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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000047536 |
Receipt No. | R000054210 |
Scientific Title | Biochemistry-like based on the prostate-specific antigen (Prostate specific antigen: PSA) change by which recurrence relief is receiving radiation treatment after a prostatic cancer operation, adaptation will receive radiation treatment immediately. |
Date of disclosure of the study information | 2022/05/20 |
Last modified on | 2022/06/13 |
Basic information | ||
Public title | Biochemistry-like based on the prostate-specific antigen (Prostate specific antigen: PSA) change by which recurrence relief is receiving radiation treatment after a prostatic cancer operation, adaptation will receive radiation treatment immediately. | |
Acronym | Prostate relief | |
Scientific Title | Biochemistry-like based on the prostate-specific antigen (Prostate specific antigen: PSA) change by which recurrence relief is receiving radiation treatment after a prostatic cancer operation, adaptation will receive radiation treatment immediately. | |
Scientific Title:Acronym | Prostate relief | |
Region |
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Condition | ||
Condition | Prostate cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | When the most suitable relief radiation treatment from which surplus treatment was put aside can be achieved, it's hypothesized to do pelvis lymph node prevention irradiation about PSA fuourei which is being treated in PBRT, and safety and the validity are estimated. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 5th year, Biochemistry-like non-recurrence survival rate |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Treatment measures PSA before treatment and makes PBRT precedent first. PSA is checked in the time 46 Gy applied, and when it's in the standard value calculated based on PSA before treatment, PBRT is continued and irradiation is ended by 68 Gy. When exceeding the standard value, PBRT begins PWRT, and makes PWRT irradiation to 50 Gy to 68 Gy.
Treatment lead period 1~14 days Radiation treatment period 2~3 months Post-observation period 60 months |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
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 |
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Age-upper limit |
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Gender | Male | |||
Key inclusion criteria | 1 cT1~3bN0~1M0,Total prostatectomy,Biochemical recurrence
2 Adenocarcinoma or Tubular adenocarcinoma 3 Performance status0-1 |
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Key exclusion criteria | 1.Chemotherapy has received the whole body method of treatment including hormone treatment.
2.There is radiation treatment in the pelvis in the past. 3.Active overlap cancer |
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Target sample size | 35 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kamagaya General Hospital | ||||||
Division name | Radiation therapy | ||||||
Zip code | 273-0121 | ||||||
Address | 929-6 Hatsutomi, Kamagaya-City Chiba | ||||||
TEL | 047-498-8111 | ||||||
chiken@kamagaya-hp.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kamagaya General Hospital | ||||||
Division name | Radiation therapy | ||||||
Zip code | 273-0121 | ||||||
Address | 929-6 Hatsutomi, Kamagaya-City Chiba | ||||||
TEL | 047-498-8111 | ||||||
Homepage URL | |||||||
chiken@kamagaya-hp.jp |
Sponsor | |
Institute | Kamagaya General Hospital |
Institute | |
Department |
Funding Source | |
Organization | Kamagaya General Hospital |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | The TOKUSHUKAI GROUP ETHICS COMMITTEE |
Address | Emina Building 3F,1-8-7 Koji-machi,Chiyoda-ku,Tokyo |
Tel | 03-3263-4801 |
mirai-ec4@mirai-iryo.com |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054210 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |