NCT06807359 · SpectraCure AB
Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System
What this study 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.
View original scientific description
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.
Interventions
DEVICE
Photodynamic Therapy (PDT)
The PDT treatment is provided with the SpectraCure P18 laser light delivery system. 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. The photosensitizer is activated with light of a specific wavelength that is delivered to the tumor via optical fibers. The activated photosensitizer reacts with oxygen to form highly toxic radicals which induce cell death in the tumour. * Phase 1: Light dose escalation. Three subjects will be treated per dose level (20 - 40 J/cm2). If no dose-limiting toxicities occur, dose will be escalated (20 - 40 J/cm2) until the Recommended Phase 2 Dose (RPD2) is established. * Phase 2: Cohort expansion with the RPD2.
DRUG
Verteporfin Injection
Verteporfin for Injection (VFI), photosensitizing drug, will be administered intravenously at a dose of 15 mg/m2 body surface area.
Primary outcome measures
Safety of treatment
Time frame: Within 4 weeks of treatment in each cohort.
Number of participants with treatment related adverse events as assessed by CTCAE v5.0 related to therapy per protocol. Dose limiting toxicities are defined as grade 3 non-hematologic or grade 4 hematologic toxicities that are possibly, probably or definitely related to PDT.
Safety - Damage to the periprostatic tissue mediated by PDT
Time frame: 5-9 days following PDT
Potential damage to the periprostatic tissue will be evaluated by contrast-enhanced and not-contrast enhanced MRI.
Treatment efficacy
Time frame: 6 and 18 months post PDT
Percentage of subjects with negative in-field biopsies (histopathologically tumor-free)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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. a. This prostate biopsy should be targeted and systematic (transperineal or transrectal are both acceptable) and include both systematic sampling with a minimum of 8 cores (4 right, 4 left) as well as MRI fusion targeted cores. The minimum number of targeted cores is two (2) but more may be included at the discretion of the surgeon.
- 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. \- Bone scan is optional if PSA \< 10 ng/mL.
- Treatment target volume \<50 cm3 defined by TRUS or MRI.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival ≥ 36 months.
- Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
- Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
- Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
- Signed Informed Consent.
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.
- Prior or current bleeding diathesis.
- Tumors known to be eroding into a major blood vessel in or adjacent to the illumination site.
- Use of Alpha-reductase inhibitors (ARIs) within 90 days of enrolment.
- Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).
- Mental incapacity or psychiatric illness that would interfere with the subject's ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator.
- Contraindication for photosensitizer including:
- Porphyria or other diseases exacerbated by light.
- Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
- Known allergies to porphyrins.
- On-going therapy with a photosensitizing agent.
- Enrolment in another therapeutic clinical study within 3 month prior to enrolment and throughout the study.
- Contraindication for MRI/Gadolinium contrast such as: implants, hip prosthesis, severe renal impairment (glomerular filtration rate \[GFR\] \<30 mL/min/1.73m2), or previous contrast reactions.
- Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations