UMIN-CTR Clinical Trial

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
Email	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
Email	t-sasaki@med.mie-u.ac.jp

Sponsor
Institute	Mie University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050893