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 Neoplasms, Male

Genital Diseases, Male

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.

WST11

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

The data are available in case report form for each patient

Steba Biotech S.A.

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

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of WST11 in Patients With Localized Prostate Cancer	NCT00707356	Prostate Cancer	WST11	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.
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 genital disease