Study of the Efficacy and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
Study of the Efficacy and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Prostate Cancer
The study is designed as a multicenter, single-arm, open label, 12 months follow-up clinical
trial. Men with localized prostate cancer will be treated with TOOKAD® Soluble VTP under
general anesthesia.
Patients will be followed-up for 12 months with patient questionnaires on QoL, erectile and
urinary functions, clinical evaluation with study visits at 1, 3, 6 and 12 months , Prostate
Specific Antigen(PSA) testing at 3, 6 and 12 months. In addition, they will have biopsy at 6
months (± 2) and 12 months.
Inclusion Criteria:
- Histologically proven localized prostate carcinoma diagnosed using prostate biopsy
showing:
- Gleason 3+3 prostate
- Gleason 3+4 prostate adenocarcinoma 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.
- Male subjects aged 18 years or older.
- Signed Informed Consent Form by the patient.
Exclusion 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To confirm that a significant proportion of patients will be prostate cancer free on the biopsy.
Outcome Description:
Number of patients with a negative biopsy.
Outcome Time Frame:
Month 12
Safety Issue:
No
Principal Investigator
Jose Arturo Rodriguez Rivera, Dr
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital General Tlahuac
Authority:
Mexico: Federal Commission for Sanitary Risks Protection
Study ID:
CLIN1201 PCM304
NCT ID:
NCT01875393
Start Date:
May 2013
Completion Date:
December 2014
Related Keywords:
- Prostate Cancer
- Prostatic Disease
- Genital Neoplasm,male
- Urogenital neoplasm
- Genital disease,male
- Male urogenital disease
- Neoplasms
- Neoplasms by site
- Prostatic neoplasm
- Carcinoma
- Prostatic Neoplasms
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