Actively Recruiting
Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System
Led by SpectraCure AB · Updated on 2026-05-01
43
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to obtain safety data, establish dose parameters, and effectiveness of treatment for the SpectraCure P18 System with IDOSE®, together with verteporfin for injection (VFI) as photosensitizer, for the treatment of primary localized prostate cancer. The study will be divided into two parts, with Phase I, dose-escalation, to study safety and establish an effective light dose, followed by Phase II, cohort expansion, to evaluate clinical efficacy and confirm safety/tolerability. The subjects will be followed for a period of 18 months to determine the primary outcome. The long-term follow-up is an additional 18 months, i.e. a total of 36 months. Interstitial Photodynamic Therapy (PDT) will be performed during general anesthesia. Optical fibers will be inserted into the prostate with a transperineal approach using transrectal ultrasound guidance. The intent is to deliver an adequate light dose throughout the prostate. Subjects will receive VFI intravenously, approximately 60-90 minutes prior to light delivery.
CONDITIONS
Official Title
Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged 18 years or older
- Histologically confirmed organ-confined adenocarcinoma of the prostate diagnosed within the last 9 months
- Subjects on active surveillance with evidence of disease progression and biopsy not older than 9 months
- Prostate biopsy including a minimum of 8 systematic cores and at least 2 targeted cores
- Gleason Score of 7 (3+4 or 4+3)
- PSA level less than or equal to 15 ng/mL
- Lesion volume on mpMRI less than 1.5 cm3
- Adequate stage imaging within the last 6 months confirming localized cancer
- Treatment target volume less than 50 cm3 defined by TRUS or MRI
- ECOG performance status of 0 or 1
- Expected survival of at least 36 months
- Sufficient bone marrow reserve with granulocyte count ≥ 1500/mm3 and platelet count ≥ 100,000/mm3
- Adequate renal function with creatinine ≤ 1.5 mg/dl
- Adequate hepatic function with total bilirubin ≤ 1.5 mg/dl and SGOT and ALT ≤ 3 times upper limit of normal
- Signed informed consent
You will not qualify if you...
- Evidence of locally advanced, regional pelvic lymph node metastasis, or metastatic disease
- Suspicion or confirmation of extracapsular extension on pretreatment MRI
- Contralateral PIRADS 4/5 lesion even if biopsy negative
- High volume GG1 disease in contralateral prostate outside ablation zone
- Prior radical prostate surgery, pelvic radiation, TURP, or cryosurgery
- Prior brachytherapy treatment
- Previous androgen deprivation therapy or chemotherapy for prostate cancer
- Prior or current bleeding disorders
- Tumors eroding into major blood vessels near illumination site
- Use of alpha-reductase inhibitors within 90 days before enrollment
- Serious active medical conditions, psychiatric illness, uncontrolled infections, or other conditions preventing participation
- Mental incapacity or psychiatric illness affecting consent or follow-up
- Contraindications for photosensitizer including porphyria or hypersensitivity to verteporfin or porphyrins
- Ongoing therapy with photosensitizing agents
- Participation in another therapeutic clinical study within 3 months prior and during this study
- Contraindications for MRI or gadolinium contrast such as implants, severe renal impairment, or prior contrast reactions
- Known hypersensitivity to pancuronium bromide, atricurium, or cisatricurium
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
2
Klinik für Urologie, Universitätsklinikum Köln
Cologne, Germany, 50937
Actively Recruiting
3
Klinik und Poliklinik für Urologie, Universitätsmedizin Rostock
Rostock, Germany
Actively Recruiting
Research Team
K
Kristina Holst
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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