Open-label Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System (Interstitial Multiple Diode Lasers and IDOSE® Software) and Verteporfin for Injection (VFI) for the Treatment of Recurrent Prostate Cancer
Overview
- Phase
- Phase 1
- Intervention
- SpectraCure P18 System
- Conditions
- Recurrent Prostate Cancer
- Sponsor
- SpectraCure AB
- Enrollment
- 66
- Locations
- 7
- Primary Endpoint
- Number of participants with treatment related adverse events as assesses by CTCAE v4.0 related to protocol therapy.
- Status
- Recruiting
- Last Updated
- yesterday
Overview
Brief Summary
The rationale for the study is to obtain safety and efficacy 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Phase 1 Inclusion Criteria:
- •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.
- •Prostate volume less than 50 cm3 defined by transrectal ultrasound
- •Subject not eligible for surgery or curative radiotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Expected survival ≥ 8 months
- •Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3
- •Adequate renal function as defined by creatinine ≤ 1.5 mg /dl
- •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
- •Signed Informed Consent
Exclusion Criteria
- •Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease
- •Patients who have been treated with seed implantation brachytherapy
- •Gleason score ≥ 8 at initial diagnosis
- •Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
- •Concomitant infection
- •Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study
- •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
- •Contraindication for photosensitizer
- •Porphyria or other diseases exacerbated by light
- •Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
Arms & Interventions
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 .
Intervention: SpectraCure P18 System
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 .
Intervention: Verteporfin
Outcomes
Primary Outcomes
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 cohort.
Dose limiting toxicities are defined as grade 3 non-hematologic or grade 4 hematologic toxicities that are possibly, probably or definitely related to PDT.
Percentage of subjects with negative biopsies.
Time Frame: 6 months following PDT.
Histopathologically tumor-free.
Secondary Outcomes
- Damage to the periprostatic tissues including the rectal wall mediated by PDT(5-9 days following PDT)
- Performance of SpectraCure P18 system(Dose-volume histograms will be evaluated at month 12)
- Adequacy of effectiveness(Within 1 week of treatment)
- Percentage of subjects with remaining localized tumour.(12 months following PDT.)
- Percentage of subjects with biochemical failure.(12 months following PDT.)
- Percentage of subjects with extra prostatic or distant disease.(12 months following PDT.)