Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Symptoms and General Pathology

Prostatic Neoplasms

Erectile Dysfunction

Urinary Incontinence

Enuresis

Nocturnal Enuresis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lower Urinary Tract Symptoms

Urological Manifestations

Behavioral Symptoms

Elimination Disorders

Mental Disorders

Psychotic Disorders

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Quality of Life

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Anesthetics, General

TOOKAD is administered as part of focal VTP under general anaesthetic. TOOKAD® VTP consists of the combination of a single, 10-minute IV infusion of TOOKAD® at the dose of 3.66 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds.

TOOKAD® VTP consists of the combination of a single, 10-minute IV infusion of TOOKAD® at the dose of 3.66 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds.

TOOKAD VTP

Abdel-Rahmène AZZOUZI, Professor

Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial in men with unilateral prostate cancer meeting eligibility criteria for the drug (as per the European Economic Area (EEA) Marketing Authorisation) to assess the occurrence and dynamics of the time with toxicities (urinary incontinence Grade 2 and over and/or erectile dysfunction Grade 2 and over) in patients 12 months following TOOKAD® VTP.

This is a multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial. Men with unilateral prostate cancer meeting eligibility criteria for the drug (as per the EEA Marketing Authorisation) will receive TOOKAD® VTP under general anesthesia. The primary objective is to assess the occurrence and dynamics of the time with toxicities (urinary incontinence Grade 2 and over and/or erectile dysfunction Grade 2 and over) in patients 12 months following TOOKAD® VTP. Prior to the TOOKAD® VTP, patients will undergo routine ultrasound examination in the operating room for morphometric description of the prostate and to facilitate accurate treatment guidance for the treatment with TOOKAD® VTP. Treatment will then be applied to the prostate gland as a hemi-ablation procedure designed to destroy the lobe of the prostate gland that contains the cancer. Afterwards, patients will be followed for 12 months with clinical evaluation, data collection on erectile and urinary functions at 1, 2, 3 6 and 12 months, using the Expanded Prostate Cancer Index Composite (EPIC), International Index of Erectile Function (IIEF) and International Prostate Score Symptom (IPSS) questionnaires on Quality Of Life (QOL) and Prostate Specific Antigen (PSA) testing at 3, 6 and 12 months.

The clinical follow-up of patients will follow local standard of care processes, based on recommendations in the European Summary of Product Characteristics (SmPC).

This study is a phase IV pragmatic trial using optimal dose of TOOKAD® and optimal light-energy level conditions that were determined during development and approved by the European Commission.

Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial.

Study of Erectile Dysfunction, Urinary Incontinence and Related QoL After TOOKAD® VTP for Low Risk Prostate Cancer

Study of Erectile Dysfunction, Urinary Incontinence and Related Quality of Life After TOOKAD® Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Unilateral Low Risk Prostate Cancer

Time to onset, average duration and average time to resolution (either Erectile Dysfunction (ED) and/or Urinary Incontinence(UI)) during the 12 months following VTP of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument

Prevalence at different points in time (either ED and/or UI) during the 12 months following VTP of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument.

Area under the curve with the presence of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument

Time to onset, duration, time to resolution of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument

Prevalence at different points in time of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument

Area under the curve with the presence of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument

Time to onset, duration, time to resolution of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument,

Prevalence at different points in time of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument.

Area under the curve with the presence of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument.

Average variation on urinary symptoms (UI) using the EPIC and IPSS instruments, erectile functions (ED) using the EPIC and IIEF instruments, and bowel function using the EPIC instrument, prior to treatment beginning and then at 1, 2, 3, 6 and 12 months after completing treatment: absolute scores and changes as compared to baseline (absolute difference of means and proportion change)

Average changes from baseline in PSA density at month 12

Rate of adverse events (AE) of TOOKAD® VTP treatment : all AE, important AE identified in Risk Management Plan (RMP) and suspected AE listed in RMP.

Time to resolution of adverse events for each adverse event reported

Rate of additional treatment as decided by local practice, such as radical therapy (surgical removal of the prostate gland, radiation treatment to the prostate gland) or other intervention therapy to the ipsilateral and/or contralateral lobe, use of hormone or chemotherapies.

Rate of reported extension of prostate cancer based on locally decided investigations (such as clinical examination, biopsy, Magnetic resonance Imaging (MRI), other).

Spots Global Cancer Trial Database for tookad vtp

Every month we try and update this database with for tookad vtp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tookad vtp

Every month we try and update this database with for tookad vtp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tookad vtp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.