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.

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

Active surveillance is one of the management strategy in men who have intermediate risk localised prostate cancer

TOOKAD® -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®

Jonathan Coleman, MD

Multi-center, prospective, randomized controlled clinical trial that will compare two treatment methods (PGA with TOOKAD® VTP and Active Surveillance) for treating localized prostate cancer. The study will include criteria for evaluation, biopsy, eligibility, informed consent, subsequent management and decision making conducted based on data provided locally at each center that follow a set of standardized criteria.

The primary endpoint requires follow-up through 30 months, but all subjects will be followed for 72 months regardless of initiation of other local or systemic prostate cancer treatments, which will allow assessments of recurrence rates and morbidity after conversion to radical therapy, long-term safety and tolerability, as well as oncologic outcomes.

This is multi-center, prospective, randomized controlled phase III clinical trial that will compare two treatment methods (PGA with TOOKAD® VTP and Active Surveillance) for treating localized prostate cancer who meet the inclusion criteria will be approached for participation in the clinical study. Patients consenting to participate will be individually randomized to TOOKAD® VTP or Active Surveillance with a 1:1 ratio. Central randomization will be performed using an independent web-based allocation system. Randomization will be stratified by center using minimization. Ongoing assessment of patients in both arms will be balanced, including follow up examinations, PSA testing, MRI and biopsies at defined intervals.

Subjects in the experimental arm will receive the experimental treatment consisting of unilateral TOOKAD® VTP treatment applied to the index lobe containing pattern 4 cancer. The treatment will be administered under general anesthesia. Routine ultrasound examination in the operating room will be performed for morphometric description of the prostate and to facilitate accurate treatment planning and probe placement. Ultrasound will not be used for diagnostic purposes.

Evaluation of Efficacy of TOOKAD® (VTP) Versus Active Surveillance for Intermediate Risk Localized Prostate Cancer

An Evaluation of the Efficacy of Partial Gland Ablation (PGA) With TOOKAD® Vascular Targeted Photodynamic Therapy (VTP) Versus Active Surveillance for Men With Intermediate Risk Localized Prostate Cancer

To evaluate the difference in the rate of objective progression of cancer between men treated with TOOKAD -VTP and men managed with Active Surveillance for localized prostate cancer.

To confirm the differences between men treated with VTP and men managed with Active Surveillance in overall rate of conversion to radical local or systemic therapy

To confirm the differences between men treated with VTP and men managed with Active Surveillance in overall rate of conversion to radical local or systemic therapy following objective progression

To confirm the differences between men treated with VTP and men managed with Active Surveillance in the rate of biopsy progression in the index lobe (the lobe initially diagnosed with GG2 cancer) defined as:

* Any Grade Group 3 or higher cancer in a biopsy core of the index lobe
* Increase in total length of Gleason pattern 4 \>1mm above baseline and \>2mm in total length in a follow-up biopsy of the index lobe

The rate of clinical local or distant progression defined as any of the following:

* Clinical stage ≥ T3N0M0 cancer
* MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or "gross" ECE, or MRI lesion with \>10mm capsular contact) in an area with biopsy proven cancer.
* Seminal vesicle invasion, identified as "probable" or "definite," on DRE or MRI
* Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan.
* Metastatic disease
* Prostate cancer-specific death

The rate, severity, onset and duration of adverse events (AEs) and serious adverse events (SAEs)

The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being. Only Question GP5 will be assessed to determine bother related to adverse events.

The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective. Only Urinary Questions 61 - 65 will be assessed

The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective.Only Pain Question 48 will be assessed

The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective. Only Bowel Symptoms questions 17 and 18 will be assessed

The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective. Only Sexual Function questions 66-68 and 70-72 will be assessed

The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective.Only Anxiety question 54 will be assessed

The Memorial Anxiety Scale for Prostate Cancer (MAX-PC) has been developped to facilitate the identification and assessment of men with prostate cancer-related anxiety. This scale consists of three subscales that measure general prostate cancer anxiety, anxiety related to prostate specific antigen (PSA) levels in particular, and fear of recurrence. Only Anxiety Questions 15-18 will be assessed

The physician will evaluate the ease or difficulties of radical, local or systemic therapy after VTP procedure using a scale . The instrument to be used to assess feasibility of performing RT will be a 5-point Likert Scale.

The question may be similar to the following:

"What was the difficulty in performing radical treatment on the subject" and proposed anwers will be: None, Minimal, Moderate, Severe or Extreme

Safety recorded as incidence of Adverse events and Serious Adverse Events

Biochemical Response recorded as serum PSA change as absolute measurement in ng/dL and as percentage increase or decrease over time

Clinical recurrence recorded as physician recorded objective recurrence of tumor on physical exam or imaging.

Identification of the primary cause for conversion to radical treatment as assessed by physician:

* Pre-defined cancer progression
* Changes in clinical parameters in absence of objective progression (physicial examination findings, PSA, imaging (MRI, CT, PET), biopsy, or other tests to be documented such as genomic tests)
* Significant change in anxiety about prostate cancer (Defined as increase of last MAX-PC (Memorial Anxiety Scale for Prostate Cancer)-fear of recurrence score prior to conversion to radical therapy by 3 points or more vs. baseline) in the absence of objective progression or change in clinical parameters
* Patient preference in absence of objective progression, change in clinical parameters, or documented prostate cancer anxiety

Assessment of PSA level in predicting or monitoring oncologic outcomes of local recurrence, and local or systemic progression. PSA serum level to be recorded as ng/ml

Assessment of PSA density in predicting or monitoring oncologic outcomes of local recurrence, and local or systemic progression. PSA density is calculated as total PSA (ng/ml) divided by prostate volume (ml).

Assessment of PSA kinetics in predicting or monitoring oncologic outcomes of local recurrence, and local or systemic progression. PSA kinetics is evaluated as change in PSA serum level in ng/ml over time.

Change in size of initial lesion on MRI in cm3

Change in PIRADS v2 Score of initial lesion

Changes in imaging results to indicate potential progression of prostate cancer outside the prostate gland (Changes in level of suspicion for Extra Capsular Extension (ECE), Semical vesicle invasion (SVI), Lymph node (LN) metastases used to identify local recurrence, and local, regional or distant progression).

The WST11-mediated VTP procedure will consist of a single IV administration of WST11 at a dose of 4mg/kg using a 753nm laser light at a fixed power (150mW/cm or 200mW/cm or 250mW/cm) and light energy (200J/cm or 300J/cm) delivered through transperineal interstitial optical fibers. The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound image guidance. The tumour location is established using transrectal biopsy and MR imaging. The number of fibers and the total light energy will be adapted to each patient based on a treatment planning proposed by treatment planning group.

WST11

The WST11-mediated VTP procedure will consist of a single IV administration of WST11 at a dose of 6mg/kg in patients using a 753nm laser light at a fixed power (150mW/cm or 200mW/cm or 250mW/cm ) and light energy (200J/cm or 300J/cm) delivered through transperineal interstitial optical fibers. The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound image guidance. The tumour location is established using transrectal biopsy and MR imaging. The number of fibers and the total light energy will be adapted to each patient based on a treatment planning proposed by treatment planning group.

Gordon MUIR, MD

Neil BARBER, MD

Michel de Wildt, MD

Abdel-Rahmène AZZOUZI, Professor

Eric BARRET, MD

Arnauld VILLERS, Professor

The aim of this trial is to determine the optimal treatment conditions to achieve prostate cancer tumour ablation and to assess the effects of WST11-mediated Vascular-Targeted Photodynamic therapy (VTP) treatment in patients with localized prostate cancer.

The secondary objectives are to assess the safety and quality of life following WST11-mediated VTP treatment,to assess the effects,safety and quality of life following a second WST11-mediated VTP treatment; and to explore optimisation techniques to reduce the duration of the VTP procedure.

This trial is designed as a multicentre, phase II, open-labeled, multi-arm, single intravenous (IV) dose study. The patient is to receive general anesthesia. WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 4 or 6 mg/kg using 753nm laser light at a fixed power (150 mW/cm or 200 mW/cm or 250 mW/cm ) and light energy (200 J/cm or 300J/cm) delivered through transperineal interstitial optical fibers. The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound guidance. The tumour location is established using transrectal biopsy and MR imaging. The number of fibers and the total light energy will be adapted to each patient based on a treatment planning proposed by treatment planning group.

Study Using WST11 in Patients With Localized Prostate Cancer

Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer

WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2 mg/Kg,4 mg/Kg or 6 mg/kg, using 753 nm laser light at a fixed power (150mW/cm) and energy (200 J/cm) delivered through transperineal interstitial optical fibers. If deemed necessary and in consideration of the results of the patients treated with 200 J/cm, alternate power (200mW/cm) and alternate energy (300 J/cm) might be applied.The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound image guidance. The number of fibers and the total light energy will be adapted to each patient, taking into account the tumor localization and the volume of the prostate.

Mark EMBERTON, Professor

The aim of this clinical study is to determine the optimal treatment conditions to achieve prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in patients with localized prostate cancer.

The secondary objectives is to evaluate safety and quality of life ; to assess the pharmacokinetic parameters and to model the relationship between concentration and effects; and to assess the effects, the safety and quality of life of a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer after a first VTP;

This trial is designed as a multicentre, phase II, open-labeled, single intra-venous (IV) dose study. The patient is to receive general anesthesia. WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2 mg/Kg,4mg/Kg or 6 mg/kg, using 753 nm laser light at a fixed power (150mW/cm) and energy (200 J/cm) delivered through transperineal interstitial optical fibers. If deemed necessary and in consideration of the results of the patients treated with 200 J/cm, alternate power (200mW/cm) and alternate energy (300 J/cm) might be applied after Sponsor, Steering Committee and DSMB approval.The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound image guidance (using a brachytherapy like template). The tumor location is established using transrectal biopsy and MR imaging. The number of fibers and the total light energy will be adapted to each patient, taking into account the tumor localization and the volume of the prostate.

Study of WST11 in Patients With Localized Prostate Cancer

Vascular-Targeted Photodynamic Therapy Using WST 11 in Patients With Localized Prostate Cancer

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.

Prostatic Intraepithelial Neoplasia

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anti-Inflammatory Agents

Antineoplastic Agents

All Drugs and Chemicals

Other Dietary Supplements

Lycopene

Antioxidants

Protective Agents

Radiation-Protective Agents

Lycopene 30mg

Placebo

Peter H Gann, MD, ScD

The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.

The Effects of Lycopene on High Risk Prostatic Tissue

R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue

We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.

We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.

National Cancer Institute (NCI)

University of Illinois at Chicago

Professor and Director, Division of Pathology Research

Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)

Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Peter Gann

Tissue Biomarkers

Changes in Serum Biomarkers

Changes in Nuclear Morphometry

Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)

Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)

Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)

Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)

Overall Study

WST11-mediated-VTP The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers using 753 nm laser light at escalating fixed energy doses

The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance.

WST 11 -mediated -VTP

Samir Taneja, Professor

The aim of this study is to determine the optimal treatment conditions (WST11 dose and light energy dose) to achieve ablation in one lobe of the prostate and to evaluate the safety and quality of life of WST11 medicated Vascular-Targeted Photodynamic therapy (VTP) in men with localized prostate cancer.

This study is designed as a multicenter, phase I/II, prospective, open-labeled, single intravenous (IV) dose, clinical trial in patients with localized prostate cancer.

The study population will be men who have been offered curative therapy (radical prostatectomy; cryotherapy; brachytherapy; External Beam RadioTherapy (EBRT), and refused. Patients must have already had a previous biopsy showing a histologically proven carcinoma of the prostate. The identification and the location of the tumor will be done using both dynamic contrast Magnetic resonance Imaging (MRI) and biopsy.

Only unilateral treatment with WST11-medicated VTP will be performed during the study. Treatment will consist of a single, 10 minute, IV administration of WST11 at doses of 2mg/kg, 4 mg/kg or 6 mg/kg, followed by either light activation delivered through transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm or 300 J/cm by escalating power at each energy to 167 mW/cm or 250 mW/cm respectively. A brachytherapy-like template is used for the placement of the transparent implant catheters which are positioned in the prostate under transrectal ultrasound image guidance. The illumination fiber(s) are then inserted into the implant catheters.

If the safety profile for a given WST11 and light dose is acceptable, additional patients may be treated with multiple fibers at that WST11 treatment dose.

For cases where the Month 6 biopsy is positive, the patient will be offered the opportunity to be retreated with WST11

Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer

A Prospective, Multicenter Phase I/II Safety and Tolerability Study of Unilateral Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer

Arm/Group Title:

WST 11(TOOKAD® Soluble) Arm/Group Description To define the study drug and light dosage combination to achieve negative biopsy in the treated lobe

Number of patients who had a negative biopsy at Month-6

For each dose group, several pharmacokinetics parameters have been calculated.

The adjusted prostate necrosis percentage was defined as follows:

The Day 7 necrosis percentage is the proportion, expressed in %, of Day 7 prostate necrosis volume by planimetry in the treated lobe compared with half the prostate volume by planimetry, considering the average between the baseline volume and Day 7 volume;

The International Index of Erectile Functions questionnaire is 15 questions patients auto questionnaire. The results presented are those of the erectile function domain which comprise 6 questions. Possible scores range is 1 to 30 . Best score is 30, worst score is 1.

The International Prostate Symptom Score (IPSS) is a 7 questions patients auto-questionnaire about urinary symptoms. the possible scores range are 0 to 35 . Best score is 0 worst score is 35

WST 11-mediated-VTP The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers using 753 nm laser light at escalating fixed energy doses

WST 11 -mediated -VTP: The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance.

WST 11(TOOKAD® Soluble)

WST 11-mediated-VTP

WST 11 -mediated -VTP: The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance.

Age, Categorical

All 30 patients were males suffering from low risk prostate cancer.

Bertrand Gaillac International Project Leader

Positive

Negative

Number of patients with positives or négatives biopsies at the dose 2mg/Kg-200J/cm

2 mg/Kg-200 J/cm

Number of patients with positives or négatives biopsies at the dose 2mg/Kg-300J/cm

2 mg/Kg-300 J/cm

Number of patients with positives or négatives biopsies at the dose 4mg/Kg-200J/cm

4 mg/Kg-200 J/cm

Number of patients with positives or négatives biopsies at all doses/energies

All Doses/Energies

Prostate Biopsy

Number of patients with negative biopsies at the dose 2mg/Kg-200J/cm

Number of patients with negative biopsies at the dose 2mg/Kg-300J/cm

Number of patients with negative biopsies at the dose 4mg/Kg-200J/cm

Number of patients with negative biopsies at all doses/energies

Prostate Biopsies

Patients treated at the dose of 2 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.

2 mg/kg

Patients treated at the dose of 4 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.

4 mg/kg

Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.

Pharmacokinetic Parameters-Cmax

To evaluate the volume of necrosis observed on the 7-Day MRI in patients treated with 2 mg/kg-200J/cm

To evaluate the volume of necrosis observed on the 7-Day MRI in patients treated with 2 mg/kg-300J/cm

To evaluate the volume of necrosis observed on the 7-Day MRI in patients treated with 4 mg/kg-200J/cm

To evaluate the volume of necrosis observed on the 7-Day MRI in patients treated with all doses/energies

Percentage of Prostatic Necrosis at Day 7 as Observed on the 7-Day MRI

Baseline

Month 1

Month 3

Month 6

Month 12

To assess the QoL-IIEF in patients treated with the dose 2mg/Kg-200J/cm

To assess the QoL-IIEF in patients treated with the dose 2mg/Kg-300J/cm

To assess the QoL-IIEF in patients treated with the dose 4mg/Kg-200J/cm

To assess the QoL-IIEF in patients treated with all doses/energies

International Index of Erectile Functions (IIEF) Results

To assess the QoL-IPSS in patients treated with the dose 2mg/Kg-200J/cm

To assess the QoL-IPSS in patients treated with the dose 2mg/Kg-300J/cm

To assess the QoL-IPSS in patients treated with the dose 4mg/Kg-200J/cm

To assess the QoL-IPSS in patients treated with all doses/energies

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.
Evaluation of Efficacy of TOOKAD® (VTP) Versus Active Surveillance for Intermediate Risk Localized Prostate Cancer	NCT04225299	Localized Prost...	TOOKAD®	18 Years -	Steba Biotech S.A.
Study Using WST11 in Patients With Localized Prostate Cancer	NCT00975429	Prostate Cancer	WST11 WST11	18 Years -	Steba Biotech S.A.
Study of WST11 in Patients With Localized Prostate Cancer	NCT00707356	Prostate Cancer	WST11	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.
Study Using WST11 in Patients With Localized Prostate Cancer	NCT00975429	Prostate Cancer	WST11 WST11	18 Years -	Steba Biotech S.A.
The Effects of Lycopene on High Risk Prostatic Tissue	NCT01443026	Intraepithelial... Prostatic Neopl...	Lycopene 30mg Placebo	40 Years -	University of Illinois at Chicago
Study Using WST11 in Patients With Localized Prostate Cancer	NCT00975429	Prostate Cancer	WST11 WST11	18 Years -	Steba Biotech S.A.
The Effects of Lycopene on High Risk Prostatic Tissue	NCT01443026	Intraepithelial... Prostatic Neopl...	Lycopene 30mg Placebo	40 Years -	University of Illinois at Chicago
Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer	NCT00946881	Prostate Cancer	WST 11 -mediate...	18 Years -	Steba Biotech S.A.
Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer	NCT00946881	Prostate Cancer	WST 11 -mediate...	18 Years -	Steba Biotech S.A.

Spots Global Cancer Trial Database for male urogenital disease