UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044546 |
|---|---|
| Receipt number | R000050893 |
| Scientific Title | Stereotactic ablative radiation against metastatic lesion detected by DWIBS for High risk Prostate Cancer |
| Date of disclosure of the study information | 2021/06/15 |
| Last modified on | 2021/08/05 09:11:44 |
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Basic information
Public title
Stereotactic ablative radiation against metastatic lesion detected by DWIBS for High risk Prostate Cancer
Acronym
STARCAP
Scientific Title
Stereotactic ablative radiation against metastatic lesion detected by DWIBS for High risk Prostate Cancer
Scientific Title:Acronym
STARCAP
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Diffusion-weighted whole-body imaging with background body signal suppression will be applied to non-metastatic (with conventional radiographic analysis: CT scan and bone scintigraphy) high risk prostate cancer with radical prostatectomy. If the metastatic lesions will be pointed out, metastatic-directed radiotherapy after radical therapy will be performed. The aim of this study is to evaluate whether this early control of metastatic lesions will prolong diseases free survival and will be safe compared to historical control of the same kind of diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
3-year composite disease progression free survival rate
Key secondary outcomes
progression-free survival
the rate of adverse events
QOL
recurrence rate of metastatic lesion with SBRT
detection rate of DWIBS
time to CRPC
time to new metastatic lesion
rate of hormonal therapy 36-months after protocol therapy
rate of metastatic-directed therapy
Analysis of survival and other clinical parameters with historical control of high risk prostate cancer using propensity-score matching method
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
Metastatic-directed radiation therapy against DWIBS positive lesion after radical prostatectomy with extended pelvis lymph node dissection(if number of DWIBS positive lesion 4 or less)
Hormonal therapy (LHRH monotherapy)after radical prostatectomy with extended pelvis lymph node dissection (if number of DWIBS positive lesion 5 or more)
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
| 25 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Diagnosis of prostate adenocarcinoma as confirmed by a genitourinary pathologist
2) High risk prostate cancer according to NCCN classification (serum PSA >20 ng/mL OR ISUP Gleason grade group 4 or more OR cT>=3a )
3) No lymph node and distant metastasis confirmed by CT scan and bone scintigraphy
4) Patients who exhibited DWIBS positive (metastatic lesions detected) by two independent radiologists
5) Prostate cancer detected by Prostate 1.5T or higher sophisticated MRI before radical prostatectomy
6) Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
7) Patient is suitable for radical prostatectomy with PLND and radiation/hormonal therapy
8) Ability to give voluntary written informed consent to participate in this study.
Key exclusion criteria
1) History of any prostate cancer therapy
2) Severe heart disease (NYHA criteria>=class 3)
3) Cerebral vascular disease with higher cerebral dysfunction
4) Liver disease (total bilirubin> 3*ULN OR ALT/AST>5* ULN)
5) Uncontrollable diabetes mellitus (HbA1c >8.0%)
6) Contraindication for MRI
7) Patient who is considered ineligible for enrolling the study by a principal investigator or sub-investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Inoue |
Organization
Mie University Hospital
Division name
Nephro-Urologic Surgery and Andrology
Zip code
514-8507
Address
2-174 Edobashi Tsu, Mie 514-8507 Japan
TEL
059-232-1111
tinoue28@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Sasaki |
Organization
Mie University Hospital
Division name
Nephro-Urologic Surgery and Andrology
Zip code
514-8507
Address
2-174 Edobashi Tsu, Mie
TEL
059-232-1111
Homepage URL
t-sasaki@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
None
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
Clinical Research Support Center, Mie University Hospital
Address
2-174 Edobashi Tsu, Mie
Tel
059-231-504
kk-sien@med.mie-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 15 | 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
| 2021 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2021 | Year | 06 | Month | 15 | Day |
Last modified on
| 2021 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050893
