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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033343
Receipt No. R000038013
Official scientific title of the study A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancer
Date of disclosure of the study information 2018/07/10
Last modified on 2018/07/10

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Basic information
Official scientific title of the study A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancer
Title of the study (Brief title) A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancer
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Endocrinology and Metabolism Endocrine surgery Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In order to prevent death of prostate cancer, we aim to detect prostate cancer as early as possible and aim at it.
Basic objectives2 Others
Basic objectives -Others By clarifying the characteristics of treatment, we aim to construct a system that can provide optimal treatment to patients.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blood / urinalysis, physical findings, tumor assessment of prostate and pelvic lymph nodes (non-contrast MRI) are performed every 3 months.
Key secondary outcomes Evaluation of complications (international prostate symptom score IPSS (6)), quality of life after surgery (EuroQol 5 Dimension; EQ - 5D (7) and FACT - P (8)) and erectile function (International erectile function score; Evaluation of IIEF 5 (9)) every 3 months.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 radical radical prostatectomy and enlarged lymph node dissection
Interventions/Control_2 Preoperative ADT, radiation outside irradiation, and high dosage rate Tri-modality treatment by internal radiation irradiation (trimodality treatment)
Interventions/Control_3 Combination therapy with preoperative ADT and intensity modulated radiation therapy (nADT + IMRT)
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
40 years-old <=
Age-upper limit
75 years-old >=
Gender Male
Key inclusion criteria Patients diagnosed as high-risk prostate cancer (clinical stage T 2 c or more or Grisons score 8 or more) with PSA 10 ng / ml or more and less than 100 ng / ml.
Patients aged 40 to 75 at the time of consent acquisition.
Patients with Body mass index of 22 - 28 kg / m 2.
Patient who gets consent to this research in written form.
Key exclusion criteria Patients who can not perform MRI and CT using contrast medium.
In patients with prostate volume> 60 mL by findings with transrectal ultrasound during biopsy.
Patients with oral administration of two or more antihypertensive drugs or patients with systolic blood pressure of 160 mmHg or more at the initial visit.
In a medical examination at the initial examination, two or more hypoglycemic drugs or patients taking medication or undergoing insulin treatment.
Patients with abdominal surgery history.
Target sample size 45

Research contact person
Name of lead principal investigator Koshiro Nishimoto
Organization Saitama Medical University International Medical Center
Division name UroOncology
Address 1397-1 Yamane, Hidaka, Saitama 350-1241, Japan
TEL +81-42-984-4111
Email k.nishimoto@keio.jp

Public contact
Name of contact person Koshiro Nishimoto
Organization Saitama Medical University International Medical Center
Division name UroOncology
Address 1397-1 Yamane, Hidaka, Saitama 350-1241, Japan
TEL +81-42-984-4111
Homepage URL http://www.international.saitama-med.ac.jp/chiken/results.php
Email k.nishimoto@keio.jp

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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 埼玉医科大学国際医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 10 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 20 Day
Anticipated trial start date
2018 Year 05 Month 02 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 10 Day
Last modified on
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038013

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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