OncoMatch/Clinical Trials/NCT06807359
Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System
Is NCT06807359 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Photodynamic Therapy (PDT) and Verteporfin for prostate cancer.
Treatment: Photodynamic Therapy (PDT) · Verteporfin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage ORGAN-CONFINED, LOCALIZED
Excluded: Stage III, REGIONAL PELVIC LYMPH NODE METASTASIS, METASTATIC DISEASE
Grade: Gleason Score 7 (3+4 or 4+3) (Gleason)
Histologically confirmed organ-confined adenocarcinoma of the prostate cancer diagnosed within the last 9 months. Gleason Score 7 (3+4 or 4+3). Evidence of locally advanced, regional pelvic lymph node metastasis, or metastatic disease [excluded]. Any suspicious for, probable, or definite extracapsular extension on pretreatment MRI [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radical surgery
Prior radical surgery for carcinoma of the prostate
Cannot have received: pelvic radiation
prior pelvic radiation
Cannot have received: transurethral resection of the prostate
prior TURP
Cannot have received: cryosurgery
prior cryosurgery of the prostate
Cannot have received: brachytherapy
prior treatment with any form of brachytherapy
Cannot have received: androgen deprivation therapy
previous androgen deprivation therapy (ADT)
Cannot have received: chemotherapy
chemotherapy for prostate cancer
Lab requirements
Blood counts
granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3
Kidney function
creatinine ≤ 1.5 mg/dl
Liver function
total bilirubin ≤ 1.5 mg/dl, sgot ≤ 3x uln, alt ≤ 3x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify