OncoMatch/Clinical Trials/NCT06807359
Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System
Is NCT06807359 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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 →Frequently asked questions
Is NCT06807359 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radical surgery, pelvic radiation, transurethral resection of the prostate disqualifies patients from enrollment.
What disease stage is eligible?
Stage ORGAN-CONFINED or LOCALIZED is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
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 qualifyRelated pages