (distant lymph node positive), or M1b (bone metastasis).
4 If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET, bone scan and MRI).
5 No previous local therapy for prostate cancer.
6 Give informed consent.
7 Prostate deemed resectable by surgeon.
8 Must be male and 20 years or older
9 Started ADT no longer than 6 months prior to randomization.
10 ECOG Performance Status of 0 or 1.
11 Organ functions compatible for surgery.
HgB>/= 9 g/dL
Platelets >80,000
PT/PTT WNL
Creatinine </=1.5x ULN
AST/ALT </=2x ULN
TBili WNL
Key exclusion criteria 1 Males under the age of 18.
2 Refuses to give informed consent.
3 Deemed to have unresectable disease by surgeon.
4 Received ADT for more than 6 months prior to randomization.
5 Life expectancy of less than 6 months.
6 Known spinal cord compression.
7 M1c disease (solid organ metastasis).
8 DVT/PE in the past 6 months.
9 Previous local therapy for prostate cancer.
Target sample size 190

Research contact person
Name of lead principal investigator
1st name Shigeo
Middle name
Last name Horie
Organization Juntendo University, Graduate School of Medicine
Division name Department of Urology
Zip code 1138421
Address 3-1-3 Hongo Bunkyo-ku, Tokyo, Japan
TEL 03-5802-1227
Email shorie@juntendo.ac.jp

Public contact
Name of contact person
1st name Masayoshi
Middle name
Last name Nagata
Organization Juntendo University, Graduate School of Medicine
Division name Department of Urology
Zip code 1138421
Address 2-1-1 Hongo Bunkyo-ku, Tokyo, Japan
TEL 03-5802-1227
Homepage URL
Email m-nagata@juntendo.ac.jp

Sponsor
Institute Rutgers Cancer Institute of New Jersey
Institute
Department

Funding Source
Organization Department of Urology, Juntendo University, Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University Hospital Ethics Committee Secretariat
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel 03-5802-1584
Email kenkyu5858@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 京都大学附属病院(京都府)、秋田大学附属病院(秋田県)、近畿大学付属病院(大阪府)、弘前大学附属病院(青森県)、アメリカ合衆国 (13施設)、韓国 (5施設)、香港 (1施設)、シンガポール (1施設)

Other administrative information
Date of disclosure of the study information
2019 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 26 Day
Date of IRB
2018 Year 11 Month 26 Day
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2025 Year 05 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
2019 Year 02 Month 26 Day
Last modified on
2020 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041017

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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