Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System

Official title

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

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.

Interventions

• 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).
• Device SpectraCure P18 System
  Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system

Primary outcome measures

• 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.]
• Percentage of subjects with negative biopsies. [Time frame: 6 months following PDT.]

Secondary outcome measures (6)

• Damage to the periprostatic tissues including the rectal wall mediated by PDT [Time frame: 5-9 days following PDT]
• Performance of SpectraCure P18 system [Time frame: Dose-volume histograms will be evaluated at month 12]
• Adequacy of effectiveness [Time frame: Within 1 week of treatment]
• Percentage of subjects with remaining localized tumour. [Time frame: 12 months following PDT.]
• Percentage of subjects with biochemical failure. [Time frame: 12 months following PDT.]
• Percentage of subjects with extra prostatic or distant disease. [Time frame: 12 months following PDT.]

Eligibility 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

Phase 1 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
• 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 cm3.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Expected survival ≥ 12 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Memorial Sloan Kettering Cancer Center — New York

Canada · 1 center

• Princess Margaret Cancer Centre — Toronto

Sweden · 1 center

• Skåne University Hospital — Malmö

United Kingdom · 1 center

• Reader in Urology, University College London & Honorary Consultant Urological Surgeon, Uni — London

Identifiers

NCT: NCT03067051 · SPC11-01-110

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗