Open-label clinical phase 1/2 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
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Phase 1: Safety will be evaluated by toxicity related to protocol therapy, scored according to CTCAE v4.0. In addition, PDT-mediated severe damage to the periprostatic tissues, including the rectal wall, will be evaluated by contrast-enhanced and non-contrast MRI images obtained 5-9 days following PDT.
研究概览
简要总结
(i) 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 patients with recurrent prostate cancer, and (ii) demonstrate that the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) is able to calculate, deliver and control the required light dose for elimination of cancer cells in locally recurrent prostate cancer tumours, and (iii) demonstrate that the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) is able to calculate the precise positioning of the fibers for maximum effective light delivery, and (iv) determine the lowest safe and effective drug dose as well as the lowest safe and effective light dose as determined by MRI response and adverse events. (v) ascertain the dose level and assess clinical efficacy of the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI) for treatment of recurrent prostate cancer.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Overall trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Phase 1: 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.
- •Phase 2: 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.
- •Phase 2: Treatment target volume less than 50 cm
- •Phase 2: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Phase 2: Expected survival ≥ 12 months.
- •Phase 2: Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm
- •Phase 2: Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
- •Phase 2: Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamateoxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
- •Phase 2: Signed Informed Consent.
- •Phase 1: Treatment target volume less than 50 cm3 defined by transrectal ultrasound.
- •Phase 1: Subject not eligible for surgery or curative radiotherapy.
- •Phase 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Phase 1: Expected survival ≥ 8 months.
- •Phase 1: Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm
- •Phase 1: Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
- •Phase 1: Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamateoxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
- •Phase 1: Signed Informed Consent
排除标准
- •Phase 1: Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease.
- •Phase 1: Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
- •Phase 1: Concomitant infection
- •Phase 1: Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
- •Phase 1: 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.
- •Phase 1: Contraindication for photosensitizer
- •Phase 1: Porphyria or other diseases exacerbated by light.
- •Phase 1: Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate [GFR] <30 mL/min/1.73m2, or previous contrast reactions.
- •Phase 2: Subjects with locally advanced (AJCC 7th edition T3/T4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET.
- •Phase 2: Subjects who have been treated with seed implantation brachytherapy
- •Phase 2: Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
- •Phase 1: Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
- •Phase 2: Concomitant infection.
- •Phase 2: Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
- •Phase 2: 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.
- •Phase 2: Contraindication for photosensitizer.
- •Phase 2: Porphyria or other diseases exacerbated by light.
- •Phase 2: Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
- •Phase 2: Known allergies to porphyrins.
- •Phase 2: Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
- •Phase 2: On-going therapy with a photosensitizing agent.
- •Phase 2: Enrollment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
- •Phase 1: Known allergies to porphyrins.
- •Phase 1: Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
- •Phase 1: On-going therapy with a photosensitizing agent.
- •Phase 1: Enrollment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
- •Phase 1: Subjects with a history of CTCAE v4 grade 3 or greater or persistent (>1 separate episodes or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation.
- •Phase 1: Patients who have been treated with seed implantation brachytherapy.
- •Phase 1: Gleason score 10 at initial diagnosis.
结局指标
主要结局
Phase 1: Safety will be evaluated by toxicity related to protocol therapy, scored according to CTCAE v4.0. In addition, PDT-mediated severe damage to the periprostatic tissues, including the rectal wall, will be evaluated by contrast-enhanced and non-contrast MRI images obtained 5-9 days following PDT.
Phase 1: Safety will be evaluated by toxicity related to protocol therapy, scored according to CTCAE v4.0. In addition, PDT-mediated severe damage to the periprostatic tissues, including the rectal wall, will be evaluated by contrast-enhanced and non-contrast MRI images obtained 5-9 days following PDT.
Phase 1: Performance endpoint for the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) will be evaluated by light dose-volume histograms for the light dose coverage. Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects.
Phase 1: Performance endpoint for the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) will be evaluated by light dose-volume histograms for the light dose coverage. Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects.
Phase 2: Efficacy - Percentage of subjects with negative biopsies (histopathologically tumor-free) 6 months after PDT procedure. A proportion of subjects with negative biopsies of 0.75 at 6 months in phase 2 is expected and is considered clinically meaningful.
Phase 2: Efficacy - Percentage of subjects with negative biopsies (histopathologically tumor-free) 6 months after PDT procedure. A proportion of subjects with negative biopsies of 0.75 at 6 months in phase 2 is expected and is considered clinically meaningful.
次要结局
- Phase 1: Adequacy of effectiveness will be evaluated by MRI within one week to determine the extent of necrosis in the prostate (>70% of target volume in >50% of subjects).
- Phase 2: Efficacy - Percentage of subjects with remaining localized tumour evaluated by MRI 12 months following PDT. Percentage of subjects with biochemical failure defined as a rise in PSA level of 2.0 ng/mL or more, over and above the nadir obtained 6 weeks following PDT, confirmed by a second PSA value 4 weeks later. Percentage of subjects with extra prostatic or distant disease evaluated by PSMA PET 12 months following PDT in case of biochemical failure.
- Phase 2: Performance - The SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) will be evaluated by light dose-volume histograms for the light dose coverage. Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects.
- Phase 2: Safety - Adverse events will be collected throughout the study. Assessment of toxicity according to CTCAE v5.0 related to therapy per protocol. In addition, any PDT-mediated severe damage to the periprostatic tissues will be evaluated by MRI images obtained 5-9 days post-PDT. The threshold for success is anticipated to be no Grade 3 toxicity to the rectum or bladder assessed on MRI or any drug-related Serious Adverse Events.
研究者
Public Contact Point
Scientific
SpectraCure AB (publ)