UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036012 |
|---|---|
| Receipt number | 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 15:52:06 |
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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
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
m-nagata@juntendo.ac.jp
Sponsor or person
Institute
Rutgers Cancer Institute of New Jersey
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041017
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