Prostate cancer Prostate cancer
Conditions
Interventions
Araglio 20 mg/kg, which is not approved for prostate cancer, is administered orally prior to surgery, and robot-assisted radical prostatectomy is performed.
5-ALA: 5-Aminolevulinic Acid Hydrochloride
Sponsors
Ito Hiroki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Men aged 20 to 79 years at the time of registration (2) Patients diagnosed with prostate cancer without metastasis (3) Patients who have given written consent to participate in this study
Exclusion criteria
Exclusion criteria: (1) Patients with a history of hypersensitivity to this drug or porphyrins (2) Patients with porphyria (3) Patients with severe cardiovascular disease (4) Patients for whom discontinuation of antihypertensive medication for hypertension is difficult from the day before to the day of investigational drug administration (5) Patients with hepatic dysfunction (6) Patients with renal dysfunction (7) Patients deemed inappropriate for inclusion in this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirm the consistency between the video evaluation results and the pathological results, and calculate the sensitivity (the percentage of positive cases that were illuminated). | — |
Secondary
| Measure | Time frame |
|---|---|
| Specificity (percentage of negative cases that did not glow) when comparing pathological results with the results of this agent, positive predictive value, and negative predictive value. Presence or absence of side effects from oral administration of Alagrio. | — |
Contacts
Public ContactHiroki Ito
Yokohama City University Hospital
Outcome results
None listed