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

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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

Condition: Recurrent Prostate Cancer

Intervention:

  • Drug: Verteporfin
  • Device: SpectraCure P18 System

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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03067051

Sponsor: SpectraCure AB

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:

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:
  • Measure: Performance of SpectraCure P18 system
  • Time Frame: Dose-volume histograms will be evaluated at month 12
  • Safety Issue:
  • Measure: Adequacy of effectiveness
  • Time Frame: Within 1 week of treatment
  • Safety Issue:

Estimated Enrollment: 36

Study Start Date: March 21, 2017

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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.

Contact:

  • Johannes Swartling
  • +46 (0) 46 16 20 70

Locations:

  • Keith Cengel
  • Philadelphia Pennsylvania 19104-6205 United States
  • Princess Margaret Cancer Centre
  • Toronto Ontario ON M5G 2M9 Canada
  • Reader in Urology, University College London & Honorary Consultant Urological Surgeon, University College London Hospitals Trust
  • London W1W 7TS United Kingdom

View trial on ClinicalTrials.gov

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