SpectraCure P18 Study
Research type
Research Study
Full title
Open-label clinical study to assess the safety and 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 prostate cancer.
IRAS ID
238756
Contact name
Johannes Swartling
Contact email
Sponsor organisation
SpectraCure AB
Eudract number
2017-004224-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
The SpectraCure P18 Study will be open to men diagnosed with localised recurrent prostate cancer. Interstitial photodynamic therapy (IPDT) together with the SpectraCure P18 System and Verteporfin have the potential to be new procedure with minimal side effects for men with localised recurrent prostate cancer.
Interstitial PDT will be performed during general anaesthesia. Optical fibres for light sources and detectors will be inserted in the prostate with a transperineal approach using transrectal ultrasound guidance. The intent is to deliver an adequate light dose throughout the prostate. Subjects will receive verteporfin for injection (VFI) intravenously (i.v.) approximately 60-90 minutes prior to light delivery. The men will be followed for 12 months after IPDT.
The purpose of this research study is to establish the safety and effectiveness of the SpectraCure P18 System and Verteporfin for the treatment of recurrent prostate cancer. The study will determine the correct light threshold dose and the lowest effective drug dose. Interstitial photodynamic therapy (IPDT) with the SpectraCure P18 System (with IDOSE®) and Verteporfin for Injection (VFI) has the potential to be a new procedure with minimal side effects for men with localised recurrent prostate cancer.
The total study duration is 14 months including a screening period of up to 8 weeks.
The plan is for three sites in three countries to participate in the trial; 1 site in UK and 2 in North America (Canada & USA). The sites are all highly-specialised research clinics, with the required resources and experience needed for the study.
12-36 patients will participate in the trial. To date, three patients have been enrolled.
The study will be conducted as a dose titration study to determine the light and drug threshold dose using the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI). Accelerated titration: For the three lowest dose levels, escalation to the next dose level will occur in accelerated form with one subject per dose level if and only if there is no acute toxicity of CTCAE 4.0 grade 2 or greater (within 28 days of treatment), regardless of attribution.REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/0140
Date of REC Opinion
4 Apr 2018
REC opinion
Further Information Favourable Opinion