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Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System

NCT03067051 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-05-01

No results posted yet for this study

Summary

The rationale for the study is to obtain safety and efficacy data as well as to establish dose parameters for the SpectraCure P18 System with IDOSE®, with verteporfin for injection (VFI) as photosensitizer for the treatment of recurrent prostate cancer.

Conditions

  • Recurrent Prostate Cancer

Interventions

DRUG

Verteporfin

In the last decade a clinical interest of developing new methods for minimally invasive treatments of organ-confined prostatic malignancies has been pursued. In this study the drug verteporfin for injection (VFI) is to be used with the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software).

DEVICE

SpectraCure P18 System

Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system

Sponsors & Collaborators

  • SpectraCure AB

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-21
Primary Completion
2027-07-31
Completion
2027-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Canada
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03067051 on ClinicalTrials.gov