Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer.
Condition: Localized Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: TOOKAD Soluble 4 mg/kg
Intervention description: Vascular targeted photodynamic therapy using TOOKAD Soluble
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial
Masking: None (Open Label)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial. Men with
      localized prostate cancer will receive TOOKAD® Soluble VTP under general anesthesia.

      To evaluate the absence of biopsy detectable Gleason grade 4 or 5 prostate cancer tumors
      anywhere in the prostate gland on 12-month, post-treatment biopsy following TOOKAD®
      Soluble-VTP in men with prostate cancer Gleason score 7(3+4).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men over 18 years of age.

          2. Patients who have had a multiparametric MRI of the prostate performed and have
             undergone transrectal systematic biopsy plus biopsy of any volumes considered
             suspicious per the MRI (PIRADS version 2 score of 4 or 5) within 6 months before
             signing consent.

          3. Histologic diagnosis of prostate cancer identifying Gleason score of 3+4 on one half
             of the prostate gland in no more than 2 sextants of the prostate gland and not present
             in more than 50% of any one core taken systematically. The involvement criterion does
             not apply to cores taken from MRI suspicious volumes.

          4. Patients with concomitant Gleason score 3+3 prostate cancer in less than 50% of any
             core at any site will be considered eligible.

          5. Prostate cancer stage up to cT2a - N0/Nx - M0/Mx.

          6. Prostate volume ≥25 mL and ≤70 mL.

          7. Serum PSA ≤10 ng/mL.

          8. Men who are sexually active with women of childbearing potential must use
             contraceptive method with a failure rate of less than 1% per year. Contraception
             should be continued for a period of 90 days after the VTP procedure. The individual
             methods of contraception may be determined in consultation

          9. Signed Informed Consent Form.

        Exclusion Criteria:

          1. Unwillingness to accept the treatment;

          2. Any prior or current treatment for prostate cancer, including surgery, radiation
             therapy (external or brachytherapy) or chemotherapy;

          3. Any surgical intervention for benign prostatic hypertrophy;

          4. Any condition or history of illness or surgery that might pose an additional risk to
             men undergoing the VTP procedure;

          5. Life expectancy less than 10 years;

          6. Participation in another clinical study involving an investigational product within 1
             month before study entry;

          7. Inability to understand the informed consent document, to give consent voluntarily or
             to complete the study tasks, especially inability to understand and fulfill the
             health-related QOL questionnaire;

          8. Subjects in custody and or residing in a nursing home or rehabilitation facility;

          9. Biopsy proven locally advanced or metastatic prostate cancer.

         10. Any condition or history of illness or surgery that in the opinion of the investigator
             might affect the conduct and results of the study or pose additional risks to the
             subject (e.g., cardiac or respiratory disease precluding general anesthesia;
             anticoagulant treatment which cannot be temporarily withdrawn for the procedure).

         11. Medical conditions that preclude the use of general anesthesia;

         12. Any condition or history of active rectal inflammatory bowel disease or other factors
             which might increase the risk of fistula formation;

         13. Hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen
             production within the previous 6 months;

         14. History of urethral stricture disease;

         15. History of acute urinary retention within 6 months of study entry;

         16. Condition requiring medication with potential photosensitizing effects (tetracyclines,
             quinolones, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide
             diuretics, griseofulvin, and amiodarone) if these treatments could not be stopped at
             least 10 days before and for 3 days after the VTP procedure or replaced by treatments
             without photosensitizing properties;

         17. Anticoagulant drugs (e.g., warfarin) that could not be withdrawn during the 10 days
             prior to the VTP procedure or antiplatelet drugs (e.g. aspirin) that could not be
             withdrawn during the 10 days prior to the VTP procedure and 3 days after VTP;

         18. Renal and hepatic disorders with values of >1.5 times the upper limit of normal (ULN)
             or blood disorders (upon clinician judgment);

         19. A history of sun hypersensitivity or photosensitive dermatitis.