Actively Recruiting
Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System
Led by SpectraCure AB · Updated on 2026-05-01
66
Participants Needed
4
Research Sites
562 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The rationale for the study is to obtain safety and efficacy data as well as to establish dose parameters for the SpectraCure P18 System with IDOSE®, with verteporfin for injection (VFI) as photosensitizer for the treatment of recurrent prostate cancer.
CONDITIONS
Official 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 over 18 years who received external or internal high dose radiation therapy for localized prostate cancer with confirmed local recurrence
- Prostate volume less than 50 cm3 measured by transrectal ultrasound
- Not eligible for surgery or curative radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 8 months (Phase 1) or 12 months (Phase 2)
- Sufficient bone marrow reserve: granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3
- Adequate kidney function with creatinine ≤ 1.5 mg/dl
- Adequate liver function: total bilirubin ≤ 1.5 mg/dl, SGOT and ALT ≤ 3 times the upper limit of normal
- Signed informed consent
You will not qualify if you...
- Locally advanced (T3/T4), regional lymph node metastasis, or metastatic disease
- Prior treatment with seed implantation brachytherapy
- Gleason score ≥ 8 at initial diagnosis
- Surgery less than 1 week ago (except minimal procedures)
- Current infection
- Severe concurrent disease making study participation inappropriate
- Mental incapacity or psychiatric illness interfering with consent or follow-up
- Contraindications for photosensitizer use
- Porphyria or other light-exacerbated diseases
- Known hypersensitivity to verteporfin or excipients
- Known allergies to porphyrins
- Tumors eroding into major blood vessels near treatment site
- Ongoing therapy with photosensitizing agents
- Participation in another therapeutic clinical study within 3 months prior and during this study
- History of severe or persistent proctitis related to radiation
- 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
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
CONTACT
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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