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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023451
Receipt No. 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 2019/08/05

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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
Email 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
Email takahi@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

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
Email 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
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
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027022

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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