UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026453 |
|---|---|
| Receipt number | R000030389 |
| Scientific Title | The evaluation of the adverse effects in the prostate cancer patient who received a focal brachytherapy. |
| Date of disclosure of the study information | 2017/03/08 |
| Last modified on | 2020/03/09 14:31:18 |
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Basic information
Public title
The evaluation of the adverse effects in the prostate cancer patient who received a focal brachytherapy.
Acronym
The evaluation of the adverse effects in the prostate cancer patient who received a focal brachytherapy.
Scientific Title
The evaluation of the adverse effects in the prostate cancer patient who received a focal brachytherapy.
Scientific Title:Acronym
The evaluation of the adverse effects in the prostate cancer patient who received a focal brachytherapy.
Region
| Japan |
Condition
Condition
Prostate caner
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the urinary symptoms, sexual functions and defecation symptoms of the patients who received the focal brachytherapy prospectively.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recovery periods from urinary dysfunctions after treatments
it is assessed after the treatments by using IPSS, OABSS, IIEF5, FACT-P, NIHCPSI 1 month, 3 months and every 3 months afterwards.
Key secondary outcomes
sexual function assessed by using IIEF5
rectal bleeding
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
| Maneuver |
Interventions/Control_1
To perform the focal brachytherapy for the patients that were diagnosed with prostate cancers by using the MRI/US fusion guided targeted biopsies. The radiation area is between the half and one eighth of the prostate. The radiation area will be decided according to the location of the prostate cancer. All patients start or continue an intake of the alpha blockers after the focal brachytherapy. It is permitted to add an intake of drugs such as anticholinergic drugs and beta adrenergic agonists for the benign prostatic hyperplasia and the overactive bladder syndromes. Serum PSA will be checked every 3 months until 2 years after treatments and every 6 months afterwards. The emergence of the cancer suspected lesions will be examined by MRI. All patients receive repeat biopsies after 3 years of treatments and when the recurrence of prostate cancers were suspected by a PSA check or the MRI imaging.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients must be under these conditions
1) Patients expect to live more than 10 years after the treatment
2) Prostate cancers are diagnosed by biopsies which they receive in our hospital
3) Patients can receive MRI imaging check and the clinical staging before biopsies is T2aN0.
4) PSA was 20.00 ng/ml or less.
5) The computed tomography (CT) of the chest/abdomen/pelvis and bone scintigraphy do not detect metastatic lesions
6) Functions of the main organs are maintained
6-1) Lliver function; AST and ALT is under 3 times the upper limit of the normal range.
6-2) Heart function;there is no severe abnormality in the electrocardiogram or normal it is confirmed that there is no severe abnormalities by the cardiac ultrasound.
6-3) Renal function; estimated GFR is 15 per minute or more.
7) There is no pubic arch interference in the prostate brachytherapy.
8) It is confirmed at least once that a residual volume is 200 ml or less by an ultrasound.
9) The prostate volume is 50 ml or less by the trans rectal ultrasound.
10) We obtain a written Informed consent of the participation of the study.
11) The result of the prostate biopsy was under these conditions
11-1) The biopsy was performed along the parasagittal, peripheral and base areas of the prostate with an interval of 5 mm. The core number of systematic biopsy is 16 or more and MRI/US fusion-guided biopsy was performed. If the volume of the prostate is small ,the base area of the biopsy can be abbreviated.
11-2) The lesions of the cancer detected core are limited in the targeted area by MRI/US fusion biopsy and the surrounding area.
11-3) The lesions of the cancer detected core was limited in the left or right lobe of the prostate.
12) The result of the biopsy meet any of these Gleason scores and the proportion of the cores.
12-1) Gleason score is 3+3
12-2) Gleason score is 3+4
12-3) Gleason score is 4+3 and the proportion of the core is 50 or less.
Key exclusion criteria
Patients must not be under these conditions
1) Patients who had past surgical histories of benign prostatic hyperplasia.
2) Patients who had severe mental disorders.
3) Patients who had other active cancers
4) Patients who doctors judge as unsuitable for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Matsushima |
Organization
Tokyo Metropolitan Police Hospital
Division name
Department of Urology
Zip code
164-0001
Address
4-22-1 Nakano, Nakano-ku, Tokyo, 164-0001, Japan
TEL
+81-03-5343-5611
hmatsu53@me.com
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Hakozaki |
Organization
Tokyo Metropolitan Police Hospital
Division name
Department of Urology
Zip code
164-0001
Address
4-22-1 Nakano, Nakano-ku, Tokyo, 164-0001, Japan
TEL
+81-03-5343-5611
Homepage URL
yhakozaki11012@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Police Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Police Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Police Hospital Clinical Review Comittee
Address
4-22-1 Nakano, Nakano-ku, Tokyo, 164-0001, Japan
Tel
+81-03-5343-5611
yhakozaki11012@gmail.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
| 2017 | Year | 03 | Month | 08 | Day |
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
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 07 | Day |
Last modified on
| 2020 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030389
