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

Part of paid clinical trials in New York, New York.

Sponsor
SpectraCure AB
Study ID
NCT03067051
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Recurrent Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Verteporfin — DRUG
    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).
  • SpectraCure P18 System — DEVICE
    Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system

Study Details

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.

Key Dates

Start date
Mar 21, 2017
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PDT and verteporfin dose finding
    Verteporfin and Interstitial Photodynamic Therapy are the interventions in this dose titration study. The interventions will be light dose (as laser) using the SpectraCure P18 System and drug intervention with verteporfin as a photosensitizer. The study will be conducted as a dose titration study to determine the light and drug threshold dose using the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI). The light is delivered to the tumor via optical fibers and each dose arm will receive Interventional Photodynamic Therapy of Prostate Cancer combined with the drug verteporfin as a photosensitizer .

Primary Outcome Measure

Number of participants with treatment related adverse events as assesses by CTCAE v4.0 related to protocol therapy. [ Time Frame: Within 4 weeks of treatment in each cohort. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
James Eastham, MD

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Memorial Sloan Kettering Cancer Center· New York, NY

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