Clinical Trials /

Clinical Study to Assess the Safety and Adequacy of Effectiveness of the SpectraCure P18 System

NCT03067051

Description:

The rationale for the study is to obtain safety 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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Clinical Study to Assess the Safety and Adequacy of Effectiveness of the SpectraCure P18 System
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: SPC11-01-110
  • NCT ID: NCT03067051

Conditions

  • Recurrent Prostate Cancer

Interventions

DrugSynonymsArms
VerteporfinVisudynePDT and verteporfin dose finding

Purpose

The rationale for the study is to obtain safety 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.

Detailed Description

      In 2011, more than 200,000 men in North America alone were diagnosed with cancer of the
      prostate, which makes it one of the most common cancer types. It affects the lives of the
      subjects in many ways.

      After treatment the subjects PSA levels are being closely monitored to detect potential
      recurrence. A high number of subjects will get recurrent prostate cancer. The treatment
      options for recurrent cancer are more limited than for primary tumors as secondary treatment
      partly depends on which treatment the subject has previously undergone.

      Treatment of recurrent prostate cancer may, depending on the standard treatment of the
      primary disease, include the following:

      Radiation therapy.

        -  Prostatectomy for subjects initially treated with radiation therapy.

        -  Hormone therapy.

        -  Pain medication, external radiation therapy, internal radiation therapy with
           radioisotopes such as strontium-89, or other treatments as palliative therapy to lessen
           bone pain.

      The objectives of this study is to demonstrate that the use of the SpectraCure P18 System
      (Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI)
      is a safe treatment for recurrent prostate cancer.
    

Trial Arms

NameTypeDescriptionInterventions
PDT and verteporfin dose findingExperimentalVerteporfin 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 .
  • Verteporfin

Eligibility Criteria

        Inclusion Criteria:

          1. Males > 18 years who have gone through external or internal, high dose rate (brachy)
             radiation therapy for localized prostate cancer with histopathologically verified
             local recurrence.

          2. Prostate volume less than 50 cm3 defined by transrectal ultrasound

          3. Subject not eligible for surgery or curative radiotherapy

          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          5. Expected survival ≥ 8 months

          6. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet
             count ≥ 100,000/mm3

          7. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl

          8. Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum
             glutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and
             alanine transaminase (ALT) ≤ 3 times the upper limit of normal

          9. Signed Informed Consent

        Exclusion Criteria:

          1. Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease

          2. Patients who have been treated with seed implantation brachytherapy

          3. Gleason score ≥ 8 at initial diagnosis

          4. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access
             device insertion)

          5. Concomitant infection

          6. Subjects with other severe concurrent disease that in the judgement of the
             investigator would make the subject inappropriate for entry into this study

          7. Mental incapacity or psychiatric illness that would interfere with the subject's
             ability to understand and give informed consent or to complete follow-up visits
             according to the judgement of the investigator

          8. Contraindication for photosensitizer

          9. Porphyria or other diseases exacerbated by light

         10. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients

         11. Known allergies to porphyrins

         12. Tumours known to be eroding into a major blood vessel in or adjacent to the
             illumination site

         13. On-going therapy with a photosensitizing agent

         14. Enrolment in another therapeutic clinical study within 3 months prior to randomization
             and throughout the study.

         15. Subjects with a history of CTCAE v4 grade 3 or greater or persistent (>1 separate
             episode or symptoms lasting more than 3 months after initiation of medical
             intervention) grade 2 proctitis attributed to radiation.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

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 cohorte
Safety Issue:
Description:Dose limiting toxicities are defined as grade 3 non-hematologic or grade 4 hematologic toxicities that are possibly, probably or definitely related to PDT.

Secondary Outcome Measures

Measure:Damage to the periprostatic tissues including the rectal wall mediated by PDT
Time Frame:5-9 days following PDT
Safety Issue:
Description:Potential damage to the periprostatic tissue will be evaluated by contrast-enhanced and not-contrast enhanced MRI .
Measure:Performance of SpectraCure P18 system
Time Frame:Dose-volume histograms will be evaluated at month 12
Safety Issue:
Description:Performance of the SpectraCure P18 system will be evaluated by light dose-volume histograms for the light dose coverage
Measure:Adequacy of effectiveness
Time Frame:Within 1 week of treatment
Safety Issue:
Description:Effectivity will be evaluated by MRI to determine the extent of necrosis in the prostate

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:SpectraCure AB

Last Updated

May 10, 2019