Unique ID issued by UMIN | UMIN000029312 |
---|---|
Receipt number | R000033433 |
Scientific Title | Local Radiation for T4 Disease of Metastatic Prostate Cancer |
Date of disclosure of the study information | 2018/04/01 |
Last modified on | 2017/09/27 17:15:44 |
Local Radiation for T4 Disease of Metastatic Prostate Cancer
LOR-TIP
Local Radiation for T4 Disease of Metastatic Prostate Cancer
LOR-TIP
Japan |
prostate cancer
Urology |
Malignancy
NO
the purpose of this study is to evaluate the efficacy and safety of local radiation thrapy for metastatic prostate cancer
Safety,Efficacy
local progression-related events free survival
1)PSA response rate
2)PSA-progression-free survival
3)Overall survival
4)Progression-free survival
5)Time to Treatment for local events
6)QOL assessment (SF12, FACT-P)
7)CTCAE ver4.0
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
2
Treatment
Maneuver |
primary androgen deprivation therapy+
Intensity Modulated Radiation Therapy(IMRT) 70~78Gy
primary androgen deprivation therapy
40 | years-old | <= |
Not applicable |
Male
1. Pathologically confirmed prostate cancer with T4 2. No previous cytotoxic intravenous systemic chemotherapy
2. No evidence of clinical progression with 6 months primary androgen depriation therapy
3. >=40 years old
4. able to take oral medications
5. Life expectancy >6 months
6. ECOG PS 0-3
7.a-g WBC>=3000/mm3, Hb>=9g/dl, Plt>=75000/mm3, Serum creatinine <=3.0mg/dl, Total bilirubin <=1.8mg/dl, aspartate aminotransferase <=90 IU/l, alanine aminotransferase<=100 IU/l,
8. Obtained infromed consent with document
1.No previous radiation therapy for prostate cancer
2.Allergy for androgen deprivation therapy
3. Patients who were judged unfit for enrollment by physicians in charge
30
1st name | |
Middle name | |
Last name | Naoya Masumori |
Sapporo Medical University School of Medicine
Department of Urology
S1, W16, Chuo-ku, Sapporo 060-8543, Japan
011-611-2111
masumori@sapmed.ac.jp
1st name | |
Middle name | |
Last name | Kohei Hashimoto |
Sapporo Medical University School of Medicine
Department of Urology
S1, W16, Chuo-ku, Sapporo 060-8543, Japan
011-611-2111
hashimoto.kouhei@sapmed.ac.jp
Sapporo Medical University School of Medicine
Sapporo Medical University School of Medicine
Self funding
NO
2018 | Year | 04 | Month | 01 | Day |
Unpublished
Open public recruiting
2017 | Year | 02 | Month | 11 | Day |
2017 | Year | 04 | Month | 17 | Day |
2017 | Year | 09 | Month | 27 | Day |
2017 | Year | 09 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033433