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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 7
- 主要终点
- Number of participants with treatment related adverse events as assesses by CTCAE v4.0 related to protocol therapy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Known allergies to porphyrins
- •Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
- •On-going therapy with a photosensitizing agent
- •Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
- •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.
- •Phase 2 Inclusion Criteria:
- •Subjects > 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
- •Treatment target volume less than 50 cm
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Expected survival ≥ 12 months.
- •Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm
- •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.
- •Phase 2 Exclusion Criteria:
- •Subjects with locally advanced (AJCC 7th edition T3/T4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET.
- •Subjects who have been treated with seed implantation brachytherapy.
- •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.
- •Known allergies to porphyrins.
- •Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
- •On-going therapy with a photosensitizing agent.
- •Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
- •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.
- •Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate [GFR] <30 mL/min/1.73m2, or previous contrast reactions.
- •On-going or planned hormone therapy.
研究组 & 干预措施
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 .
干预措施: SpectraCure P18 System (Device)
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 .
干预措施: Verteporfin (Drug)
结局指标
主要结局
Number of participants with treatment related adverse events as assesses by CTCAE v4.0 related to protocol therapy.
时间窗: 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.
时间窗: 6 months following PDT.
Histopathologically tumor-free.
次要结局
- 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.)