UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016371 |
|---|---|
| Receipt number | R000019013 |
| Scientific Title | Long-term analysis of QOL in patients with prostate cancer treated with various hormone therapy |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2022/02/03 10:13:00 |
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Basic information
Public title
Long-term analysis of QOL in patients with prostate cancer treated with various hormone therapy
Acronym
Hormone therapy and QOL in prostate cancer
Scientific Title
Long-term analysis of QOL in patients with prostate cancer treated with various hormone therapy
Scientific Title:Acronym
Hormone therapy and QOL in prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long term trend of quality of life in prostate cancer patients treated with hormonal therapy both in primary therapy and castration resistant stage.
Basic objectives2
Others
Basic objectives -Others
To evaluate the long term trend of bone related events, body composition and various hormone levels.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of QOL score trend in intra-treatment and inter-treatment.
Key secondary outcomes
Changes of bone mineral density, bone metabolic marker, fat mass, lean mass and hormone levels.
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
1) male age >20 yo =20yo
2) histologially proven prostate cancer
3) patients supposed to be treated with hormone therapy or those treated with hormone therapy
4)both hormone sensitive and castration-resistant state
5) obtained written informed consent
Key exclusion criteria
1)disablity of QOL assessment by patients or family members
2) other conditions in which physicians considers
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Urology
Zip code
3718511
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8300
kazu@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Urology
Zip code
3718511
Address
-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8300
Homepage URL
kazu@gunma-u.ac.jp
Sponsor or person
Institute
Department of Urology, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japanese Fundation for Prostate Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, mebashi,Gunma,
Tel
027-220-8740
gunmaciru-office@umin.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
| 2015 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
No specific URL
Publication of results
Unpublished
Result
URL related to results and publications
No specific URL
Number of participants that the trial has enrolled
41
Results
In progressive stages, QoL scores at enrollment were significantlry low in comparison with local or locally advanced stages. Especially, this tendency was prominent in urinary, hormone domains. Hormone naive patients group showed significant higher scores in hormone domains, and significant lower scores in sexual bother domain. In this group, scores in urinary domain were improved adn hormone function and hormone domain were getting worse.
Results date posted
| 2022 | Year | 02 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty one patients were recruited. Ages ranged from 53-75 years with median 75 years. PSA levels ranged from 3.94 to 2149.9 ng/mlwith 18.13ng/ml. Gleason scores are 6 in 1 pt, 7 in 8pts, 8 in 18pts, and 10 in 2pts. Clinical stages were II in 10 pts, III in 6pts, and IV in 16pts. Patients were treated with LHRH agonist or antagonists with/without biculatamide.
Participant flow
Enrolled time varied: untreated time in 21 pts, within 3mo in 8pts, 3 to 12 mo in 6pts, and longer than 12mo in 6pts.
Adverse events
No severe adverse events were observed in related to hormone treatment.
Outcome measures
QOL assessment was performed using fACT-P and EPIC questionaires with 6 months inverval. In EPIC, scores in each domain were evaluated. In FACT-P, scores in each domain and total scores were evaluated. Variables were treatment duration at enrollent, and clinical stages.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Durign primary hormone therapy:every 6 months
After castration-resistant stage: every 12 weeks
Management information
Registered date
| 2015 | Year | 01 | Month | 29 | Day |
Last modified on
| 2022 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019013
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