RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2017-03-21

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03067051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. Prostate volume less than 50 cm3 defined by transrectal ultrasound 3. Subject not eligible for surgery or curative radiotherapy 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Expected survival ≥ 8 months 6. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3 7. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl 8. 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 9. Signed Informed Consent	1. Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease 2. Patients who have been treated with seed implantation brachytherapy 3. Gleason score ≥ 8 at initial diagnosis 4. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion) 5. Concomitant infection 6. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study 7. 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 8. Contraindication for photosensitizer 9. Porphyria or other diseases exacerbated by light 10. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients 11. Known allergies to porphyrins 12. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site 13. On-going therapy with a photosensitizing agent 14. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study. 15. 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.

Inclusion Criteria

Exclusion Criteria

1. 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.
2. Prostate volume less than 50 cm3 defined by transrectal ultrasound
3. Subject not eligible for surgery or curative radiotherapy
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Expected survival ≥ 8 months
6. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3
7. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl
8. 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
9. Signed Informed Consent

1. Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease
2. Patients who have been treated with seed implantation brachytherapy
3. Gleason score ≥ 8 at initial diagnosis
4. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
5. Concomitant infection
6. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study
7. 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
8. Contraindication for photosensitizer
9. Porphyria or other diseases exacerbated by light
10. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
11. Known allergies to porphyrins
12. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
13. On-going therapy with a photosensitizing agent
14. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
15. 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.

Contacts and Locations

Study Contact

Johannes Swartling

CONTACT

+46 (0) 46 16 20 70

jsw@spectracure.com

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: SpectraCure AB

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-03-21

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2017-03-21

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Prostate Cancer