Clinical study

Clinical study for treatment of prostate cancer

SpectraCure has developed a new method for treatment of recurrent prostate cancer. The goal of the treatment is to eliminate cancer while minimising side effects. Currently, treatment of recurrent prostate cancer after radiation therapy is controversial due to the serious side effects associated with several methods.


After many years of development, we are conducting a clinical study on patients with recurrent prostate cancer after radiation therapy. The study is conducted at leading prostate cancer clinics: Princess Margaret Cancer Centre in Toronto, University College London Hospital, Memorial Sloan Kettering Cancer Center in New York, and Skåne University Hospital in Malmö.


We aim to run the study at clinics at the forefront of prostate cancer treatment.

London

New York

Toronto

Malmö

Further development of a successful therapy

The treatment evaluated in the study is called interstitial photodynamic therapy (PDT). It is a further development of traditional PDT, a treatment successfully used for treatment of certain types of skin cancer. With PDT, the tissue is made light sensitive using a medication, which is activated with laser light to create a reaction that eliminates the tumour cells.


The procedure is performed using SpectraCure’s Q-PRO® system, which delivers light via optical fibers inserted into the prostate. The medication, verteporfin, has been used for many years in clinical practice and is approved for treating eye diseases.

How does the SpectraCure system work?

SpectraCure’s Q-PRO® system includes a laser device and a software called IDOSE ®, which calculates the light dose to be delivered to the prostate. The light dose is adjusted continuously during the treatment to achieve an adequate dose to the entire tumour. The light dose is adjusted to eliminate the cancer cells and at the same time spare healthy surrounding tissue.


Treating cancer tumours with a light-activated medication and light is an established method, but treating tumours inside the prostate with individualised dosimetry is novel.

Objectives of the study
The aim of our study is to investigate the effect of the treatment, to determine the optimal dose of laser light and medication, and to investigate the safety of the system in combination with the medication verteporfin.
 Who can participate?

Patients who:

  • have recurrent prostate cancer
  • have previously been treated with radiation therapy
  • have cancer that has not spread to other parts of the body

The study´s three parts:

  1. Screening and enrolment
  2. Single-session treatment – Interstitial PDT
  3. 12-month follow-up
What treatments are offered to patients with recurrent prostate cancer today?

Several types of treatments are offered to patients with recurrent prostate cancer. Some patients are offered surgery, where the entire prostate is removed. This treatment can cause several side effects. Other treatment alternatives for recurrent prostate cancer include, for example, heat treatment of prostate tissue using high-intensity focused ultrasound (HIFU), or freezing of prostate tissue, cryotherapy. These treatments are performed by specialists at certain clinics and are suitable for some patients. Hormone therapy to block testosterone, androgen deprivation therapy (ADT), is also a treatment alternative. Many doctors choose to delay hormone therapy due to its side effects. Sometimes, the doctor together with the patient decides not to actively treat the cancer but monitor progression.

SpectraCure’s clinical study follows the international standard for clinical studies; Good Clinical Practice (GCP and ISO 14155), and ethical guidelines set by WHO. The guidelines ensure that data and results are accurate and that the rights and privacy of participants are protected.

The clinical study is approved by regulatory authorities in the United Kingdom, Canada, Sweden, and the United States, as well as by ethical committees in each territory.


The participating hospitals are responsible for patient recruitment and assessing the eligibility of participants. Please contact your responsible physician if you are interested in participating in our clinical study.