Clinical trial of greenpropolis against prostate cancer
- Conditions
- Prostate cancer
- Registration Number
- JPRN-jRCTs051180049
- Lead Sponsor
- Kobayashi Takashi
- Brief Summary
There was no significant anticancer response in patients who received Brazilian green propolis for biochemical recurrence after radical prostatectomy. However, the PSA slope was decreased after propolis administration. Further, Brazilian green propolis may be safely consumed by patients without any related allergies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 22
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PSA response rate
- Secondary Outcome Measures
Name Time Method PSA response duration <br>time to PSA progression <br>PSA slope before and after administration of propolis <br>Changes of serum testosterone level <br>IHC of AKR1C3, AR, and ERG of prostatectomy specimens <br>QOL <br>Proportion of adverse events