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Study on the Safety and Effectiveness of SpectraCure P18 System and Verteporfin for Treating Localized Prostate Cancer in Men

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of primary localized prostate cancer. The treatment being tested involves the use of a system called the SpectraCure P18 System along with a medication known as verteporfin. Verteporfin is administered as a powder that is mixed into a solution and given through an infusion into the veins. The purpose of the study is to assess the safety and effectiveness of this treatment combination in targeting and eliminating cancer cells in the prostate.

Participants in the study will receive the treatment, and the researchers will monitor how well the SpectraCure P18 System can deliver and control the necessary light dose to treat the cancer. The study will also determine the safest and most effective light dose by observing responses through MRI scans and any side effects that may occur. The trial will involve regular follow-ups to check the progress of the treatment and to ensure the safety of the participants.

Throughout the study, the effectiveness of the treatment will be evaluated by checking for the absence of cancer cells in the prostate through biopsies at different intervals. The study aims to provide valuable information on whether this combination of the SpectraCure P18 System and verteporfin can be a safe and effective option for treating primary localized prostate cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure all criteria are met.
Step 2
Treatment preparation
Once eligibility is confirmed, preparation for treatment begins. This involves scheduling the administration of the verteporfin medication and planning the use of the SpectraCure P18 System.
Step 3
Medication administration
The medication verteporfin will be administered through an intravenous route. The dosage and frequency will be determined by the study protocol and communicated prior to administration.
Step 4
Light treatment
Following the administration of verteporfin, the SpectraCure P18 System will be used to deliver a controlled light dose to the prostate. This step aims to target and eliminate cancer cells.
Step 5
Post-treatment monitoring
After the treatment, monitoring will occur to assess the immediate effects. This includes MRI scans 5-9 days post-treatment to evaluate any damage to surrounding tissues.
Step 6
Follow-up assessments
Follow-up assessments will be conducted at 6 and 18 months post-treatment. These assessments include biopsies to determine if the treatment was successful in eliminating cancer cells.
Step 7
Final evaluation
A final evaluation will be conducted to assess the overall effectiveness and safety of the treatment. This includes reviewing all collected data and determining the success of the treatment.

Who can join the trial?

18 criteria

Must be a male aged 18 years or older.
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Must have enough healthy bone marrow, shown by:
- Granulocyte count (a type of white blood cell) of at least 1500 per cubic millimeter.
- Platelet count (cells that help blood clot) of at least 100,000 per cubic millimeter.
- Must have good kidney function, shown by a creatinine level of 1.5 mg/dL or less. Creatinine is a waste product in the blood that comes from muscle activity.
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  Must have good liver function, shown by:
  - Total bilirubin (a substance made during the breakdown of red blood cells) of 1.5 mg/dL or less.
  - SGOT (an enzyme found in the liver) level no more than 3 times the upper limit of normal.
  - ALT (an enzyme found in the liver) level no more than 3 times the upper limit of normal.
  - Must sign an informed consent form, which means you understand the study and agree to participate.
  - Must use an effective method of birth control, such as a condom, or have a partner who cannot become pregnant for other reasons.
  - Must have a confirmed diagnosis of prostate cancer that is confined to the prostate and diagnosed within the last 9 months. This includes those under active surveillance with signs of disease progression and a prostate biopsy not older than 9 months.
  - The prostate biopsy should be targeted and systematic, with at least 8 samples taken (4 from the right side and 4 from the left side) and include MRI fusion targeted samples. At least 2 targeted samples are required, but more can be taken if the surgeon decides.
  - Must have a Gleason Score of 7 (3+4 or 4+3). The Gleason Score is a grading system used to evaluate the prognosis of prostate cancer.
  - Must have a PSA (Prostate-Specific Antigen) level of 15 ng/mL or less. PSA is a protein produced by both normal and cancerous prostate cells.
  - The cancer lesion must be less than 1.5 cubic centimeters in volume on a special type of MRI scan called mpMRI.
  - Must have imaging tests like a pelvic CT, MRI, or PET scan within the last 6 months confirming the cancer is localized. A bone scan is optional if PSA is less than 10 ng/mL.
  - The treatment target area must be less than 50 cubic centimeters, as defined by an ultrasound or MRI.
  - Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
  - Must have an expected survival of at least 36 months.

Who cannot join the trial?

3 criteria

Patients with any other type of cancer besides primary localized prostate cancer cannot participate. Primary localized prostate cancer means the cancer is only in the prostate and has not spread to other parts of the body.
Only male patients can participate in this study.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who cannot make decisions for themselves.

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Verified sites

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Rostock University Medical Center
Rostock, Germany
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University Hospital Cologne
Cologne, Germany

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Investigated drugs

Verteporfin is a medication used in this clinical trial to help treat primary localized prostate cancer. It is a type of drug that becomes active when exposed to a specific kind of light. In this study, verteporfin is injected into the body, where it travels to the cancer cells. Once it reaches the cancer cells, a special light is used to activate the medication. This process helps to destroy the cancer cells while minimizing damage to the surrounding healthy tissue.

The SpectraCure P18 System is a therapy device used in this trial to treat prostate cancer. It works by delivering a precise amount of light to the cancer cells in the prostate. This light activates the verteporfin medication, which helps to eliminate the cancer cells. The system is designed to calculate and control the light dose accurately, ensuring that the treatment is both safe and effective. The goal is to target the cancer cells specifically, reducing the risk of side effects and improving the treatment outcome for patients with localized prostate cancer.

What is already known about the treatment

Verteporfin – Verteporfin is administered through an injection and is used in combination with the SpectraCure P18 System, which involves a light-based treatment method. It is currently being studied in clinical trials for its safety and effectiveness in treating primary localized prostate cancer. The main therapeutic use of verteporfin in this context is to help eliminate cancer cells in the prostate. At the molecular level, verteporfin works by being activated by light, which then produces a form of oxygen that can destroy nearby cancer cells. It is classified pharmacologically as a photosensitizing agent, meaning it becomes active when exposed to a specific type of light.

Investigated diseases

Primary localized prostate cancer – Primary localized prostate cancer is a condition where cancer cells form in the tissues of the prostate gland, which is located below the bladder in men. This type of cancer is confined to the prostate and has not spread to other parts of the body. It often progresses slowly and may not cause symptoms in its early stages. As the disease advances, it can lead to urinary difficulties, such as increased frequency or difficulty in urination. The cancer cells can grow and form a tumor, which may eventually affect the function of the prostate and surrounding tissues. Monitoring the progression of the disease is crucial to manage its impact on health.