Clinical Trial Toronto

Clinical study for recurrent prostate cancer after radiotherapy

Study ID: SPC11-01-110

The study evaluates a new intervention as a treatment option for localized recurrent prostate cancer, available at Princess Margaret Cancer Centre in Toronto. The goal of the intervention is to eliminate cancer cells with few side effects.

Where: Princess Margaret Cancer Centre in Canada (Toronto)

About the study intervention in Toronto

The study intervention, called interstitial photodymanic therapy (PDT), is a local and minimally invasive procedure that utilizes light and a pharmaceutical to eliminate cancer cells in a specific area. The pharmaceutical is given to make the tissue sensitive to light. Small instruments (a few millimeters in diameter) are inserted into the prostate and the tumor to create local cell death while sparing surrounding tissue to reduce side effects.

Today, PDT is used to treat bladder cancer and skin cancer for example.

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Who can participate in the study?

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

If you want to participate in the study

Each study site is responsible for the recruitment and selection of participants. Contact your treating physician if you are interested in this clinical study. Your doctor will know if the study may be an alternative for you and answer questions you may have about your diagnosis or other options.

Where is the clinical study conducted?

The study is performed at clinics in Europe and North America:

Princess Margaret Cancer Centre in Canada (Toronto)

University College London Hospital in the UK (London)

Memorial Sloan Kettering Cancer Center in the US (New York)

Skåne University Hospital in Sweden (Malmö)

The study consists of three parts:

1. Screening process – selection of participants.

2. Study intervention – the interstitial PDT procedure is performed once.

3. Follow-up – your well-being and prostate cancer will be monitored for 12 months.

Background

Following a prostate cancer treatment, the patient’s PSA levels (a blood test for prostate cancer) are closely monitored to detect potential recurrence. The optimal management of recurrent prostate cancer after radiotherapy is still unclear(1). This clinical study investigates a new option for patients with recurrent prostate cancer.

Objectives of the study

The study aims to investigate the safety and efficacy of a new medical device together with the drug verteporfin, and to determine the most effective drug and light dose.

For more study information

Press here if you want to know more about the study in Toronto. 

A new medical device

The medical device used for the study procedure consists of hardware that delivers light and software that performs different measurements and calculations to increase the effect inside the tumor while sparing surrounding tissue. The drug used for the study intervention is already approved for the treatment of eye diseases.

What is a clinical study?

The purpose of a clinical study is to learn more about an intervention before it becomes available to the public. Information learned from a study can be used to understand the effects of a particular procedure better and may help patients with similar conditions in the future.

Responsible for the study

SpectraCure is the responsible sponsor of the study as part of their work to develop a new medical device for the treatment of solid cancer tumors.

(1) Valle, L. F., Lehrer, E. J., Markovic, D., Elashoff, D., Levin-Epstein, R., Karnes, R. J., Reiter, R. E., Rettig, M., Calais, J., Nickols, N. G., Dess, R. T., Spratt, D. E., Steinberg, M. L., Nguyen, P. L., Davis, B. J., Zaorsky, N. G., & Kishan, A. U. (2021). A Systematic Review and Meta-analysis of Local Salvage Therapies After Radiotherapy for Prostate Cancer (MASTER). European urology, 80(3), 280–292. https://doi.org/10.1016/j.eururo.2020.11.010