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Study of WST11 in Patients With Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00707356
Recruitment Status : Completed
First Posted : June 30, 2008
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Steba Biotech S.A.

Study Description
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Brief Summary:

The aim of this clinical study is to determine the optimal treatment conditions to achieve prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in patients with localized prostate cancer.

The secondary objectives is to evaluate safety and quality of life ; to assess the pharmacokinetic parameters and to model the relationship between concentration and effects; and to assess the effects, the safety and quality of life of a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer after a first VTP;


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: WST11 Phase 2

Detailed Description:
This trial is designed as a multicentre, phase II, open-labeled, single intra-venous (IV) dose study. The patient is to receive general anesthesia. WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2 mg/Kg,4mg/Kg or 6 mg/kg, using 753 nm laser light at a fixed power (150mW/cm) and energy (200 J/cm) delivered through transperineal interstitial optical fibers. If deemed necessary and in consideration of the results of the patients treated with 200 J/cm, alternate power (200mW/cm) and alternate energy (300 J/cm) might be applied after Sponsor, Steering Committee and DSMB approval.The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound image guidance (using a brachytherapy like template). The tumor location is established using transrectal biopsy and MR imaging. The number of fibers and the total light energy will be adapted to each patient, taking into account the tumor localization and the volume of the prostate.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vascular-Targeted Photodynamic Therapy Using WST 11 in Patients With Localized Prostate Cancer
Study Start Date : September 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: WST11(TOOKAD® Soluble)
Treatment with WST11-mediated VTP
 Drug: WST11
WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2 mg/Kg,4 mg/Kg or 6 mg/kg, using 753 nm laser light at a fixed power (150mW/cm) and energy (200 J/cm) delivered through transperineal interstitial optical fibers. If deemed necessary and in consideration of the results of the patients treated with 200 J/cm, alternate power (200mW/cm) and alternate energy (300 J/cm) might be applied.The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound image guidance. The number of fibers and the total light energy will be adapted to each patient, taking into account the tumor localization and the volume of the prostate.
Other Name: WST11-mediated VTP


Outcome Measures
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Primary Outcome Measures :
  1. Negative biopsy in the treated lobe [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. Volume of the hypoperfusion area shown by dynamic gadolinium MRI . Serum PSA levels and PSA changes . Adverse Events, ECG (12-lead), vital signs, clinical laboratory evaluations, physical examination Quality of Life:•IPSS •IIEF [ Time Frame: Day 7; Month 1 ;3 and 6 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with prostate cancer and eligible for active surveillance;
  • No prior treatment for prostate cancer;
  • Prostate Cancer Stage up to cT2b - N0/Nx - M0/Mx (rT2c and pT2c are acceptable);
  • Gleason score ≤ 3+3 For patients characterized with prostate mapping (transperineal template guided biopsy at 5mm intervals) a secondary pattern 4 is acceptable provided that it is not present in more than 3 cores from each side of the prostate and is no more than 3 mm cancer core length.
  • PSA < 10 ng/mL;

Exclusion Criteria:

  • 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.
  • 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;
  • 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;
  • Patient with contra-indication to MRI (such as pace maker, metal prosthesis, etc.);
  • All patients whose current pre-operative cardiac evaluation does not show their fitness for a procedure requiring general anesthesia;
  • Patients with a history of inflammatory bowel disease or other factors which may increase the risk of fistula formation;
  • Men who have received any hormonal manipulation (excluding 5-alpha reductase inhibitors) or androgen supplements within the previous 6 months;
  • Men previously treated by radiation therapy (external therapy or brachytherapy) or chemotherapy or any therapy for prostate cancer;
  • Men who have received or are receiving chemotherapy for prostate carcinoma or other significant cancer;
  • Men who have undergone previous TURP (trans-urethral resection of the prostate);
  • Men who are currently receiving any medications having potential photosensitizing effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin);
  • Men who are receiving anticoagulant drugs (e.g.: coumadin, warfarin)
  • Patient who stopped long term treatment of acetylsalicylic acid (aspirin) or other anti platelets agents less than 15 days before the procedure;
  • Patient suspected of Disseminated Intravascular Coagulation (DIC) as defined by the presence of three out of the five following criteria: platelets <LLN, PT >ULN,aPTT >ULN, fibrinogen<LLN, D-Dimer >ULN;
  • 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). In case of slight abnormalities, another exam should 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 < 8 g/dl);
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707356


Locations
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Canada
University Health Network-Princess Margaret Hospital
Toronto, Canada, M5G 2M9
France
Centre Hospitalier Universitaire
Angers, France, 49933
Hôpital Bocage-CHU
Dijon, France, 21079
Hôpital Claude Huriez
Lille, France, 59037
Institut Mutualiste Montsouris(IMM)
Paris, France, 75674
United Kingdom
Frimley Park Hospital NHS Trust
Frimley, United Kingdom, GU16 7UJ
Kings College Hospital(KCH)
London, United Kingdom, SE5 9RS
Urology Directorate
London, United Kingdom, WC1E 5DB
Sponsors and Collaborators
Steba Biotech S.A.
Investigators
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Principal Investigator: Mark EMBERTON, Professor Urology Directorate
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Steba Biotech S.A.
ClinicalTrials.gov Identifier: NCT00707356    
Other Study ID Numbers: CLIN801 PCM201
First Posted: June 30, 2008    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data are available in case report form for each patient
Keywords provided by Steba Biotech S.A.:
Prostatic disease
genital neoplasm, male
Urogenital neoplasm
Genital disease
male
 Male urogenital disease
Neoplasms
Neoplasm by site
prostatic neoplasm
Carcinoma
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases