Patients with prostate carinoma who will undergo radical prostatectomy. MedDRA version: 9.1 Level: LLT Classification code 10036921 Term: Prostate carcinoma
Conditions
Interventions
Product Name: 5-ALA
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: 5-Aminolävulinsäurehydrochlorid
CAS Number: 5451-09-2
Concentration unit: mg/kg milligram(s)/kilogram
Concentrati
Sponsors
Klinikum der Universität München
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients with histologically proven prostate caricinoma. Indication for radical prostatectomy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Renal insufficiency. Porphyria or allergy to porphyrines. Hepatic insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Intraoperative investigation of surgical margins for residual tumor.;Secondary Objective: Practicability of PDD in the open vs. laparoscopic/extraperitoneal endoscopic operation technique. PPIX-accumulation in tumors of different differentiation grade.;Primary end point(s): Absence or adsence of fluorescence in positive or negative surgical margins, as well as concordance of fluorescing areas with histological findings. | — |
Countries
Germany
Outcome results
None listed