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

About This Trial

This study is testing a new treatment that uses a light-activated medication combined with a specialized laser system to target and destroy cancer cells.
It is designed for men whose prostate cancer has returned locally after previous radiation therapy and has not spread to other parts of the body.
To join, patients must be in generally good health, have properly working kidneys and liver, and not be eligible for surgery.
Before considering this trial, patients should know that the procedure involves light-based therapy and MRI scans, making it unsuitable for individuals with severe light sensitivities, certain allergies, or specific medical implants.

More Information

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.

Who Can Enroll

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is testing a new treatment that uses a light-activated medication combined with a specialized laser system to target and destroy cancer cells.

Study Details

Start Date: March 21, 2017
Lead Sponsor: SpectraCure AB

Full 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.