Prostate CancerPhase 1/2NCT00946881
Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer
A Phase 1/2 study testing WST 11 -mediated -VTP in people with Prostate Cancer, run by Steba Biotech S.A. at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- WST 11 -mediated -VTP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2009to Aug 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Diagnosed with localized, prostate cancer and who have been offered curative therapy (radical prostatectomy; cryotherapy; brachytherapy; External Beam RadioTherapy (EBRT), and refused
- Localized prostate cancer stage T1C up to T2A based on biopsy performed at least 6 weeks prior to enrollment
- Gleason score ≤ 3+3 with ≤50% of sampled cores positive, and each positive core having a tumour length of ≤5 mm
- Prostate Specific Antigen (PSA) < 10 ng/mL
- No prior treatment for prostate cancer
- Signed Informed Consent Form
Who cannot join
- Any condition or history of illness or surgery that, in the opinion of the investigator and/or the Sponsor, might confound the results of the study or pose additional risks to the patient.
- All patients whose current pre-operative cardiac evaluation does not show their fitness for a procedure requiring general anesthesia;
- Patients with a prior history of viral or alcoholic hepatitis, and other patients felt to be at risk for hepatotoxicity including concomitant use of potentially hepatotoxic medications or dietary supplements;
- Patients with a history of inflammatory bowel disease or other factors which may increase the risk of fistula formation;
- Patients who have received any hormonal manipulation (excluding 5-alpha reductase inhibitors) or androgen supplements within the previous 6 months;
- Patients previously treated by radiation therapy (external therapy or brachytherapy) or chemotherapy or any therapy for prostate cancer;
Show all 23Show fewer
- Patients who have received or are receiving chemotherapy for prostate carcinoma or other significant cancer;
- Patients who have undergone previous TURP (trans-urethral resection of the prostate);
- Patients with a history of urethral stricture disease
- Patients with a history of acute urinary retention
- Patients who are currently (within 10 days before the treatment procedure) receiving any medications having potential photosensitizing effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin)
- Patients who are currently receiving anticoagulant drugs (within 10 days before the treatment procedure) (e.g.: coumadin, warfarin)
- Patient who stopped long term treatment of acetylsalicylic acid (aspirin) or other anti platelets agents within 10 days prior to the treatment procedure;
- Patient suspected of Disseminated Intravascular Coagulation (DIC) as defined by the presence of three out of the five following criteria: platelets decrease, increase of PT, increase of aPTT, fibrinogen decrease, D-Dimer increase; from the normal laboratory ranges;
- Patient with a history of vasculitis or collagen vascular disease;
- History of non compliance with medical therapy and medical recommendations or an unwillingness or inability to complete patient self-administered questionnaires;
- Participation in a clinical study or receipt of an investigational treatment within the past 3 months;
- A history of porphyria;
- A history of sun hypersensitivity or photosensitive dermatitis;
- Renal disorders (blood creatinine > 1.5 x ULN) or known post mictional residue > 150cc
- Hepatic disorders (transaminases > ULN, bilirubin > ULN, GGT > ULN). In case of slight abnormalities, another exam could be performed. If the results are within normal ranges, then the patient can be included;
- Hematological disorders (white cells < 2500/mm3, neutrophils < 1500/mm3, platelets, < 140.000/mm3, Hb ≤ 10 g/dL);
- Patients with contra-indication to MRI (such as pace maker, metal prosthesis, etc.).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Midtown Urology & Midtown Urology Surgical Center
Atlanta, Georgia, 30308
UCLA - Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
NYU Urology Associates
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Washington University School of Medicine- Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: A Prospective, Multicenter Phase I/II Safety and Tolerability Study of Unilateral Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer
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.
Read the detailed description
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
- Conditions
- Prostate Cancer
- Being tested
- WST 11 -mediated -VTP
- Keywords
- Prostatic disease, genital neoplasm, male, Urogenital neoplasm, Genital disease, male, Male urogenital disease, Neoplasms, Neoplasm by site, prostatic neoplasm, Carcinoma
- Medical subject headings
- Prostatic Neoplasms, Prostatic Diseases, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male Urogenital Diseases, Neoplasms, Neoplasms by Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WST 11 -mediated -VTPDrug
Also called TOOKAD Soluble
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.
| Study group | Role | What they receive |
|---|---|---|
| WST11 (TOOKAD® Soluble) | Experimental | 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 Receives: Drug: WST 11 -mediated -VTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 6
Prostate Biopsies
Number of patients who had a negative biopsy at Month-6
Measured: Month-6
Secondary outcomes (6)
Pharmacokinetic Parameters-Cmax
For each dose group, several pharmacokinetics parameters have been calculated.
Measured: 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;
Measured: 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.
Measured: 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
Measured: Month 1, Month 3 , Month 6 , Month 12
Pharmacokinetic Parameters-Tmax
For each dose group, several pharmacokinetics parameters have been calculated.
Measured: 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.
Measured: T0, 5 min,10 min, 4 h, 8 h, post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steba Biotech S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Taneja, Professor, Principal investigator, Department of Urology, New York University Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946881
- Sponsor's protocol ID
- CLIN901 PCM202
- Status last verified
- Oct 2017
- First submitted
- 24 Jul 2009
- Last updated
- 7 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: The data are available in case report form for each patient
Publications
Taneja SS, Bennett J, Coleman J, Grubb R, Andriole G, Reiter RE, Marks L, Azzouzi AR, Emberton M. Final Results of a Phase I/II Multicenter Trial of WST11 Vascular Targeted Photodynamic Therapy for Hemi-Ablation of the Prostate in Men with Unilateral Low Risk Prostate Cancer Performed in the United States. J Urol. 2016 Oct;196(4):1096-104. doi: 10.1016/j.juro.2016.05.113. Epub 2016 Jun 9.
PubMed 27291652Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD(R) Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.
PubMed 25712310
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Phase I/II Safety and Tolerability Study of Unilateral Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00946881
- Acronym / sponsor ID
- CLIN901 PCM202
- Conditions
- Prostate Cancer
- Keywords
- Prostatic disease, genital neoplasm, male, Urogenital neoplasm, Genital disease, male, Male urogenital disease, Neoplasms, Neoplasm by site
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Steba Biotech S.A.University, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WST11 (TOOKAD® Soluble) | Experimental | Drug: WST 11 -mediated -VTPWST11-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age
- Diagnosed with localized, prostate cancer and who have been offered curative therapy (radical prostatectomy; cryotherapy; brachytherapy; External Beam RadioTherapy (EBRT), and refused
- Localized prostate cancer stage T1C up to T2A based on biopsy performed at least 6 weeks prior to enrollment
- Gleason score ≤ 3+3 with ≤50% of sampled cores positive, and each positive core having a tumour length of ≤5 mm
- Prostate Specific Antigen (PSA) < 10 ng/mL
Key exclusion criteria (23 listed)
- Any condition or history of illness or surgery that, in the opinion of the investigator and/or the Sponsor, might confound the results of the study or pose additional risks to the patient.
- All patients whose current pre-operative cardiac evaluation does not show their fitness for a procedure requiring general anesthesia;
- Patients with a prior history of viral or alcoholic hepatitis, and other patients felt to be at risk for hepatotoxicity including concomitant use of potentially hepatotoxic medications or dietary supplements;
- Patients with a history of inflammatory bowel disease or other factors which may increase the risk of fistula formation;
- Patients who have received any hormonal manipulation (excluding 5-alpha reductase inhibitors) or androgen supplements within the previous 6 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WST 11 -mediated -VTPAlso: TOOKAD SolubleThe 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. | Drug | WST11 (TOOKAD® Soluble) |
Primary outcome
Prostate Biopsy
Time frame: Month 6
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
Prostate Biopsies
Time frame: Month-6
Number of patients who had a negative biopsy at Month-6
6 secondary outcomes
Pharmacokinetic Parameters-Cmax
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
Time frame: Day 7
International Index of Erectile Functions (IIEF) Results
Time frame: Month 1-Month 3- Month 6- Month 12
International Prostate Symptom Score (IPSS) Results
Time frame: Month 1, Month 3 , Month 6 , Month 12
Pharmacokinetic Parameters-Tmax
Time frame: T0, 5 min,10 min, 4 h, 8 h, post dose
Pharmacokinetic Parameters -T1/2
Time frame: T0, 5 min,10 min, 4 h, 8 h, post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27291652Taneja SS, Bennett J, Coleman J, Grubb R, Andriole G, Reiter RE, Marks L, Azzouzi AR, Emberton M. Final Results of a Phase I/II Multicenter Trial of WST11 Vascular Targeted Photodynamic Therapy for Hemi-Ablation of the Prostate in Men with Unilateral Low Risk Prostate Cancer Performed in the United States. J Urol. 2016 Oct;196(4):1096-104. doi: 10.1016/j.juro.2016.05.113. Epub 2016 Jun 9.
- Derived from this study: PubMed 25712310Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD(R) Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.
- Individual participant dataSharing planned: No. The data are available in case report form for each patient
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Taneja, Professor principal investigator
Department of Urology, New York University Cancer Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WST 11 -mediated -VTP in people with Prostate Cancer, run by Steba Biotech S.A. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate Biopsy (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00946881, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.