The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Trial ID
ACTRN12614000901606
Ethics application status
Approved
Date submitted
14/08/2014
Date registered
25/08/2014
Date last updated
25/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a herbal medicine combination in men with biochemically recurrent prostate cancer
Scientific title
The PC-PRoC Trial – The effects of a phyotherapeutic (herbal medicine) combination on PSA doubling time in men with biochemically recurrent prostate cancer


Secondary ID [1] 285154 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PC-ProC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 292740 0
Condition category
Condition code
Cancer 293034 293034 0 0
Prostate
Alternative and Complementary Medicine 293111 293111 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A tablet/capsule combination of four (4) phytotherapeutic/herbal agents:
A tablet combination of green tea (Camellia sinensis) standardised to contain green tea catechins 100 mg, turmeric (Curcuma longa) standardised to contain curcumin 100 mg, resveratrol (from Polygonum cuspidatum); 30 mg; and broccoli sprout extract (Brassica oleracea) 100 mg in capsule form. The proposed dose is two tablets and two capsules to be taken orally daily for twelve weeks.
Drug tablet/capsule return will be used to monitor compliance.

Intervention code [1] 290000 0
Treatment: Drugs
Comparator / control treatment
Identical placebo tablets containing microcrystalline cellulose, calcium hydrogen phosphate, magnesium stearate, hypromellose, coloured coated to mask appearance containing iron oxide. 2 tablets twice daily.
Identical placebo capsules contain milled green oats. 2 capsules twice daily.
Control group
Placebo

Outcomes
Primary outcome [1] 292899 0
Feasibility and safety of a fully-powered randomised controlled trial:
* 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
* Adherence to intervention
* Completion of surveys
* Compliance with maintaining dietary intake of trial foods: Food Frequency Questionnaire, the “Dietary Questionnaire for Epidemiological Studies (DQES)”, Anti-Cancer Council, Victoria.
* Safety measures: LFTs; U&Es; FBG & INR (where relevant); record of any symptom relating to tolerance
*Side-effects of the interventions
Timepoint [1] 292899 0
Three months
Secondary outcome [1] 309893 0
PSA doubling time
Serum PSA measured at baseline and end-of treatment
Timepoint [1] 309893 0
Three months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potentially eligible patients are provided with a Participant Information and Consent Form, and given pathology request forms for blood tests during routine visit to oncologist.
Once blood test results are available, trial coordinator contacts patient by telephone. If willing to proceed, patients are screened, and appointment made for another visit with oncologist, followed by trial coordinator.
Oncologist completes Karnofsky assessment, consents men and gives prescription for trial “herbs/placebo”.
Patient is assigned the next available study identification number, and given the questionnaires/instructions how to access questionnaires online. Patient is then taken to pharmacist, who dispenses tablets according to the randomisation code sent to her by statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule has been produced by a statistician at the NHMRC Clinical Trials Centre using a reproducible permuted block method.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Pilot study to assess feasibility/accrual rates, as well as safety and efficacy
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The data obtained in this phase II study will be used to inform the selection of definitive power calculations and secondary endpoints for a future phase III trial. No statistical difference between groups on clinical outcomes is expected in this pilot study.
Standard descriptive statistics will be prepared for categorical and continuous variables. Appropriate measures of effect will be calculated with two-sided 95% confidence intervals. Generalised linear modelling methods will be used to evaluate treatment effects adjusted for baseline values (where applicable) and will also be used to investigate the sensitivity of estimates to adjustment for other relevant covariates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2834 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment postcode(s) [1] 8524 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 289754 0
University
Name [1] 289754 0
University of Melbourne
Address [1] 289754 0
Department of General Practice
200 Berkeley Street
CARLTON 3053
VIC
Country [1] 289754 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Department of General Practice
200 Berkeley Street
CARLTON 3053
VIC
Country
Australia
Secondary sponsor category [1] 288444 0
Hospital
Name [1] 288444 0
Peter MacCallum Cancer Centre
Address [1] 288444 0
St Andrew’s Place
East Melbourne, 3002
VIC
Country [1] 288444 0
Australia
Other collaborator category [1] 278082 0
University
Name [1] 278082 0
NHMRC Clinical Trials Centre
University of Sydney
Address [1] 278082 0
Locked Bag 77
Camperdown NSW 1450
Country [1] 278082 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291488 0
Peter Mac Human Research Ethics Committee
Ethics committee address [1] 291488 0
Peter MacCallum Cancer Centre
St Andrew’s Place
East Melbourne, 3002
VIC
Ethics committee country [1] 291488 0
Australia
Date submitted for ethics approval [1] 291488 0
Approval date [1] 291488 0
12/06/2014
Ethics approval number [1] 291488 0
13/149
Ethics committee name [2] 291489 0
University of Melbourne Health Sciences Human Ethics Sub-committee
Ethics committee address [2] 291489 0
Level 1, 780 Elizabeth Street
(University Building No. 220)
Melbourne VIC 3010
Ethics committee country [2] 291489 0
Australia
Date submitted for ethics approval [2] 291489 0
Approval date [2] 291489 0
08/08/2014
Ethics approval number [2] 291489 0
1442382

Summary
Brief summary
This research study is looking at a combination of four herbs, which are common components of a healthy diet, in men who have been treated for prostate cancer, and have rising prostate specific antigen (PSA).
Who is it for?
You may be eligible to join this study if you are a male aged 18 years or above whose PSA is rising at a slow or moderate rate after surgery or radiotherapy for prostate cancer (referred to as 'biochemically recurrent prostate cancer').
Study details
Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will take a combination of tablets and capsules containing green tea (Camellia sinensis), turmeric (Curcuma longa), resveratrol (which commonly occurs in grapes and wine) from giant knotweed (Polygonum cuspidatum) and broccoli sprout extract (Brassica oleracea). All of these are readily available over-the-counter in herbal combination products, and have all been tested in humans before. Participants in the other group will instead receive a placebo (inactive treatment). All participants will be asked to take two tablets and two capsules twice daily for 12 weeks.
Participants will not know to which group they have been allocated until after the study is completed. Participants will have their PSA doubling time assessed at 3 months to determine any effect of treatment. It is thought that the natural herbal treatments may slow the rate at which PSA rises, and may also help to reduce any lingering side-effects following treatment, and improve quality of life. This is an initial small (pilot) study that may form the basis of a larger trial in the future.
Trial website
Trial related presentations / publications
Pirotta, M., van Die, MD., Emery, J., Williams, S. Effect of phytotherapeutic supplementation in men with biochemically recurrent prostate cancer – a pilot study. PC4 concept development workshop, Melbourne, 17 Sept 2013
Emery, J., van Die, MD., Pirotta, M., Martin, A., Williams, S. Effect of a phytotherapeutic combination in men with biochemically recurrent prostate cancer. ANZUP concept development workshop, Melbourne, 15 July 2014
Van Die MD, Bone KM, Williams SG, Pirotta MV. Soy and soy isoflavones inprostate cancer: a systematic review and meta-analysis of randomized controlledtrials. BJU Int. 2014;113(5b):E119-30. doi: 10.1111/bju.12435
Public notes

Contacts
Principal investigator
Name 50638 0
Prof Jon Emery
Address 50638 0
The University of Melbourne
Department of General Practice
200 Berkeley Street
CARLTON 3053
VIC

Country 50638 0
Australia
Phone 50638 0
+613 9035 8018
Fax 50638 0
+613 9347 6136
Email 50638 0
jon.emery@unimelb.edu.au
Contact person for public queries
Name 50639 0
Dr Diana van Die
Address 50639 0
The University of Melbourne
Department of General Practice
200 Berkeley Street
CARLTON 3053
VIC
Country 50639 0
Australia
Phone 50639 0
+613 8344 7276
Fax 50639 0
+613 9347 6136
Email 50639 0
mvandie@unimelb.edu.au
Contact person for scientific queries
Name 50640 0
Dr Diana van Die
Address 50640 0
The University of Melbourne
Department of General Practice
200 Berkeley Street
CARLTON 3053
VIC
Country 50640 0
Australia
Phone 50640 0
+613 8344 7276
Fax 50640 0
+613 9347 6136
Email 50640 0
mvandie@unimelb.edu.au