Unique ID issued by UMIN | UMIN000020206 |
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Receipt number | R000023336 |
Scientific Title | High-dose-rate brachytherapy as monotherapy for intermediate- and high-risk prostate cancer: A phase II clinical trial |
Date of disclosure of the study information | 2015/12/20 |
Last modified on | 2019/09/01 08:42:41 |
High-dose-rate brachytherapy as monotherapy for intermediate- and high-risk prostate cancer: A phase II clinical trial
Monotherapeutic HDR-BT for intermediate- and high-risk prostate cancer: Phase II
High-dose-rate brachytherapy as monotherapy for intermediate- and high-risk prostate cancer: A phase II clinical trial
Monotherapeutic HDR-BT for intermediate- and high-risk prostate cancer: Phase II
Japan |
Prostate cancer
Urology |
Malignancy
NO
To evaluate safety and efficacy of high-dose-rate brachytherapy (HDR-BT) as monotherapy for intermediate- and high-risk prostate cancer. Especially, to confirm that the trial regimen of 40 Gy/5 fractions/3 days is equivalent to the historical refimens of 48-54 Gy/8-9 fractions/5 days or 45.5 Gy/7 fractions/4 days.
Safety,Efficacy
Exploratory
Phase II
5-year actuarial biochemical control rate
5-year actuarial rate of late adverse events (genitourinary and gastrointestinal Grade 3 or more),
5-year actuarial rate of late adverse events (genitourinary and gastrointestinal Grade 2 or more),
and QOL questionnaire (EPIC + SF-8)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Other |
Irradiation using high-dose-rate brachytherapy. In total 40 Gy in five fractions (8 Gy per fraction) will be given, with at least 6-hour intervals, at most twice a day, in consecutive 3 days.
20 | years-old | <= |
80 | years-old | > |
Male
1) Biopsy-proven adenocarcinoma
2) MRI, CT, bone scintigraphy were done, and no lymph node or distant metastasis was detected
3) T1c-4N0M0
4) Intermediate- or high-risk prostate cancer (any of T2b-4, GS >=7, or PSA >=10)
5) No neoadjuvant hormone therapy or <= 1 year if any
6) No apparent deficiency of hematological tests
7) Candidacy of epidural anesthesia
8) Age >=20, <80
9) Written informed consent obtained
1) Active other malignancy
2) Uncontrollable diabetes mellitus
3) Unstoppable anticoagulant drugs
4) Severe neurocognitive disease
5) Collagen disease
6) Previous surgery or irradiation to the pelvis
7) Previous TUR-P
8) Severe BPH or lower urinaly tract symptoms
9) Low-risk prosatate cancer
10) High-risk prostate cancer with all 3 factors of T3-4, GS >=, and PSA >=20
11) Neoadjucant hormone therapy >1 year
12) Castration-resistant prostate cancer
13) The physician juddged contraindication
100
1st name | Takero |
Middle name | |
Last name | Hirata |
Osaka University Graduate School of Medicine
Radiation Oncology
5650871
2-2 Yamadaoka, Suita, Osaka
06-6879-3482
hirata@radonc.med.osaka-u.ac.jp
1st name | Takero |
Middle name | |
Last name | Hirata |
Osaka University Graduate School of Medicine
Radiation Oncology
5650871
2-2 Yamadaoka, Suita, Osaka
06-6879-3482
hirata@radonc.med.osaka-u.ac.jp
Osaka University
None
Self funding
Osaka University Clinical Research Review Committee
2-15 Yamadaoka, Suita, Osaka
06-6210-8321
onaka@dmi.med.osaka-u.ac.jp
NO
大阪大学医学部附属病院(大阪府)
2015 | Year | 12 | Month | 20 | Day |
Unpublished
Open public recruiting
2015 | Year | 12 | Month | 15 | Day |
2015 | Year | 12 | Month | 20 | Day |
2015 | Year | 12 | Month | 15 | Day |
2019 | Year | 09 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023336
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