Prostate CancerPhase 2/3NCT00312442
Phase II/III Study of WST09 in Prostate Cancer After Radiation Therapy
A Phase 2/3 study testing Treatment with WST09 Vascular Photodynamic therapy in people with Prostate Cancer, run by STEBA France at 1 site in Canada.
Trial summary
The aim of this clinical trial is to evaluate the efficacy and safety of the WST09-mediated vascular-targeted photodynamic therapy (VTP) in patients with localized prostate cancer recurrent after external radiation therapy or temporary (High Dose Rate, or HDR) brachytherapy. 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?
- Treatment with WST09 Vascular Photodynamic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Dec 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- Histologically proven localized prostate cancer after receiving external radiation therapy;
Who cannot join
- Patients unwilling or unable to give informed consent; Patients who received or are receiving chemotherapy; Patients previously treated with HIFU, cryotherapy, other salvage treatments, or with a trans-urethral resection of the prostate (TURP); Patients whose previous radiation therapy caused extensive cystitis and/or proctitis.
- Patients suspected of Disseminated Intravascular Coagulation (DIC). Patients with prior history of coronary artery disease, angina pectoris, myocardial infarction, coronary angioplasty or coronary artery bypass graft, severe valvulopathy, cardiac failure, artrial fibrillation and / or sustained arrhythmia.
- Patients whose cardiac status does not allow general anesthesia. Patients with history of thromboses or thrombo-embolisms. Patients with history of stroke or transient ischemic attack.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy
The aim of this clinical trial is to evaluate the efficacy and safety of the WST09-mediated vascular-targeted photodynamic therapy (VTP) in patients with localized prostate cancer recurrent after external radiation therapy or temporary (High Dose Rate, or HDR) brachytherapy.
Read the detailed description
This is a multicentre, open labelled, phase II/III, 6-month clinical trial with an additional follow-up at Month 12, aiming to determine the efficacy and tolerability of the WST09-mediated VTP treatment. This treatment consists of an I.V. infusion of WST09 (2 mg/kg), in combination with per-cutaneous interstitial illumination using laser light (wavelength at 763nm) delivered through optical fibres positioned through the perineum in the prostatic lobes.
Patients who are eligible to participate in the study must have a clinically diagnosed positive biopsy of the prostate (up to stage T2b-N0-M0) diagnosed after external radiotherapy or temporary brachytherapy (no seeds), and present with increasing PSA levels on three consecutive occasions (at least 3 months apart) post-radiation treatment.
- Conditions
- Prostate Cancer
- Being tested
- Treatment with WST09 Vascular Photodynamic therapy
- Keywords
- Prostate cancer after radiation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with WST09 Vascular Photodynamic therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| WST 09 | Experimental | Treatment with WST09-mediated VTP Receives: Drug: Treatment with WST09 Vascular Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate biopsy results at Month 6 after treatment.
Measured: 6 months
Secondary outcomes (6)
Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP.
Measured: 6 months
PSA levels taken periodically for 1 year after the procedure
Measured: Month 1,3,6 and 1 year
Hypoperfusion according to MRI at Week 1 after the procedure.
Measured: 1 week and Month 6
Calculated PSA velocity before and after WST09-mediated VTP.
Measured: Month 1,3,6 and 1 year
Nadir of the PSA after the WST09-mediated VTP compared with the nadir of PSA after radiation therapy
Measured: Month 1,3,6 and 1 year
To assess the safety and tolerability of WST09-mediated VTP treatment in this patient population
The evaluation of safety will be based on reported adverse events, changes in vital signs and laboratory tests from the Treatment Visit until the study is completed.
Measured: Day1,Day 7, Month1,3,6,and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionJul 2008
- Study completionDec 2009
Why it stopped: STEBA decided to develop WST11 that is soluble in aqueous solutions. The property of WST 11 make it safer and better candidate for therapeutic applications.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- STEBA France
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John Trachtenberg, MD FRCS(C), Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312442
- Sponsor's protocol ID
- HEC/WST0512 66N/WST 2.21
- Status last verified
- May 2010
- First submitted
- 30 Mar 2006
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy
- ClinicalTrials.gov ID
- NCT00312442
- Acronym / sponsor ID
- HEC/WST0512 66N/WST 2.21
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer after radiation therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: STEBA decided to develop WST11 that is soluble in aqueous solutions. The property of WST 11 make it safer and better candidate for therapeutic applications.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- STEBA FranceIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Apr 2006 (estimated)
- Results
- Not posted in the source record
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 clinical trial is to evaluate the efficacy and safety of the WST09-mediated vascular-targeted photodynamic therapy (VTP) in patients with localized prostate cancer recurrent after external radiation therapy or temporary (High Dose Rate, or HDR) brachytherapy.
Detailed description
This is a multicentre, open labelled, phase II/III, 6-month clinical trial with an additional follow-up at Month 12, aiming to determine the efficacy and tolerability of the WST09-mediated VTP treatment. This treatment consists of an I.V. infusion of WST09 (2 mg/kg), in combination with per-cutaneous interstitial illumination using laser light (wavelength at 763nm) delivered through optical fibres positioned through the perineum in the prostatic lobes.
Patients who are eligible to participate in the study must have a clinically diagnosed positive biopsy of the prostate (up to stage T2b-N0-M0) diagnosed after external radiotherapy or temporary brachytherapy (no seeds), and present with increasing PSA levels on three consecutive occasions (at least 3 months apart) post-radiation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WST 09 | Experimental | Drug: Treatment with WST09 Vascular Photodynamic therapyTreatment with WST09-mediated VTP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically proven localized prostate cancer after receiving external radiation therapy;
Key exclusion criteria (3 listed)
- Patients unwilling or unable to give informed consent; Patients who received or are receiving chemotherapy; Patients previously treated with HIFU, cryotherapy, other salvage treatments, or with a trans-urethral resection of the prostate (TURP); Patients whose previous radiation therapy caused extensive cystitis and/or proctitis.
- Patients suspected of Disseminated Intravascular Coagulation (DIC). Patients with prior history of coronary artery disease, angina pectoris, myocardial infarction, coronary angioplasty or coronary artery bypass graft, severe valvulopathy, cardiac failure, artrial fibrillation and / or sustained arrhythmia.
- Patients whose cardiac status does not allow general anesthesia. Patients with history of thromboses or thrombo-embolisms. Patients with history of stroke or transient ischemic attack.
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 |
|---|---|---|
| Treatment with WST09 Vascular Photodynamic therapy | Drug | WST 09 |
Primary outcome
Prostate biopsy results at Month 6 after treatment.
Time frame: 6 months
6 secondary outcomes
Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP.
Time frame: 6 months
PSA levels taken periodically for 1 year after the procedure
Time frame: Month 1,3,6 and 1 year
Hypoperfusion according to MRI at Week 1 after the procedure.
Time frame: 1 week and Month 6
Calculated PSA velocity before and after WST09-mediated VTP.
Time frame: Month 1,3,6 and 1 year
Nadir of the PSA after the WST09-mediated VTP compared with the nadir of PSA after radiation therapy
Time frame: Month 1,3,6 and 1 year
To assess the safety and tolerability of WST09-mediated VTP treatment in this patient population
Time frame: Day1,Day 7, Month1,3,6,and 12
Results and safety
The study was stopped early (reason given: STEBA decided to develop WST11 that is soluble in aqueous solutions. The property of WST 11 make it safer and better candidate for therapeutic applications.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
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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.
John Trachtenberg, MD FRCS(C) principal investigator
University Health Network, Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Treatment with WST09 Vascular Photodynamic therapy in people with Prostate Cancer, run by STEBA France at 1 site in Canada.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: STEBA decided to develop WST11 that is soluble in aqueous solutions. The property of WST 11 make it safer and better candidate for therapeutic applications.). Results are not available in the source record.
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 results at Month 6 after treatment. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2010.