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Study of WST11 in Patients With Localized Prostate Cancer
This study is currently recruiting participants.
Verified by Steba Biotech S.A., June 2009
First Received: June 26, 2008   Last Updated: September 10, 2009   History of Changes
Sponsor: Steba Biotech S.A.
Information provided by: Steba Biotech S.A.
ClinicalTrials.gov Identifier: NCT00707356
  Purpose

The aim of this clinical 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


Condition Intervention Phase
Localized Prostate Cancer
Drug: WST11
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: PHASE II Vascular-Targeted Photodynamic Therapy Using WST 11 in Patients With Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Steba Biotech S.A.:

Primary Outcome Measures:
  • Negative biopsy in the treated lobe [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
WST11: Experimental
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 to 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 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.

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 to 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707356

Locations
United Kingdom
Urology Directorate Recruiting
London, United Kingdom
Contact: Mark EMBERTON, Professor     + 44-20-7380-9194     markemberton@btinternet.com    
Principal Investigator: Mark EMBERTON, Professor            
Sponsors and Collaborators
Steba Biotech S.A.
Investigators
Principal Investigator: Mark EMBERTON, Professor Urology Directorate
  More Information

No publications provided

Responsible Party: STEBABIOTECH S.A ( Daniel ELKOUBI )
Study ID Numbers: CLIN801 PCM201
Study First Received: June 26, 2008
Last Updated: September 10, 2009
ClinicalTrials.gov Identifier: NCT00707356     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency;   Canada: Health Canada;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010