NCT03067051 Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System
| NCT ID | NCT03067051 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | SpectraCure AB |
| Condition | Recurrent Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2017-03-21 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 66 participants in total. It began in 2017-03-21 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03067051 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Recurrent Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03067051 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03067051 currently recruiting?
Yes, NCT03067051 is actively recruiting participants. Contact the research team at jsw@spectracure.com for enrollment information.
Where is the NCT03067051 trial being conducted?
This trial is being conducted at New York, United States, Toronto, Canada, Malmö, Sweden, London, United Kingdom.
Who is sponsoring the NCT03067051 clinical trial?
NCT03067051 is sponsored by SpectraCure AB. The trial plans to enroll 66 participants.
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