A Phase 1/2 interventional study of WST 11 -mediated -VTP in Prostate Cancer, sponsored by Steba Biotech S.A.. Completed at 5 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Steba Biotech S.A. · Phase 1/2, Interventional, and Treatment
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
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Steba Biotech S.A. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: 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.
Also known as: TOOKAD Soluble
Prostate Biopsy
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
Prostate Biopsies
Number of patients who had a negative biopsy at Month-6
Time frame: Month-6
Pharmacokinetic Parameters-Cmax
For each dose group, several pharmacokinetics parameters have been calculated.
Time frame: T0, 5 min,10 min, 4 h, 8 h, post dose
Percentage of Prostatic Necrosis at Day 7 as Observed on the 7-Day MRI
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
International Index of Erectile Functions (IIEF) Results
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
International Prostate Symptom Score (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
Time frame: Month 1, Month 3 , Month 6 , Month 12
Pharmacokinetic Parameters-Tmax
For each dose group, several pharmacokinetics parameters have been calculated.
Time frame: T0, 5 min,10 min, 4 h, 8 h, post dose
Pharmacokinetic Parameters -T1/2
For each dose group, several pharmacokinetics parameters have been calculated.
Time frame: T0, 5 min,10 min, 4 h, 8 h, post dose
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.
| Milestone | WST 11(TOOKAD® Soluble) |
|---|---|
| Started | 30 |
| Completed | 28 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Patient relocated to another state | 1 |
| Milestone | WST 11(TOOKAD® Soluble) |
|---|---|
| Started | 8 |
| Completed | 7 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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
| participants | 2 mg/Kg-200 J/cm | 2 mg/Kg-300 J/cm | 4 mg/Kg-200 J/cm | All Doses/Energies |
|---|---|---|---|---|
| Positive | 0 | 3 | 8 | 11 |
| Negative | 3 | 3 | 13 | 19 |
Number of patients who had a negative biopsy at Month-6
| Participants | 2 mg/Kg-200 J/cm | 2 mg/Kg-300 J/cm | 4 mg/Kg-200 J/cm | All Doses/Energies |
|---|---|---|---|---|
| Prostate Biopsies | 3 | 3 | 13 | 19 |
For each dose group, several pharmacokinetics parameters have been calculated.
| ng/mL | 2 mg/kg | 4 mg/kg |
|---|---|---|
| Pharmacokinetic Parameters-Cmax | 30883.83 ± 11583.07 | 57102.87 ± 14849.50 |
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;
| percentage of prostatic necrosis | 2 mg/Kg-200 J/cm | 2 mg/Kg-300 J/cm | 4 mg/Kg-200 J/cm | All Doses/Energies |
|---|---|---|---|---|
| Percentage of Prostatic Necrosis at Day 7 as Observed on the 7-Day MRI | 46.9 ± 41.6 | 13.8 ± 16.3 | 61.1 ± 25.3 | 52.3 ± 31.9 |
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.
| units on a scale | 2 mg/Kg-200 J/cm | 2 mg/Kg-300 J/cm | 4 mg/Kg-200 J/cm | All Doses/Energies |
|---|---|---|---|---|
| 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 |
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
| units on a scale | 2 mg/Kg-200 J/cm | 2 mg/Kg-300 J/cm | 4 mg/Kg-200 J/cm | All Doses/Energies |
|---|---|---|---|---|
| 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 |
For each dose group, several pharmacokinetics parameters have been calculated.
| hours | 2 mg/kg | 4 mg/kg |
|---|---|---|
| Pharmacokinetic Parameters-Tmax | 0.43 ± 0.61 | 0.25 ± 0.22 |
For each dose group, several pharmacokinetics parameters have been calculated.
| hours | 2 mg/kg | 4 mg/kg |
|---|---|---|
| Pharmacokinetic Parameters -T1/2 | 1.25 ± 0.90 | 1.69 ± 1.11 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| WST 11(TOOKAD® Soluble) | — | 0/30 (0%) | 25/30 (83.3%) |
| Event | WST 11(TOOKAD® Soluble) |
|---|---|
| Renal and urinary disordersRenal and urinary disorders | 19/30 |
| Reproductive system and breast disordersReproductive system and breast disorders | 16/30 |
| Gastrointestinal disorderGastrointestinal disorders | 9/30 |
| InvestigationsInvestigations | 9/30 |
| General disordersGeneral disorders | 5/30 |
| Musculoskeletal disordersMusculoskeletal and connective tissue disorders | 5/30 |
| Skin disordersSkin and subcutaneous tissue disorders | 5/30 |
| Injury, poisoningInjury, poisoning and procedural complications | 3/30 |
| Nervous system disordersNervous system disorders | 2/30 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 2/30 |
All 30 patients were males suffering from low risk prostate cancer.
| Age, Categorical(Participants) | WST 11(TOOKAD® Soluble) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 13 |
| Age, Continuous(years) | WST 11(TOOKAD® Soluble) |
|---|---|
| Mean | 61.6 ± 7.8 |
| Sex: Female, Male(Participants) | WST 11(TOOKAD® Soluble) |
|---|---|
| Female | 0 |
| Male | 30 |
| Region of Enrollment(participants) | WST 11(TOOKAD® Soluble) |
|---|---|
| United States | 30 |
Plan to share: No — The data are available in case report form for each patient
The record gives a start of Jul 2009, a primary completion of Jul 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2017, 5 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Padeliporfin
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