A Phase I Study of Photodynamic Therapy in People with Recurrent Prostate Cancer

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Full Title

Open-Label Clinical Study to Assess the Safety and Adequacy of Effectiveness of the SpectraCure P18 System (Interstitial Multiple Diode Lasers and IDOSE Software) and Verteporfin for Injection (VFI) for the Treatment of Recurrent Prostate Cancer

Purpose

The purpose of this study is to see if delivering laser light directly to the prostate to activate a light-sensitive drug is a safe and effective treatment for prostate cancer that has come back after radiation therapy. The goal of this treatment is to eliminate any remaining prostate cancer cells. This approach is a form of photodynamic therapy (PDT).

The laser light will be delivered by a new PDT system called the SpectraCure P18; the light-sensitive drug used in this study is verteporfin, which is given intravenously (by vein) during the procedure. Doctors want to find the lowest effective dose of verteporfin to use and calculate the precise positioning of the fibers that deliver laser light to the prostate.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have prostate cancer that has come back after prior external beam radiation therapy to the prostate, but has not spread beyond the prostate.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. James Eastham at 646-422-4322.

Protocol

20-114

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Jonathan Coleman