Study to assess the safety and adequacy of the effectiveness of the SpectraCure P18 System

• Research type

  Research Study

• Full title

  Open-label clinical study to assess the safety and adequacy of the 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

  1005251

• Contact name

  Kristina Holst

• Contact email

  kho@spectracure.com

• Sponsor organisation

  Spectracure

• Eudract number

  2017-004224-30

• Clinicaltrials.gov Identifier

  NCT03067051

• Research summary

  The SpectraCure P18 Study will be open to men diagnosed with localised recurrent prostate cancer after radiation therapy. 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.

  The total study duration is 14 months including a screening period of up to 8 weeks.
  The plan is for six sites in five countries to participate in the trial; 1 site in UK, 1 site in Sweden, 2 sites in Germany 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.

  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).

• REC name

  HSC REC B

• REC reference

  22/NI/0110

• Date of REC Opinion

  16 Sep 2022

• REC opinion

  Further Information Favourable Opinion