Clinical trial of greenpropolis against prostate cancer

JRCT ID: jRCTs051180049

Registered date:05/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 08/12/2016
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Oral administration of three soft capsules of greenpropolis between or before meals three times a day for 6 months

Outcome(s)

• Primary Outcome: PSA response rate

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 84age old
• Gender: Male
• Include 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.
• Exclude 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

Related Information

• Primary Sponsor: Kobayashi Takashi
• Source(s) of Monetary Support: Japan society for the Promotion of Science