Actively Recruiting
Open-label Clinical Study to Assess Safety and Efficacy of SpectraCure P18 System and Verteporfin for Injection in Recurrent Prostate Cancer
Led by SpectraCure AB · Updated on 2026-05-01
66
Participants Needed
4
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prostate cancer is one of the most common cancers affecting men, and many men experience a return of the cancer after initial treatment. This research aims to study the safety and effectiveness of a treatment using the SpectraCure P18 System combined with the drug verteporfin for injection (VFI) in men with recurrent prostate cancer. The study focuses on finding appropriate dose levels and understanding how well this treatment works for patients who have already received radiation therapy and have limited treatment options due to recurrence. Participants will receive interstitial photodynamic therapy, where light is delivered to the tumor through optical fibers using the SpectraCure P18 System, along with the drug verteporfin as a photosensitizer. This dose titration study will help determine the safe and effective levels of both the light and drug doses. The treatment is given after confirming local recurrence of prostate cancer following previous radiation therapy. During the study, participants will be monitored closely with laboratory tests, biopsies, and imaging to assess safety and treatment effects. Researchers will track side effects related to the treatment within 4 weeks and evaluate cancer presence through biopsies at 6 months. Additional follow-ups at 12 months will assess tumor status, biochemical markers, and possible spread of disease. The total participation time varies, with close monitoring of treatment safety and effectiveness over the year following therapy.
CONDITIONS
Brief Title
Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- History of external or internal high dose radiation therapy for localized prostate cancer with confirmed local recurrence
- Prostate volume less than 50 cm3 by transrectal ultrasound
- Not eligible for surgery or curative radiotherapy
- ECOG performance status of 0 or 1
- Expected survival of at least 8 months for phase 1, at least 12 months for phase 2
- Sufficient bone marrow reserve (granulocyte count ≥1500/mm3, platelet count ≥100,000/mm3)
- Adequate kidney function (creatinine ≤1.5 mg/dl)
- Adequate liver function (bilirubin ≤1.5 mg/dl, SGOT and ALT ≤3 times upper normal limit)
- Signed informed consent
You will not qualify if you...
- Locally advanced (T3/T4) or metastatic prostate cancer
- Prior seed implantation brachytherapy
- Gleason score ≥8 at initial diagnosis
- Less than 1 week since surgery (except minor procedures)
- Current infection
- Severe concurrent diseases unsuitable for study
- Mental incapacity or psychiatric illness interfering with consent or follow-up
- Contraindications to photosensitizer use
- Porphyria or light-exacerbated diseases
- Known hypersensitivity to verteporfin or related substances
- Tumors eroding major blood vessels near treatment site
- Ongoing therapy with other photosensitizing agents
- Participation in another therapeutic clinical study within 3 months
- History of severe or persistent radiation-induced proctitis
- Contraindications for MRI/Gadolinium contrast (phase 2 only)
- Ongoing or planned hormone therapy (phase 2 only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Within 1 week of treatment
Participants receive interstitial photodynamic therapy using the SpectraCure P18 System combined with the drug verteporfin as a photosensitizer. This treatment is given in a dose titration design to determine the light and drug threshold doses.
1 treatment visit
Duration - Up to 12 months following treatment
Participants are monitored for safety and efficacy outcomes including adverse events, tissue damage, tumor status, and disease progression following treatment.
Multiple follow-up visits including assessments at 5-9 days, 4 weeks, 6 months, and 12 months post-treatment
Trial Site Locations
Total: 4 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
2
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, ON M5G 2M9
Actively Recruiting
3
Skåne University Hospital
Malmö, Skåne County, Sweden
Actively Recruiting
4
Reader in Urology, University College London & Honorary Consultant Urological Surgeon, University College London Hospitals Trust
London, United Kingdom, W1W 7TS
Actively Recruiting
Research Team
J
Johannes Swartling
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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