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 : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Prostate Cancer||Drug: Verteporfin Device: SpectraCure P18 System||Phase 1|
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:
- 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 :||Interventional (Clinical Trial)|
|Estimated 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.|
|Masking:||None (Open Label)|
|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 :||March 21, 2017|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||August 31, 2019|
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 .
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: VisudyneDevice: SpectraCure P18 System
Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067051
|Contact: Johannes Swartling||+46 (0) 46 16 20 email@example.com|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, ON M5G 2M9|
|Contact: Neil Fleshner, MD|