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

Launched by SPECTRACURE AB · Feb 23, 2017

Keywords

ClinConnect Summary

The clinical trial titled "Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System" is looking at a new treatment option for men with recurrent prostate cancer. The study aims to gather information on how safe and effective the SpectraCure P18 System is when combined with a special drug called verteporfin. This trial is currently recruiting male participants aged 18 and older who have had prior radiation treatment for localized prostate cancer and have a confirmed local recurrence. To be eligible, participants must have a prostate volume of less than 50 cubic centimeters and cannot be suitable for further surgery or traditional radiation therapy.

If you decide to participate in this trial, you can expect to undergo treatment with the SpectraCure P18 System and receive regular check-ups to monitor your health. Participants must also sign a consent form agreeing to take part in the study. It's important to note that certain health conditions or prior treatments might make someone ineligible for this trial, so discussing your specific situation with your healthcare provider is crucial. This study represents a potential new avenue for managing recurrent prostate cancer, and your involvement could contribute valuable information to the medical community.

Gender

MALE

Eligibility criteria

• Phase 1 Inclusion 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
• Phase 1 Exclusion Criteria:
• • 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.
• Phase 2 Inclusion Criteria:
• • 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.
• • 2. Treatment target volume less than 50 cm3.
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • 4. Expected survival ≥ 12 months.
• • 5. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
• • 6. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
• • 7. 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.
• • 8. Signed Informed Consent.
• Phase 2 Exclusion Criteria:
• • 1. Subjects with locally advanced (AJCC 7th edition T3/T4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET.
• • 2. Subjects who have been treated with seed implantation brachytherapy.
• • 3. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
• • 4. Concomitant infection.
• • 5. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
• • 6. 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.
• • 7. Contraindication for photosensitizer.
• • 8. Porphyria or other diseases exacerbated by light.
• • 9. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
• • 10. Known allergies to porphyrins.
• • 11. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
• • 12. On-going therapy with a photosensitizing agent.
• • 13. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
• • 14. 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.
• • 15. Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate \[GFR\] \<30 mL/min/1.73m2, or previous contrast reactions.
• • 16. On-going or planned hormone therapy.