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NCT06807359 · ClinicalTrials.gov registry record · Phase 1
Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System
A Phase 1 study of Prostate Cancer, sponsored by SpectraCure AB.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 2
- Study locations
NCT06807359: Recruiting Phase 1 study of Prostate Cancer, sponsored by SpectraCure AB.
NCT06807359 is a Phase 1 study of Prostate Cancer that is actively recruiting participants, run by SpectraCure AB. The registered enrollment target is 43 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06807359, a Phase 1 study of Prostate Cancer, is actively recruiting participants, sponsored by SpectraCure AB.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Photodynamic Therapy (PDT)
- DRUG Verteporfin Injection
Study Locations (2)
New York
- Memorial Sloan Kettering Cancer Center - New York
Other
- Klinik für Urologie Universitätsklinikum Köln - Cologne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2025-01-06 |
| Est. Completion | 2029-01 |
| Phase | Phase 1 |
What NCT06807359 shows while recruiting
NCT06807359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Photodynamic Therapy (PDT) is the first listed.
NCT06807359 reports a single indexed study location in New York, Other.
Frequently Asked Questions
What is clinical trial NCT06807359 about?
NCT06807359 is a clinical study titled "Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System". 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 ...
What is the current status of trial NCT06807359?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2025-01-06. Estimated completion is 2029-01.
What conditions does trial NCT06807359 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT06807359?
The interventions under investigation include: Photodynamic Therapy (PDT) (DEVICE), Verteporfin Injection (DRUG).
Who is sponsoring clinical trial NCT06807359?
This trial is sponsored by SpectraCure AB, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06807359 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06807359's enrollment target sits among peer trials
43 516th of 735 higher than 217 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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