Study of WST11 in Patients With Localized Prostate Cancer

April 17, 2016 updated by: Steba Biotech S.A.

Vascular-Targeted Photodynamic Therapy Using WST 11 in Patients With Localized Prostate Cancer

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;

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
  • France
      • Angers, France, 49933
        • Centre Hospitalier Universitaire
      • Dijon, France, 21079
        • Hôpital Bocage-CHU
      • Lille, France, 59037
        • Hôpital Claude Huriez
      • Paris, France, 75674
        • Institut Mutualiste Montsouris(IMM)
  • United Kingdom
      • Frimley, United Kingdom, GU16 7UJ
        • Frimley Park Hospital NHS Trust
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital(KCH)
      • London, United Kingdom, WC1E 5DB
        • Urology Directorate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • WST11-mediated VTP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Negative biopsy in the treated lobe
Time Frame: Month 6
Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 7; Month 1 ;3 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steba Biotech S.A.

Investigators

  • Principal Investigator: Mark EMBERTON, Professor, Urology Directorate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

June 26, 2008

First Submitted That Met QC Criteria

June 27, 2008

First Posted (Estimate)

June 30, 2008

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 17, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN801 PCM201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data are available in case report form for each patient

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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