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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000016573 |
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Date of registration:
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26/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Real-time tumor-tracking proton beam therapy for prostate cancer
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Scientific title:
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Real-time tumor-tracking proton beam therapy for prostate cancer - Real-time tumor-tracking proton beam therapy for prostate cancer |
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Date of first enrolment:
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2015/02/25 |
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Target sample size:
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45 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018975 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase I,II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hiroki
Shirato |
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Address:
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North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
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Telephone:
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+81-11-706-5977 |
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Email:
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shirato@med.hokudai.ac.jp |
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Affiliation:
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Hokkaido University Graduate School of Medicine Department of Radiation Medicine |
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Name:
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Shinichi
Shimizu |
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Address:
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North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
060-8638
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Telephone:
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+81-11-706-5977 |
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Email:
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sshing@med.hokudai.ac.jp |
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Affiliation:
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Hokkaido University Graduate School of Medicine Department of Radiation Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Pathologically proven non-adenocarcinoma or mixed type adenocarcinoma of the prostate 2) Clinically obvious lymph node or distant metastasis 3) With active other cancers 4) With severe uncontrolled diabetes 5) With severe heart disease, or some serious complications, i.e., SLE, Scleroderma 6) With an inflammatory bowel syndrome, i.e., Crohn's disease, ulcerative colitis 7) Previous surgical treatment or High-intensity focused ultrasound (HIFU) for prostate 8) Previous chemotherapy for prostate cancer before enrollment 9) Previous surgery to pelvis, except for appendectomy 10) Previous radiotherapy to pelvis 11) With implantable cardioverter defibrillator or permanent pacemaker 12) Allergic to radiation 13) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 14) Cannot be held rest for about 30 minutes 15) Cannot be implanted Au marker in the prostate 16) Weight over 135 kg 17) Unsuitable for enrollment judged by principal investigator
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate cancer
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Intervention(s)
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Real-time tumor-tracking proton beam therapy
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Primary Outcome(s)
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Incidence of early adverse effects within 90 days after real-time tumor-tracking proton beam therapy
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Secondary Outcome(s)
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Relapse free survival, incidence of adverse effect of Grade 3 or higher and cost-effectiveness at 18 months, incidence of dropout and migration of Au markers during treatment period
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Source(s) of Monetary Support
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Ministry of Education, Culture, Sports, Science and Technology
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Ethics review
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Status: YES
Approval date: 20/02/2015
Contact:
crjimu@huhp.hokudai.ac.jp
Hokkaido University Hospital Clinical Research and Medical Innovation Center
+81-11-706-7636
crjimu@huhp.hokudai.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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29/02/2020 |
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URL:
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