Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System (NCT03067051) | Clinical Trial Compass
RecruitingPhase 1/2
Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System
United States, Canada, Sweden66 participantsStarted 2017-03-21
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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
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)
What they're measuring
1
Number of participants with treatment related adverse events as assesses by CTCAE v4.0 related to protocol therapy.
Timeframe: Within 4 weeks of treatment in each cohort.
✕. 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