Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System

April 30, 2026 updated by: SpectraCure AB

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Cologne, Germany, 50937
        • Recruiting
        • Klinik für Urologie, Universitätsklinikum Köln
        • Principal Investigator:
          • Axel Heidenreich, Prof. Dr. med.
      • Rostock, Germany
        • Recruiting
        • Klinik und Poliklinik für Urologie, Universitätsmedizin Rostock
        • Contact:
        • Principal Investigator:
          • Angelika Borkowetz, Prof. Dr. med.
  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Jonathan Fainberg, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects ≥ 18 years.

  2. 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.

  3. Gleason Score 7 (3+4 or 4+3).
  4. PSA ≤ 15 ng/mL.
  5. Lesion volume on mpMRI < 1.5 cm3.

  6. 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.

  7. Treatment target volume <50 cm3 defined by TRUS or MRI.
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  9. Expected survival ≥ 36 months.
  10. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
  11. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
  12. 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.
  13. Signed Informed Consent.

Exclusion Criteria:

  1. Evidence of locally advanced, regional pelvic lymph node metastasis, or metastatic disease.
  2. Any suspicious for, probable, or definite extracapsular extension on pretreatment MRI
  3. Contralateral PIRADS 4/5 lesion (even if negative targeted biopsy)
  4. 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.
  5. Prior radical surgery for carcinoma of the prostate, prior pelvic radiation, prior TURP, prior cryosurgery of the prostate.
  6. Prior treatment with any form of brachytherapy.
  7. Previous androgen deprivation therapy (ADT) or chemotherapy for prostate cancer.
  8. Prior or current bleeding diathesis.
  9. Tumors known to be eroding into a major blood vessel in or adjacent to the illumination site.
  10. Use of Alpha-reductase inhibitors (ARIs) within 90 days of enrolment.
  11. 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).
  12. 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.

  13. Contraindication for photosensitizer including:

    1. Porphyria or other diseases exacerbated by light.
    2. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
    3. Known allergies to porphyrins.
  14. On-going therapy with a photosensitizing agent.
  15. Enrolment in another therapeutic clinical study within 3 month prior to enrolment and throughout the study.
  16. 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.
  17. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PDT with VFI
Interstitial Photodynamic Therapy (PDT) and Verteporfin for Injection (VFI)
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.
Other Names:
  • Visudyne

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within 4 weeks of treatment in each cohort.
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.
5-9 days following PDT
Treatment efficacy
Time Frame: 6 and 18 months post PDT
Percentage of subjects with negative in-field biopsies (histopathologically tumor-free)
6 and 18 months post PDT

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adequacy of effectiveness
Time Frame: Within 1 week following PDT
Extent of quantifiable treatment effect in the prostate evaluated by MRI to determine the extent of necrosis in the prostate
Within 1 week following PDT
Treatment efficacy
Time Frame: 6 and 18 months post PDT
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).
6 and 18 months post PDT
Device performance
Time Frame: Day of PDT
Light dose coverage >90% of the target volume; evaluated by dose-volume histograms in >80% of subjects
Day of PDT
Percentage of subjects with biochemical failure
Time Frame: 6 and 10 weeks, 6, 18, 24 and 36 months post PDT
Failure defined as a rise in PSA level of 2.0 ng/mL or more, over and above the nadir
6 and 10 weeks, 6, 18, 24 and 36 months post PDT
Percentage of subjects with extra prostatic or distant disease
Time Frame: 6 and 18 months post PDT
Remaining localized tumour will be evaluated by MRI
6 and 18 months post PDT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SpectraCure AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan Fainberg, MD, MPH, Memorial Sloan Kettering Cancer Center, New York, United States

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPC11-02-110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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