ClinicaliQ Trial Snapshot
- Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System — Recruiting • Phase I • Oncology • NCT03067051.
- What is being tested: The SpectraCure P18 System combined with verteporfin (a photosensitizer) is being evaluated for safety, efficacy, and optimal dosing parameters in treating recurrent prostate cancer using interstitial photodynamic therapy (PDT).
- Patient eligibility overview: The study focuses on men with recurrent prostate cancer who are candidates for this novel treatment approach, though specific inclusion/exclusion criteria would be detailed in the full protocol.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- 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
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.