Trial Outcomes & Findings for Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer (NCT NCT00946881)
NCT ID: NCT00946881
Last Updated: 2024-02-07
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Month 6
Results posted on
2024-02-07
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
First Treatment
STARTED
|
30
|
|
First Treatment
COMPLETED
|
28
|
|
First Treatment
NOT COMPLETED
|
2
|
|
Retreatment
STARTED
|
8
|
|
Retreatment
COMPLETED
|
7
|
|
Retreatment
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
First Treatment
Withdrawal by Subject
|
1
|
|
First Treatment
Patient relocated to another state
|
1
|
|
Retreatment
Withdrawal by Subject
|
1
|
Baseline Characteristics
Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
WST 11(TOOKAD® Soluble)
n=30 Participants
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
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=39 Participants
|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 7.8 • n=39 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Month 6Arm/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
Outcome measures
| Measure |
2 mg/Kg-200 J/cm
n=3 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-200J/cm
|
2 mg/Kg-300 J/cm
n=6 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-300J/cm
|
4 mg/Kg-200 J/cm
n=21 Participants
Number of patients with positives or négatives biopsies at the dose 4mg/Kg-200J/cm
|
All Doses/Energies
n=30 Participants
Number of patients with positives or négatives biopsies at all doses/energies
|
|---|---|---|---|---|
|
Prostate Biopsy
Positive
|
0 participants
|
3 participants
|
8 participants
|
11 participants
|
|
Prostate Biopsy
Negative
|
3 participants
|
3 participants
|
13 participants
|
19 participants
|
PRIMARY outcome
Timeframe: Month-6Number of patients who had a negative biopsy at Month-6
Outcome measures
| Measure |
2 mg/Kg-200 J/cm
n=3 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-200J/cm
|
2 mg/Kg-300 J/cm
n=6 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-300J/cm
|
4 mg/Kg-200 J/cm
n=21 Participants
Number of patients with positives or négatives biopsies at the dose 4mg/Kg-200J/cm
|
All Doses/Energies
n=30 Participants
Number of patients with positives or négatives biopsies at all doses/energies
|
|---|---|---|---|---|
|
Prostate Biopsies
|
3 Participants
|
3 Participants
|
13 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: T0, 5 min,10 min, 4 h, 8 h, post dosePopulation: Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.
For each dose group, several pharmacokinetics parameters have been calculated.
Outcome measures
| Measure |
2 mg/Kg-200 J/cm
n=9 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-200J/cm
|
2 mg/Kg-300 J/cm
n=20 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-300J/cm
|
4 mg/Kg-200 J/cm
Number of patients with positives or négatives biopsies at the dose 4mg/Kg-200J/cm
|
All Doses/Energies
Number of patients with positives or négatives biopsies at all doses/energies
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters-Cmax
|
30883.83 ng/mL
Standard Deviation 11583.07
|
57102.87 ng/mL
Standard Deviation 14849.50
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7The 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;
Outcome measures
| Measure |
2 mg/Kg-200 J/cm
n=3 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-200J/cm
|
2 mg/Kg-300 J/cm
n=6 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-300J/cm
|
4 mg/Kg-200 J/cm
n=21 Participants
Number of patients with positives or négatives biopsies at the dose 4mg/Kg-200J/cm
|
All Doses/Energies
n=30 Participants
Number of patients with positives or négatives biopsies at all doses/energies
|
|---|---|---|---|---|
|
Percentage of Prostatic Necrosis at Day 7 as Observed on the 7-Day MRI
|
46.9 percentage of prostatic necrosis
Standard Deviation 41.6
|
13.8 percentage of prostatic necrosis
Standard Deviation 16.3
|
61.1 percentage of prostatic necrosis
Standard Deviation 25.3
|
52.3 percentage of prostatic necrosis
Standard Deviation 31.9
|
SECONDARY outcome
Timeframe: Month 1-Month 3- Month 6- Month 12The 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.
Outcome measures
| Measure |
2 mg/Kg-200 J/cm
n=3 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-200J/cm
|
2 mg/Kg-300 J/cm
n=6 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-300J/cm
|
4 mg/Kg-200 J/cm
n=21 Participants
Number of patients with positives or négatives biopsies at the dose 4mg/Kg-200J/cm
|
All Doses/Energies
n=30 Participants
Number of patients with positives or négatives biopsies at all doses/energies
|
|---|---|---|---|---|
|
International Index of Erectile Functions (IIEF) Results
Baseline
|
21.33 units on a scale
Standard Deviation 4.73
|
13.17 units on a scale
Standard Deviation 8.70
|
18.80 units on a scale
Standard Deviation 7.88
|
17.90 units on a scale
Standard Deviation 7.99
|
|
International Index of Erectile Functions (IIEF) Results
Month 1
|
14.33 units on a scale
Standard Deviation 10.97
|
14.00 units on a scale
Standard Deviation 8.92
|
13.65 units on a scale
Standard Deviation 8.98
|
13.79 units on a scale
Standard Deviation 8.80
|
|
International Index of Erectile Functions (IIEF) Results
Month 3
|
19.33 units on a scale
Standard Deviation 4.04
|
14.17 units on a scale
Standard Deviation 10.26
|
14.84 units on a scale
Standard Deviation 7.91
|
15.18 units on a scale
Standard Deviation 8.04
|
|
International Index of Erectile Functions (IIEF) Results
Month 6
|
19.33 units on a scale
Standard Deviation 1.53
|
15.00 units on a scale
Standard Deviation 9.47
|
15.29 units on a scale
Standard Deviation 7.46
|
15.63 units on a scale
Standard Deviation 7.46
|
|
International Index of Erectile Functions (IIEF) Results
Month 12
|
21.67 units on a scale
Standard Deviation 2.52
|
6.25 units on a scale
Standard Deviation 10.50
|
15.29 units on a scale
Standard Deviation 8.48
|
14.48 units on a scale
Standard Deviation 9.26
|
SECONDARY outcome
Timeframe: Month 1, Month 3 , Month 6 , Month 12Population: IPSS results
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
Outcome measures
| Measure |
2 mg/Kg-200 J/cm
n=3 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-200J/cm
|
2 mg/Kg-300 J/cm
n=6 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-300J/cm
|
4 mg/Kg-200 J/cm
n=21 Participants
Number of patients with positives or négatives biopsies at the dose 4mg/Kg-200J/cm
|
All Doses/Energies
n=30 Participants
Number of patients with positives or négatives biopsies at all doses/energies
|
|---|---|---|---|---|
|
International Prostate Symptom Score (IPSS) Results
Baseline
|
10.67 units on a scale
Standard Deviation 8.02
|
11.67 units on a scale
Standard Deviation 7.31
|
8.65 units on a scale
Standard Deviation 6.82
|
9.48 units on a scale
Standard Deviation 6.88
|
|
International Prostate Symptom Score (IPSS) Results
Month 1
|
9.67 units on a scale
Standard Deviation 9.87
|
11.00 units on a scale
Standard Deviation 6.00
|
10.62 units on a scale
Standard Deviation 6.34
|
10.60 units on a scale
Standard Deviation 6.38
|
|
International Prostate Symptom Score (IPSS) Results
Month 3
|
4.67 units on a scale
Standard Deviation 5.69
|
8.83 units on a scale
Standard Deviation 4.83
|
8.00 units on a scale
Standard Deviation 5.36
|
7.83 units on a scale
Standard Deviation 5.22
|
|
International Prostate Symptom Score (IPSS) Results
Month 6
|
9.67 units on a scale
Standard Deviation 8.62
|
8.50 units on a scale
Standard Deviation 4.23
|
6.71 units on a scale
Standard Deviation 4.80
|
7.37 units on a scale
Standard Deviation 5.02
|
|
International Prostate Symptom Score (IPSS) Results
Month 12
|
7.33 units on a scale
Standard Deviation 4.04
|
15.5 units on a scale
Standard Deviation 8.89
|
7.93 units on a scale
Standard Deviation 4.50
|
9.29 units on a scale
Standard Deviation 6.02
|
SECONDARY outcome
Timeframe: T0, 5 min,10 min, 4 h, 8 h, post dosePopulation: Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.
For each dose group, several pharmacokinetics parameters have been calculated.
Outcome measures
| Measure |
2 mg/Kg-200 J/cm
n=9 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-200J/cm
|
2 mg/Kg-300 J/cm
n=20 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-300J/cm
|
4 mg/Kg-200 J/cm
Number of patients with positives or négatives biopsies at the dose 4mg/Kg-200J/cm
|
All Doses/Energies
Number of patients with positives or négatives biopsies at all doses/energies
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters-Tmax
|
0.43 hours
Standard Deviation 0.61
|
0.25 hours
Standard Deviation 0.22
|
—
|
—
|
SECONDARY outcome
Timeframe: T0, 5 min,10 min, 4 h, 8 h, post dosePopulation: Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.
For each dose group, several pharmacokinetics parameters have been calculated.
Outcome measures
| Measure |
2 mg/Kg-200 J/cm
n=9 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-200J/cm
|
2 mg/Kg-300 J/cm
n=20 Participants
Number of patients with positives or négatives biopsies at the dose 2mg/Kg-300J/cm
|
4 mg/Kg-200 J/cm
Number of patients with positives or négatives biopsies at the dose 4mg/Kg-200J/cm
|
All Doses/Energies
Number of patients with positives or négatives biopsies at all doses/energies
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters -T1/2
|
1.25 hours
Standard Deviation 0.90
|
1.69 hours
Standard Deviation 1.11
|
—
|
—
|
Adverse Events
WST 11(TOOKAD® Soluble)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
WST 11(TOOKAD® Soluble)
n=30 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
30.0%
9/30 • Number of events 10 • 1 year
|
|
General disorders
General disorders
|
16.7%
5/30 • Number of events 5 • 1 year
|
|
Injury, poisoning and procedural complications
Injury, poisoning
|
10.0%
3/30 • Number of events 3 • 1 year
|
|
Investigations
Investigations
|
30.0%
9/30 • Number of events 12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorders
|
16.7%
5/30 • Number of events 6 • 1 year
|
|
Nervous system disorders
Nervous system disorders
|
6.7%
2/30 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders
|
63.3%
19/30 • Number of events 45 • 1 year
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
53.3%
16/30 • Number of events 25 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
6.7%
2/30 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin disorders
|
16.7%
5/30 • Number of events 5 • 1 year
|
|
Vascular disorders
Vascular disorders
|
6.7%
2/30 • Number of events 2 • 1 year
|
Additional Information
Bertrand Gaillac International Project Leader
STEBA Biotech
Phone: + 33 974197905
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60