None listed
Conditions
Interventions
TOOKAD® Soluble is a lyophilised product for IV injection, with 400mg powder presented in vials. Before administration, the product is extemporarily reconstituted with 40mL of a 5% solution of Glucose
Sponsors
Steba biotech S.A,
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects will be eligible for inclusion in the study if all of the following criteria are met: Histologically proven localized prostate carcinoma diagnosed using available prostate biopsy showing: Gleason 3+3 Gleason 3+4 is acceptable provided it is not present in more than 2 cores and no more than 50% cancer in any core. Clinical stage up to cT2a – N0/Nx – M0/Mx. Prostate volume ≥ 25 cc and ≤ 70 cc. Serum prostate-specific antigen (PSA) < 20 ng/mL. Male subjects aged 18 years or older. Signed Informed Consent Form by the patient.
Exclusion criteria
Exclusion criteria: Subjects will not be eligible for the study if meeting any of the following criteria: Unwillingness to accept the treatment. Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy. Any surgical intervention for benign prostatic hypertrophy. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure. Life expectancy less than 10 years. Participation in another clinical study involving an investigational product within 1 month before study entry. Subject unable to understand the patient’s informed consent document, to give consent voluntarily or to complete the study tasks, especially unable to understand and fulfill the health-related QoL questionnaire. Subject in custody and or in residence in a nursing home or rehabilitation facility.
Countries
Argentina, Brazil, Chile, Colombia, Mexico, Panama, Peru
Contacts
Public ContactLeopoldo Valdez
ACTIVA CRO PERU SOCIEDAD ANONIMA CERRADA
Outcome results
None listed