UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052842 |
|---|---|
| Receipt number | R000060305 |
| Scientific Title | Longitudinal intervention study using interim treatment-free observation as the initial treatment strategy for stage T1c prostate cancer |
| Date of disclosure of the study information | 2023/11/19 |
| Last modified on | 2023/11/19 18:40:45 |
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Basic information
Public title
Longitudinal intervention study using interim treatment-free observation as the initial treatment strategy for stage T1c prostate cancer
Acronym
Longitudinal intervention study for non-palpable prostate cancer using temporary observation without treatment as initial treatment strategy
Scientific Title
Longitudinal intervention study using interim treatment-free observation as the initial treatment strategy for stage T1c prostate cancer
Scientific Title:Acronym
Longitudinal intervention study for non-palpable prostate cancer using temporary observation without treatment as initial treatment strategy
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Stage T1cN0M0 in prostate cancer patients with favorable biopsy findings, where the lesion is estimated to be small and highly differentiated based on pathological findings from systematic biopsy, temporary observation without treatment is the initial treatment. We will examine the validity of ``patient selection criteria'' and ``criteria for continuing/discontinuing non-treatment follow-up'' that are considered not to increase the risk of death from prostate cancer even if the strategy of active surveillance is implemented. We will continue to follow patients for as long as possible after the primary analysis to determine whether active surveillance does indeed increase the risk of death from prostate cancer. Furthermore, the patient's QOL (Quality of Life) will be evaluated to examine the usefulness of monitoring therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Proportion of patients with a PSA doubling time of more than 2 years at 6 months after enrollment among patients selected for active surveillance
Key secondary outcomes
1) Percentage of patients who met the pathological eligibility criteria at the time of enrollment as a result of re-biopsy among patients selected for active surveillance who underwent re-biopsy performed 13 months after enrollment
2) Percentage of patients who underwent total prostatectomy as the first treatment for prostate cancer within 6 months of enrollment who had a pathology diagnosis of Non Organ Confined Disease in the resected specimen.
3) Adverse events in patients receiving active treatment
4) Degree of decline in her QOL in patients choosing active surveillance and patients choosing active treatment
5) Overall survival time in patients who selected active surveillance and patients who selected active therapy
6) Metastasis-free survival time in patients who selected active surveillance and patients who selected active therapy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
PSA 20 ng/ml or less, Gleason score 3+3 or less, 2 positive cores or less , and maximum cancer occupancy (within positive cores) less than 50%
Key exclusion criteria
Patients with a history of cerebral infarction, unstable angina, diabetes uncontrolled by insulin, severe hypertension, or myocardial infarction within 6 months
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kakehi |
Organization
Kagawa university
Division name
Department of Urology, Faculty of Medicine
Zip code
761-0793
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa,Japan
TEL
0878912202
yoshiyukikakehi@gmail.com
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Kato |
Organization
Kagawa university
Division name
Department of Urology, Faculty of Medicine
Zip code
761-0793
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa,Japan
TEL
0878912202
Homepage URL
kato.takuma@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kagawa university
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa,Japan
Tel
0878985111
kenkyushien@kagawa-u.ac.jp
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
| 2023 | Year | 11 | Month | 19 | 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
134
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
Completed
Date of protocol fixation
| 2001 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2002 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2002 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 11 | Month | 19 | Day |
Last modified on
| 2023 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060305
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