None listed
Conditions
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.
Interventions
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,
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.
Sponsors
National Institute of Integrative Medicine
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Healthy volunteers
No
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
Exclusion criteria
Not planning other treatment or medical interventions, e.g. vaccinations during the 3 month trial period. porphyria not able to provide consent
Outcome results
None listed