The effects of a herbal medicine combination in men with biochemically recurrent prostate cancer
Phase 2
- Conditions
- Prostate cancerCancer - ProstateAlternative and Complementary Medicine - Herbal remedies
- Registration Number
- ACTRN12614000901606
- Lead Sponsor
- niversity of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
Biochemically-recurrent prostate cancer, PSA nadir + 2 ng/mL, and a moderate PSA rise (PSA doubling time of 3 - 12 months) in men previously treated for histologically confirmed prostatic cancer with localised therapy.
Exclusion Criteria
* clinical suspicion or evidence of metastastic disease
* atypical prostate carcinoma histology (eg small cell, adenoid cystic)
* hypogonadal men (eg primary testicular failure; pituitary tumour)
* concurrent chemotherapy
* prior cytotoxic chemotherapy or androgen ablative therapy for recurrent disease
* currently receiving biological response modifiers, or high dose prednisolone (50 mg/day or more)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility and safety of a fully-powered randomised controlled trial:<br>* Recruitment and attrition rates, compliance with study procedures, number remaining on active surveillance at three months and after a further three month non-treatment follow-up<br>* Adherence to intervention<br>* Completion of surveys<br>* Compliance with maintaining dietary intake of trial foods: Food Frequency Questionnaire, the Dietary Questionnaire for Epidemiological Studies (DQES)”, Anti-Cancer Council, Victoria.<br>* Safety measures: LFTs; U&Es; FBG & INR (where relevant); record of any symptom relating to tolerance<br>*Side-effects of the interventions<br>[Three months]
- Secondary Outcome Measures
Name Time Method PSA doubling time<br>Serum PSA measured at baseline and end-of treatment [Three months]