Study on Photodynamic Therapy for Localized Prostate Cancer Using the SpectraCure P18 System

Sponsor: SpectraCure AB

Sponsor score: 0

ClinicalTrials ID:NCT06807359

Provider View

This clinical trial is testing a new treatment for localized prostate cancer using the SpectraCure P18 System with a special light-activated drug. The study aims to determine the safety, effective dosage, and effectiveness of this treatment over a period of 36 months.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment for localized prostate cancer using the SpectraCure P18 System. This treatment involves using a light-sensitive drug called verteporfin, which is activated by light to target cancer cells. The study is divided into two parts: Phase I will focus on finding a safe and effective light dose, while Phase II will assess how well the treatment works and confirm its safety. Participants will be monitored for 18 months to determine the primary outcome, with an additional 18 months of follow-up for long-term results. The treatment, called Interstitial Photodynamic Therapy (PDT), will be performed under general anesthesia. Optical fibers will be inserted into the prostate to deliver the light, guided by ultrasound. Participants will receive the drug intravenously about 60-90 minutes before the light treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of prostate cancer that is confined to the prostate and diagnosed within the last 9 months.
  • Have a Gleason Score of 7 (3+4 or 4+3).
  • PSA level must be 15 ng/mL or lower.
  • Lesion size on MRI must be less than 1.5 cm3.
  • Recent imaging tests must confirm the cancer is localized.
  • Treatment target area must be less than 50 cm3.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Expected to live at least 36 months.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Must sign an informed consent form.

Exclusion Criteria

  • Cancer has spread beyond the prostate or to lymph nodes.
  • MRI shows signs of cancer spreading outside the prostate.
  • High volume of low-grade cancer in the opposite side of the prostate.
  • Previous major prostate surgeries or treatments like radiation or cryosurgery.
  • Previous hormone therapy or chemotherapy for prostate cancer.
  • Bleeding disorders or tumors near major blood vessels.
  • Use of certain medications like Alpha-reductase inhibitors recently.
  • Serious medical conditions or infections that could interfere with the study.
  • Mental health issues that affect understanding or consent.
  • Allergies to the photosensitizer or related substances.
  • Currently using other light-sensitive medications.
  • Participation in another clinical study recently.
  • Conditions that prevent MRI use, like certain implants or severe kidney issues.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Cancer Center10065New YorkNew York

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