Open-label clinical study of safety and assessment of adequacy of effectiveness of the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® software) and verteporfin for injection (VFI) for the treatment of recurrent localized prostate cancer
Short Title: SpectraCure P18 Study
Study number: SPC11-01-110
Following radiotherapy, surgical removal of the prostate is more difficult to do and comes with significant risk of associated side effects. These include urinary incontinence, erectile dysfunction and rectal damage.
Photodynamic therapy (PDT) uses light from a laser to activate a drug which has been injected into the bloodstream, to destroy cancer cells. The procedure is done under general anaesthetic.
The purpose of this research study is to establish the safety and effectiveness of a new system for delivering photodynamic therapy (PDT) for prostate cancer, which is able to monitor the effect of treatment and modify the treatment dose. The study will determine the correct light threshold dose and the lowest effective drug dose. Although the drug Verteporfin is widely used in the treatment of other conditions, this is the first time that it is being used in the treatment of prostate cancer.
PDT is an established therapy for certain types of superficial cancers such as skin cancer. Interstitial photodynamic therapy (IPDT) is a development of this technique for solid and deeper lying cancers such as prostate cancer. The light is delivered to the tumour via optical fibres. The light causes the photosensitizing drug to react with oxygen in the tissue to produce an active form of oxygen which causes cell death in the targeted area. Neither the photosensitizer nor the light or tissue oxygen exert any effect until they are combined.
Sponsor & Funder: Spectracure AB, Sweden
ClinicalTrials.gov Identifier: NCT03067051, https://clinicaltrials.gov/ct2/show/NCT03067051