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

Sponsor
SpectraCure AB (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03067051
Collaborator
(none)
36
Enrollment
3
Locations
1
Arm
45.4
Anticipated Duration (Months)
12
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Intervention Model:
Sequential Assignment
Intervention Model Description:
As result of the accelerated titration design with light dose and verteporfin for injection (VFI), the final number of subjects depends on the outcome of the titration. If all dose levels enroll and complete at the minimum number of subjects, the number of subjects is 12 (1 each at dose levels 1-3, 3 each at dose levels 4-6). If all dose levels enroll and complete at the maximum number of subjects, the number of subjects is 36 (6 subjects at each dose level 1-6). The range is thus 12-36 subjects.As result of the accelerated titration design with light dose and verteporfin for injection (VFI), the final number of subjects depends on the outcome of the titration. If all dose levels enroll and complete at the minimum number of subjects, the number of subjects is 12 (1 each at dose levels 1-3, 3 each at dose levels 4-6). If all dose levels enroll and complete at the maximum number of subjects, the number of subjects is 36 (6 subjects at each dose level 1-6). The range is thus 12-36 subjects.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 21, 2017
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
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 .

Drug: Verteporfin
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).
Other Names:
  • Visudyne

    • Device: SpectraCure P18 System
    Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system

    Outcome Measures

    Primary Outcome Measures

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

      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

    1. Damage to the periprostatic tissues including the rectal wall mediated by PDT [5-9 days following PDT]

      Potential damage to the periprostatic tissue will be evaluated by contrast-enhanced and not-contrast enhanced MRI .

    2. Performance of SpectraCure P18 system [Dose-volume histograms will be evaluated at month 12]

      Performance of the SpectraCure P18 system will be evaluated by light dose-volume histograms for the light dose coverage

    3. Adequacy of effectiveness [Within 1 week of treatment]

      Effectivity will be evaluated by MRI to determine the extent of necrosis in the prostate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • SpectraCure AB

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SpectraCure AB
    ClinicalTrials.gov Identifier:
    NCT03067051
    Other Study ID Numbers:
    • SPC11-01-110
    First Posted:
    Mar 1, 2017
    Last Update Posted:
    May 13, 2019
    Last Verified:
    May 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Verteporfin

    Study Results

    No Results Posted as of May 13, 2019