Prostate CancerPhase 1/2NCT06807359
Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System
A Phase 1/2 study testing Photodynamic Therapy (PDT) and Verteporfin Injection in people with Prostate Cancer, run by SpectraCure AB at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Photodynamic Therapy (PDT) and Verteporfin Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 6 Jan 2025to Jan 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Germany2 sites, 2 recruiting
- Recruiting
Klinik für Urologie, Universitätsklinikum Köln
Cologne, 50937
Axel Heidenreich, Prof. Dr. med.
- Recruiting
Klinik und Poliklinik für Urologie, Universitätsmedizin Rostock
Rostock
Study Coordinator, 0381 494 147821, Ronja.Boysen@med.uni-rostock.de
Angelika Borkowetz, Prof. Dr. med.
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Jonathan Fainberg, MD, MPH
About this study
Official title: Open-label Clinical Phase 1/2 Study to Assess the Safety and Efficacy of the SpectraCure P18 System and Verteporfin for Injection for the Treatment of Primary Localized Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- Photodynamic Therapy (PDT), Verteporfin Injection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic Therapy (PDT)Device
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.
Verteporfin InjectionDrug
Also called Visudyne
Verteporfin for Injection (VFI), photosensitizing drug, will be administered intravenously at a dose of 15 mg/m2 body surface area.
| Study group | Role | What they receive |
|---|---|---|
| PDT with VFI | Experimental | Interstitial Photodynamic Therapy (PDT) and Verteporfin for Injection (VFI) Receives: Device: Photodynamic Therapy (PDT); Drug: Verteporfin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of treatment
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.
Measured: Within 4 weeks of treatment in each cohort.
Safety - Damage to the periprostatic tissue mediated by PDT
Potential damage to the periprostatic tissue will be evaluated by contrast-enhanced and not-contrast enhanced MRI.
Measured: 5-9 days following PDT
Treatment efficacy
Percentage of subjects with negative in-field biopsies (histopathologically tumor-free)
Measured: 6 and 18 months post PDT
Secondary outcomes (5)
Adequacy of effectiveness
Extent of quantifiable treatment effect in the prostate evaluated by MRI to determine the extent of necrosis in the prostate
Measured: Within 1 week following PDT
Treatment efficacy
Rate of negative in-field biopsy as defined by the Delphi consensus criterion (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant).
Measured: 6 and 18 months post PDT
Device performance
Light dose coverage >90% of the target volume; evaluated by dose-volume histograms in >80% of subjects
Measured: Day of PDT
Percentage of subjects with biochemical failure
Failure defined as a rise in PSA level of 2.0 ng/mL or more, over and above the nadir
Measured: 6 and 10 weeks, 6, 18, 24 and 36 months post PDT
Percentage of subjects with extra prostatic or distant disease
Remaining localized tumour will be evaluated by MRI
Measured: 6 and 18 months post PDT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start6 Jan 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Prospective, open-label, non-randomized multicenter study without control group. Phase 1 - Dose-escalation Phase 2 - Cohort expansion
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SpectraCure AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Fainberg, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center, New York, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807359
- Sponsor's protocol ID
- SPC11-02-110
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2025
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes