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

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ClinicalTrials.gov Identifier: NCT03067051
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
SpectraCure AB

Tracking Information
First Submitted Date  ICMJE February 13, 2017
First Posted Date  ICMJE March 1, 2017
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE March 21, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2017)
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 ]
Dose limiting toxicities are defined as grade 3 non-hematologic or grade 4 hematologic toxicities that are possibly, probably or definitely related to PDT.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03067051 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2017)
  • Damage to the periprostatic tissues including the rectal wall mediated by PDT [ Time Frame: 5-9 days following PDT ]
    Potential damage to the periprostatic tissue will be evaluated by contrast-enhanced and not-contrast enhanced MRI .
  • Performance of SpectraCure P18 system [ Time Frame: 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
  • Adequacy of effectiveness [ Time Frame: Within 1 week of treatment ]
    Effectivity will be evaluated by MRI to determine the extent of necrosis in the prostate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Assess the Safety and Adequacy of Effectiveness of the SpectraCure P18 System
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Prostate Cancer
Intervention  ICMJE
  • 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 Name: Visudyne
  • Device: SpectraCure P18 System
    Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system
Study Arms  ICMJE 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 .

Interventions:
  • Drug: Verteporfin
  • Device: SpectraCure P18 System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 23, 2017)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Males with recurrent prostate cancer
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Johannes Swartling +46 (0) 46 16 20 70 jsw@spectracure.com
Listed Location Countries  ICMJE Canada,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03067051
Other Study ID Numbers  ICMJE SPC11-01-110
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SpectraCure AB
Study Sponsor  ICMJE SpectraCure AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SpectraCure AB
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP