Unique ID issued by UMIN | UMIN000020848 |
---|---|
Receipt number | R000024063 |
Scientific Title | A phase II study on the carbon-ion radiotherapy for T1c-T3N0M0 localized prostate cancer |
Date of disclosure of the study information | 2016/02/03 |
Last modified on | 2023/12/25 14:14:58 |
A phase II study on the carbon-ion radiotherapy for T1c-T3N0M0 localized prostate cancer
Carbon-ion radiotherapy for localized prostate cancer (iROCK-1501PR)
A phase II study on the carbon-ion radiotherapy for T1c-T3N0M0 localized prostate cancer
Carbon-ion radiotherapy for localized prostate cancer (iROCK-1501PR)
Japan |
Localized prostate cancer
Surgery in general | Urology | Radiology |
Malignancy
NO
To evaluate the safety and efficacy of the carbon ion radiotherapy for localized prostate cancer with clinical stage of T1c-T3N0M0 in Kanagawa Cancer Center
Safety,Efficacy
Confirmatory
Explanatory
Phase II
Biochemical progression-free survival at 5 years
1) Overall survival
2) Disease-specific survival
3) Event-free survival
4) Early and late-phase adverse event rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Carbon-ion radiation therapy
A total of 51.6GyE consisting of 12 fractions; once a day 4.3 GyE, 6-8 times for 2 weeks
20 | years-old | <= |
Not applicable |
Male
1) Histologically confirmed primary prostate adenocarcinoma
2) cT1c,T2a,T2b,T2c,T3a,T3b,N0M0, in accordance with UICC 7th (2009)
3) ECOG Performance status is 0, 1 or 2
4) Over 20 of age at registration
5) Untreated patient for prostate cancer, excluding Neoadjuvant endocrine therapy
6) Patients are informed for diagnosis of prostate cancer and independently agree with this study on carbon-ion radiotherapy
1) Patient with past history of radiotherapy for the targeted lesion
2) Patient with castration-resistant prostate cancer
3) Patient with active double cancer
4) Patients with active and intractable infection in the targeted lesion.
5) Patient with metal devices in the lesion
6) Other medical or psychological condition which is unsuitable for carbon-ion therapy
145
1st name | Hiroyuki |
Middle name | |
Last name | Katoh |
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Department of Carbon-ion Radiotherapy
241-8515
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
045-520-2222
hkatoh@kcch.jp
1st name | Hiroyuki |
Middle name | |
Last name | Katoh |
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Ion-beam Radiation Oncology Center
241-8515
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
045-520-2222
hkatoh@kcch.jp
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Self funding
Japan
None
None
Kanagawa Cancer Center IRB
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
045-520-2222
clinical_trials@kcch.jp
NO
2016 | Year | 02 | Month | 03 | Day |
Unpublished
145
This study confirmed safety and efficacy comparable to those reported from prior facilities.
2023 | Year | 12 | Month | 25 | Day |
Completed
2016 | Year | 01 | Month | 05 | Day |
2016 | Year | 01 | Month | 14 | Day |
2016 | Year | 01 | Month | 15 | Day |
2027 | Year | 08 | Month | 31 | Day |
2027 | Year | 08 | Month | 31 | Day |
2027 | Year | 08 | Month | 31 | Day |
2028 | Year | 08 | Month | 31 | Day |
2016 | Year | 02 | Month | 02 | Day |
2023 | Year | 12 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024063