Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Urogenital Diseases

Urogenital Neoplasms

Male Urogenital Diseases

Genital Diseases

Prostatic Diseases

Genital Diseases, Male

Genital Neoplasms, Male

TOOKAD® Soluble, lyophilized formulation, given at a dose of 4mg/Kg.

Active surveillance is one of the management strategy in men who have low-risk prostate cancer

TOOKAD® Soluble-VTP procedure will consist of an IntraVenous (IV) administration to patients using a 753nm laser light at a fixed power of 150mW/cm and a fixed energy at 200J/cm delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance

TOOKAD® Soluble

Mark Emberton, Professor

The aims of this study are:

* to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and
* to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).

This is a Phase 3, multicentre, open label, randomised controlled study in subjects diagnosed with low risk prostate cancer on TransRectal Ultrasound (TRUS) guided biopsy.

Subjects will be randomised to either Active Surveillance or TOOKAD® Soluble VTP. Subjects will remain in the study for approximately 24 months following randomisation. A total of 400 subjects will be entered into the study; 200 will receive Active Surveillance and 200 will receive TOOKAD® Soluble-VTP.

Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.

A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance

The data are available in case report form for each patient

Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.

Moderate or higher risk is defined as the observation of:

* More than 3 cores positive for cancer when considering all histological examination available during follow-up of study;
* or any Gleason primary or secondary pattern 4 or more;
* or at least one cancer core length greater than 5 mm;
* or PSA\>10ng/mL ( in 3 consecutive measures);
* or any T3 prostate cancer,
* or metastasis;
* or prostate cancer related death

Number of patients undergoing a radical treatment for prostate cancer such as: radical prostatectomy, radiotherapy, brachytherapy divided by the total number of patients.

Total number of biopsy sample containing tumor cells at the month 24 biopsy

Number of patients experiencing urinary incontinence, erectile dysfunction or urinary symptoms events divided by the total number of patients.

Number of patients experiencing adverse events divided by the total number of patients.

Number of patients experiencing severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death divided by the total number of patients.

Results of the International Index of Erectile Function (IIEF) and International Prostate Symptoms Score (IPSS) patients questionaires.

Steba Biotech S.A.

Behaviors and Mental Disorders

Quality of Life

TOOKAD® Soluble, lyophilized formulation,given at a dose of 4 mg/kg.

The VTP procedure will consist of a single, 10 minute infusion of 4mg/kg TOOKAD® Soluble. The drug will be activated by laser light at 753nm, with a fixed energy of 200Joules/cm, and a fixed power of 150mWatts/cm, delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance.

Jose Arturo Rodriguez Rivera, Dr

Mary Lol Ve Mendoza Medina, Dr

Luis Zegarra Montes, Professor

Ramón Rodriguez, Professor

The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.

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.

Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer

Study of the Efficacy,Safety and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Prostate Cancer

Number of patients with a negative biopsy.

Patients' reported outcome measures (PROMs) impairment: urinary symptoms using IPSS and erectile functions using IIEF. Quality of life using EQ5D will also be described

Total length of cancer present in all cores taken in any given biopsy session

Severe prostate cancer related events: cancer extension to T3, metastasis or prostate cancer-related death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.	NCT01310894	Prostate Cancer	TOOKAD® Soluble	18 Years -	Steba Biotech S.A.
Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.	NCT01310894	Prostate Cancer	TOOKAD® Soluble	18 Years -	Steba Biotech S.A.
Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer	NCT01875393	Prostate Cancer	TOOKAD® Soluble	18 Years -	Steba Biotech S.A.

Spots Global Cancer Trial Database for tookad® soluble