UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042253 |
|---|---|
| Receipt number | R000048236 |
| Scientific Title | Impact of androgen deprivation therapy on cognitive function in patients with prostate cancer. |
| Date of disclosure of the study information | 2020/10/27 |
| Last modified on | 2022/11/08 11:30:27 |
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Basic information
Public title
Impact of androgen deprivation therapy on cognitive function in patients with prostate cancer.
Acronym
Impact of androgen deprivation therapy on cognitive function in patients with prostate cancer.
Scientific Title
Impact of androgen deprivation therapy on cognitive function in patients with prostate cancer.
Scientific Title:Acronym
Impact of androgen deprivation therapy on cognitive function in patients with prostate cancer.
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Androgen deprivation therapy (ADT) is effective as a systemic therapy for metastatic prostate cancer or as an in conjunction with radiotherapy for localized disease.
The use of ADT has also been associated with various adverse events as a consequence of testosterone deficiency. Recently, several studies have also examined the impact of ADT on cognitive function. However, these findings are still controversial.
In this study, we prospectively investigated the relationship between ADT and cognitive impairment in patients with PCa.
Basic objectives2
Others
Basic objectives -Others
Primary endopoint: Comparison of the change in cognitive function between patients with prostate cancer treated with androgen deprivation therapy and control group.
Secondary endopoint: Relationship between the change in cognitive function and patients' characteristics.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the change in cognitive function between patients with prostate cancer treated with androgen deprivation therapy and control group.
Key secondary outcomes
Relationship between the change in cognitive function and patients' characteristics.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Prostate cancer group
1.Patients who received androgen deprivation therapy.
2.Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-2.
3.Expected survival is more than 12 months.
4.Patients who understand this research plan and have given their consent.
Control group
1.Patients with suspected prostate cancer who require regular monitoring.
2.Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-2.
3.Expected survival is more than 12 months.
4.Patients who understand this research plan and have given their consent.
Key exclusion criteria
1.Patients with active other malignancy.
2.Patients with or confirmed a history of cognitive impairment.
3.Patients with other serious disease or condition.
4.Patients deemed inappropriate by the attending physician.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Yamamoto |
Organization
Kindai University Nara Hospital
Division name
Department of Urology
Zip code
630-0293
Address
1248-1 Otodacho Ikoma-city, Nara
TEL
074-377-0880
yamamotokindai@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Yamamoto |
Organization
Kindai University Nara Hospital
Division name
Department of Urology
Zip code
630-0293
Address
1248-1 Otodacho Ikoma-city, Nara
TEL
074-377-0880
Homepage URL
yamamotokindai@yahoo.co.jp
Sponsor or person
Institute
Department of Urology, Kindai University Nara Hospital.
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
Kindai University Nara Hospital Certified Review Board
Address
1248-1 Otodacho Ikoma-city, Nara
Tel
074-377-0880
n-rinri@med.kindai.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
| 2020 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000048236&flwp_key=1004IRoXcCd
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000048236&flwp_key=1004IRoXcCd
Number of participants that the trial has enrolled
88
Results
A total of 77 patients completed all scheduled assessments. Serum testosterone levels and MMSE scores were almost identical in the 2 cohorts at baseline. With 36-months follow up, significant decrease on the serum testosterone levels were observed in patients on ADT, but not in controls. As measured by MMSE, no statistically significant differences in cognitive function were observed at 6, 12 and 36 months compared to baseline in either cohort.
Results date posted
| 2022 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Prostate cancer group
1.Patients who received androgen deprivation therapy.
2.Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-2.
3.Expected survival is more than 12 months.
4.Patients who understand this research plan and have given their consent.
Control group
1.Patients with suspected prostate cancer who require regular monitoring.
2.Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-2.
3.Expected survival is more than 12 months.
4.Patients who understand this research plan and have given their consent.
Participant flow
1.Assessing changes in cognitive functioning scores from the baseline to 3 years later.
2.Correlation between the levels of serum testosterone and changes in cognitive function scores.
3.Statistical analysis of correlation with clinical information.
Adverse events
none
Outcome measures
1.Assessing changes in cognitive functioning scores from the baseline to 3 years later.
2.Correlation between the levels of serum testosterone and changes in cognitive function scores.
3.Statistical analysis of correlation with clinical information.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Assessing changes in cognitive functioning scores from the baseline to 3 years later.
2.Correlation between the levels of serum testosterone and changes in cognitive function scores.
3.Statistical analysis of correlation with clinical information.
Management information
Registered date
| 2020 | Year | 10 | Month | 27 | Day |
Last modified on
| 2022 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048236
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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