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

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ClinicalTrials.gov Identifier: NCT00946881
Recruitment Status : Completed
First Posted : July 27, 2009
Results First Posted : November 6, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Steba Biotech S.A.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: WST 11 -mediated -VTP
Enrollment 30
Recruitment Details

Thirty patients were included in the study by five different centers in the US. All 30 patients received the entire VTP procedure (first treatment phase).

Two of them discontinued the study prior to Month 12. Eight patients who had positive biopsies at Month 6 entered in the retreatment phase. Only 7 of them actually received retreatment.

Pre-assignment Details  
Arm/Group Title WST 11(TOOKAD® Soluble)
Hide Arm/Group Description

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.

Period Title: First Treatment
Started 30
Completed 28
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Patient relocated to another state             1
Period Title: Retreatment
Started 8
Completed 7
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title WST 11(TOOKAD® Soluble)
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
All 30 patients were males suffering from low risk prostate cancer.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  56.7%
>=65 years
13
  43.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
61.6  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
0
   0.0%
Male
30
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Prostate Biopsy
Hide Description

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

Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 mg/Kg-200 J/cm 2 mg/Kg-300 J/cm 4 mg/Kg-200 J/cm All Doses/Energies
Hide Arm/Group Description:
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-200J/cm
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-300J/cm
Number of patients with positives or négatives biopsies at the dose 4mg/Kg-200J/cm
Number of patients with positives or négatives biopsies at all doses/energies
Overall Number of Participants Analyzed 3 6 21 30
Measure Type: Number
Unit of Measure: participants
Positive 0 3 8 11
Negative 3 3 13 19
2.Primary Outcome
Title Prostate Biopsies
Hide Description Number of patients who had a negative biopsy at Month-6
Time Frame Month-6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 mg/Kg-200 J/cm 2 mg/Kg-300 J/cm 4 mg/Kg-200 J/cm All Doses/Energies
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 3 6 21 30
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
3
  50.0%
13
  61.9%
19
  63.3%
3.Secondary Outcome
Title Pharmacokinetic Parameters-Cmax
Hide Description For each dose group, several pharmacokinetics parameters have been calculated.
Time Frame T0, 5 min,10 min, 4 h, 8 h, post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.
Arm/Group Title 2 mg/kg 4 mg/kg
Hide Arm/Group Description:
Patients treated at the dose of 2 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
Patients treated at the dose of 4 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
Overall Number of Participants Analyzed 9 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
30883.83  (11583.07) 57102.87  (14849.50)
4.Secondary Outcome
Title Percentage of Prostatic Necrosis at Day 7 as Observed on the 7-Day MRI
Hide Description

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;

Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 mg/Kg-200 J/cm 2 mg/Kg-300 J/cm 4 mg/Kg-200 J/cm All Doses/Energies
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 3 6 21 30
Mean (Standard Deviation)
Unit of Measure: percentage of prostatic necrosis
46.9  (41.6) 13.8  (16.3) 61.1  (25.3) 52.3  (31.9)
5.Secondary Outcome
Title International Index of Erectile Functions (IIEF) Results
Hide Description 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.
Time Frame Month 1-Month 3- Month 6- Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 mg/Kg-200 J/cm 2 mg/Kg-300 J/cm 4 mg/Kg-200 J/cm All Doses/Energies
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 3 6 21 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 21.33  (4.73) 13.17  (8.70) 18.80  (7.88) 17.90  (7.99)
Month 1 14.33  (10.97) 14.00  (8.92) 13.65  (8.98) 13.79  (8.80)
Month 3 19.33  (4.04) 14.17  (10.26) 14.84  (7.91) 15.18  (8.04)
Month 6 19.33  (1.53) 15.00  (9.47) 15.29  (7.46) 15.63  (7.46)
Month 12 21.67  (2.52) 6.25  (10.50) 15.29  (8.48) 14.48  (9.26)
6.Secondary Outcome
Title International Prostate Symptom Score (IPSS) Results
Hide Description 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
Time Frame Month 1, Month 3 , Month 6 , Month 12
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Hide Analysis Population Description
IPSS results
Arm/Group Title 2 mg/Kg-200 J/cm 2 mg/Kg-300 J/cm 4 mg/Kg-200 J/cm All Doses/Energies
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 3 6 21 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 10.67  (8.02) 11.67  (7.31) 8.65  (6.82) 9.48  (6.88)
Month 1 9.67  (9.87) 11.00  (6.00) 10.62  (6.34) 10.60  (6.38)
Month 3 4.67  (5.69) 8.83  (4.83) 8.00  (5.36) 7.83  (5.22)
Month 6 9.67  (8.62) 8.50  (4.23) 6.71  (4.80) 7.37  (5.02)
Month 12 7.33  (4.04) 15.5  (8.89) 7.93  (4.50) 9.29  (6.02)
7.Secondary Outcome
Title Pharmacokinetic Parameters-Tmax
Hide Description For each dose group, several pharmacokinetics parameters have been calculated.
Time Frame T0, 5 min,10 min, 4 h, 8 h, post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.
Arm/Group Title 2 mg/kg 4 mg/kg
Hide Arm/Group Description:
Patients treated at the dose of 2 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
Patients treated at the dose of 4 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
Overall Number of Participants Analyzed 9 20
Mean (Standard Deviation)
Unit of Measure: hours
0.43  (0.61) 0.25  (0.22)
8.Secondary Outcome
Title Pharmacokinetic Parameters -T1/2
Hide Description For each dose group, several pharmacokinetics parameters have been calculated.
Time Frame T0, 5 min,10 min, 4 h, 8 h, post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.
Arm/Group Title 2 mg/kg 4 mg/kg
Hide Arm/Group Description:
Patients treated at the dose of 2 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
Patients treated at the dose of 4 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
Overall Number of Participants Analyzed 9 20
Mean (Standard Deviation)
Unit of Measure: hours
1.25  (0.90) 1.69  (1.11)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title WST 11(TOOKAD® Soluble)
Hide Arm/Group Description

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.

All-Cause Mortality
WST 11(TOOKAD® Soluble)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
WST 11(TOOKAD® Soluble)
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
WST 11(TOOKAD® Soluble)
Affected / at Risk (%) # Events
Total   25/30 (83.33%)    
Gastrointestinal disorders   
Gastrointestinal disorder * 1  9/30 (30.00%)  10
General disorders   
General disorders * 1  5/30 (16.67%)  5
Injury, poisoning and procedural complications   
Injury, poisoning * 1  3/30 (10.00%)  3
Investigations   
Investigations * 1  9/30 (30.00%)  12
Musculoskeletal and connective tissue disorders   
Musculoskeletal disorders * 1  5/30 (16.67%)  6
Nervous system disorders   
Nervous system disorders * 1  2/30 (6.67%)  2
Renal and urinary disorders   
Renal and urinary disorders * 1  19/30 (63.33%)  45
Reproductive system and breast disorders   
Reproductive system and breast disorders * 1  16/30 (53.33%)  25
Respiratory, thoracic and mediastinal disorders   
Respiratory, thoracic and mediastinal disorders * 1  2/30 (6.67%)  2
Skin and subcutaneous tissue disorders   
Skin disorders * 1  5/30 (16.67%)  5
Vascular disorders   
Vascular disorders * 1  2/30 (6.67%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bertrand Gaillac International Project Leader
Organization: STEBA Biotech
Phone: + 33 974197905
EMail: b.gaillac@stebabiotech.com
Layout table for additonal information
Responsible Party: Steba Biotech S.A.
ClinicalTrials.gov Identifier: NCT00946881     History of Changes
Other Study ID Numbers: CLIN901 PCM202
First Submitted: July 24, 2009
First Posted: July 27, 2009
Results First Submitted: April 20, 2016
Results First Posted: November 6, 2017
Last Update Posted: February 12, 2019