Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000633886
Ethics application status
Approved
Date submitted
26/03/2021
Date registered
27/05/2021
Date last updated
27/05/2022
Date data sharing statement initially provided
27/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Photodynamic Therapy (PDT) on Prostate Cancer
Scientific title
Assessing the effectiveness of photo-dynamic therapy (PDT) for local prostate cancer by imaging, urinary proteomics and Circulating Tumour Cell (CTC) analysis, a randomized 3-month trial
Secondary ID [1] 303803 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 321319 0
Condition category
Condition code
Cancer 319111 319111 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Men with prostate cancer will undergo 6 cycles of Photodynamic Therapy (PDT) over 9 weeks. Each PDT cycle consists of 2 steps. Step 1: oral administration of 10 ml photosensitizer fluid containing 9.5mg of a chlorophyll-derivate extracted from algae, Step2: followed by 25 min of 630-650 nm laser therapy 15-20 hours after dosing. The treatment schedule consists of 2x cycles on 2 consecutive days (Mon, Tue), followed by a 4 week interval.
The photosensitizer is a chlorophyll derivative from algae, registered as a food product with the TGA.
The local laser therapy will be delivered via a rectal probe directly to the prostate.
A proportion of patients will be randomized to receive additional whole body lightbed laser therapy of 460 nm (blue) and 660 nm (red light) for 25 min, on the same day 4 hours after local PDT treatment.
SMS reminders will be sent to participants to assist with adherence to protocol.
Intervention code [1] 320119 0
Treatment: Devices
Comparator / control treatment
Primary comparator: Patients are their own control in both groups (PDT and PDT + light bed group). Treatment effectiveness will be assessed by a number of tests done before compared to after treatment. Tests include assessment of prostate volume by photography, Circulating Tumour Cell (CTC) count by blood test, and urinary proteomics.
Secondary comparator: Randomisation of patients receiving PDT or PDT + light bed therapy. CTC count change in patients after receiving only PDT treatment will be the reference comparator to CTC count change in patients receiving PDT + light bed therapy.
Control group
Active

Outcomes
Primary outcome [1] 326997 0
Number of CTC / CTC count by cytology
Timepoint [1] 326997 0
at time of blood draw: 12 weeks compared to baseline
Primary outcome [2] 326998 0
urinary proteomics - exploratory:
previous pilot study found a total of 462 peptides, corresponding to 86 unique proteins
Timepoint [2] 326998 0
12 weeks compared to baseline
Secondary outcome [1] 393415 0
prostate volume by fluorescent photography
Timepoint [1] 393415 0
12 weeks compared to baseline
Secondary outcome [2] 394594 0
safety & tolerability will be assessed by questionnaire, including the International Prostate Symptom Score (IPSS) and our standard research side effects & tolerability questionnaire
Timepoint [2] 394594 0
At and after each of the 6 treatments (2 treatments/ wk x 3 spread over 9 weeks)

Eligibility
Key inclusion criteria
Group A: Men with biopsy proven primary prostate cancer, or local prostate cancer relapse after treatment
Group B: Men with primary prostate cancer, diagnosed by PSMA-PET or MRI scan
Group C: Men with metastatic prostate cancer
Minimum age
50 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Not planning other treatment or medical interventions, e.g. vaccinations during the 3 month trial period.
porphyria
not able to provide consent

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)
Not possible
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomized number generation
to treatment group 1: PDT (n=50)
treatment group 2: PDT + lightbed (n=25)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size
A sample size of 75 participants (n=50+25) was based on Phase 1 safety study including 37 participants with primary local prostate cancer or relapse.
Using the CTC count before and after treatment in this study will provide additional insights into treatment effectiveness.

Analysis
Analyses will be performed using SPSS (PASW version 26). Statistical significance will be set at p<0.05. Continuous variables will be analysed between groups by student t-test and analysis-of-covariance (ANCOVA), and categorical variables will be analysed by Chi-square test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
21/06/2021
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
75
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 33576 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 308201 0
Commercial sector/Industry
Name [1] 308201 0
RMWC Unlimited Innovation P/L
Country [1] 308201 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Institute of Integrative Medicine
Address
21 Burwood Rd
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 308982 0
None
Name [1] 308982 0
Address [1] 308982 0
Country [1] 308982 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308182 0
National Institute of Integrative Medicine HREC
Ethics committee address [1] 308182 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Ethics committee country [1] 308182 0
Australia
Date submitted for ethics approval [1] 308182 0
26/03/2021
Approval date [1] 308182 0
26/05/2021
Ethics approval number [1] 308182 0
0087N_2021

Summary
Brief summary
Prostate cancer is the most common cancer in men, and the second leading cause of cancer deaths (25%) in Australia. There is a need for better treatment combined with reliable assessments of treatment effectiveness.

The purpose of this study is to determine whether Photodynamic Therapy (PDT) is an effective and safe treatment option for patients with prostate cancer.

Who is it for?
You may be eligible for this study if you are an adult male with prostate cancer.

Study details
Participants in this study will receive one of two treatments, with the treatment decided by chance. The two treatments participants may receive are:
1. Photodynamic Therapy, which involves participants being given a chlorophyll-derived liquid food product which will help absorb light along with 25 min light therapy using a red-light laser that is delivered through a rectal probe.
2. The Photodynamic Therapy described above plus additional whole body red-light therapy, which involves lying in a red-light-bed for 25 min 4 hours after the PDT rectal laser therapy.
These treatments will be provided to participants 6 times over a 9 week period.

Participants will complete an assessment at baseline and at 12 weeks where they will provide a blood and urine sample, and have their prostate measured.

It is hoped that this research will help determine whether Photodynamic Therapy is an effective and safe option for the treatment of prostate cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109834 0
A/Prof Karin Ried
Address 109834 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 109834 0
Australia
Phone 109834 0
+61 03 9912 9545
Fax 109834 0
Email 109834 0
[email protected]
Contact person for public queries
Name 109835 0
A/Prof Karin Ried
Address 109835 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 109835 0
Australia
Phone 109835 0
+61 03 9912 9545
Fax 109835 0
Email 109835 0
[email protected]
Contact person for scientific queries
Name 109836 0
A/Prof Karin Ried
Address 109836 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 109836 0
Australia
Phone 109836 0
+61 03 9912 9545
Fax 109836 0
Email 109836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only summary data will be available. Due to privacy reasons, no individual data will be shared publicly. Individual data will be shared with the patient's doctor.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.