Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System (NCT06807359) | Clinical Trial Compass
RecruitingPhase 1/2
Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System
United States, Germany43 participantsStarted 2025-01-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects ≥ 18 years.
✓. Histologically confirmed organ-confined adenocarcinoma of the prostate cancer diagnosed within the last 9 months. Including subjects on active surveillance with evidence of disease progression and a prostate biopsy not older than 9 months.
✓. Gleason Score 7 (3+4 or 4+3).
✓. PSA ≤ 15 ng/mL.
✓. Lesion volume on mpMRI \< 1.5 cm3.
✓. Adequate stage imaging such as pelvic CT/MRI/PET scan within the last 6 months confirming localized cancer.
✓. Treatment target volume \<50 cm3 defined by TRUS or MRI.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion criteria
✕. Evidence of locally advanced, regional pelvic lymph node metastasis, or metastatic disease.
✕. Any suspicious for, probable, or definite extracapsular extension on pretreatment MRI
What they're measuring
1
Safety of treatment
Timeframe: Within 4 weeks of treatment in each cohort.
2
Safety - Damage to the periprostatic tissue mediated by PDT
✕. Contralateral PIRADS 4/5 lesion (even if negative targeted biopsy)
✕. High volume GG1 disease in the contralateral prostate, outside of the ablation zone. High volume is defined as \>1 core of GG1 with a linear amount of carcinoma \>6mm.
✕. Prior radical surgery for carcinoma of the prostate, prior pelvic radiation, prior TURP, prior cryosurgery of the prostate.
✕. Prior treatment with any form of brachytherapy.
✕. Previous androgen deprivation therapy (ADT) or chemotherapy for prostate cancer.