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 range
18 Years
Sex
MALE
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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.