UMIN-CTR Clinical Trial

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