UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023451 |
|---|---|
| Receipt number | R000027022 |
| Scientific Title | Efficacy and safety of greenpropolis against prostate cancer with biochemical recurrence after radical prostatectomy |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2021/06/15 17:53:34 |
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Basic information
Public title
Efficacy and safety of greenpropolis against prostate cancer with biochemical recurrence after radical prostatectomy
Acronym
Clinical trial of greenpropolis against prostate cancer
Scientific Title
Efficacy and safety of greenpropolis against prostate cancer with biochemical recurrence after radical prostatectomy
Scientific Title:Acronym
Clinical trial of greenpropolis against prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of greenpropolis against prostate cancer with biochemical recurrence after radical prostatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
PSA response rate
Key secondary outcomes
PSA response duration
time to PSA progression
PSA slope before and after administration of propolis
Changes of serum testosterone level
IHC of AKR1C3, AR, and ERG of prostatectomy specimens
QOL
Proportion of adverse events
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
| Food |
Interventions/Control_1
Oral administration of three soft capsules of greenpropolis between or before meals three times a day for 6 months
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male
Key inclusion criteria
Adults younger than 85 years, histologically confirmed adenocarcinoma of the prostate cancer with PSA recurrence (PSA>= 0.2 ng/ml, 2 rising PSA tests with >= at least 2-week interval between each determination ) after radical prostatectomy including patients after salvage radiation therapy to prostatic bed; no prior or present evidence of metastatic disease; ECOG 0~2; no surgery or radiation allowed within 4 weeks before day 1.
Key exclusion criteria
Previously treated or currently be receiving hormonal therapy with the intent to treat prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists or antagonists, anti-androgens or estrogens); Evidence of administration of greenpropolis or other alternative therapies within 3 months before day 1. History of allergy against honey, a coniferous tree, a poplar, Peru balsam, and salicylic acid; History of atopic dermatitis, chronic recurrent eczema, and asthma.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ogawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Urology
Zip code
6068507
Address
54 Kawaharacho Shogoin Sakyoku Kyoto
TEL
075-751-3337
ogawao@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Inoue |
Organization
Kyoto University Graduate School of Medicine
Division name
Urology
Zip code
6068507
Address
54 Kawaharacho Shogoin Sakyoku Kyoto
TEL
075-751-3337
Homepage URL
takahi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine and Kyot University Hospital Ethics Committe
Address
Konoe Yoshida Sakyoku Kyoto Japan
Tel
0757534642
ethcom@kuhp.kyoto-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
| 2016 | Year | 10 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 11 | 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
Management information
Registered date
| 2016 | Year | 08 | Month | 02 | Day |
Last modified on
| 2021 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027022
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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