Study Using WST11 in Patients With Localized Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steba Biotech S.A.
ClinicalTrials.gov Identifier:
NCT00975429
First received: September 10, 2009
Last updated: February 21, 2013
Last verified: September 2012
  Purpose

The aim of this trial is to determine the optimal treatment conditions to achieve prostate cancer tumour ablation and to assess the effects of WST11-mediated Vascular-Targeted Photodynamic therapy (VTP) treatment in patients with localized prostate cancer.

The secondary objectives are to assess the safety and quality of life following WST11-mediated VTP treatment,to assess the effects,safety and quality of life following a second WST11-mediated VTP treatment; and to explore optimisation techniques to reduce the duration of the VTP procedure.


Condition Intervention Phase
Prostate Cancer
Drug: WST11
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vascular-Targeted Photodynamic Therapy Using WST11 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 lobes [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum PSA levels and PSA changes after treatment compared to baseline. [ Time Frame: Month 1, Month 3 & Month 6 ] [ Designated as safety issue: Yes ]
  • Volume of hypoperfusion area shown by dynamic gadolinium MRI. [ Time Frame: Day 7, Month 6 ] [ Designated as safety issue: Yes ]
  • Adverse events, ECG (12-lead),vital signs,clinical laboratory evaluations, physical examination. [ Time Frame: Screening-Month 6 ] [ Designated as safety issue: Yes ]
  • Quality of life IPSS; IIEF [ Time Frame: Month 1, Month 3 & Month 6 ] [ Designated as safety issue: Yes ]
  • Optimisation of the procedure [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: September 2009
Study Completion Date: August 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WST11 - 4mg (TOOKAD® Soluble)
4mg/kg Treatment with WST11-mediated VTP
Drug: WST11
The WST11-mediated VTP procedure will consist of a single IV administration of WST11 at a dose of 4mg/kg using a 753nm laser light at a fixed power (150mW/cm or 200mW/cm or 250mW/cm) and light energy (200J/cm or 300J/cm) delivered through transperineal interstitial optical fibers. The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound image guidance. The tumour location is established using transrectal biopsy and MR imaging. The number of fibers and the total light energy will be adapted to each patient based on a treatment planning proposed by treatment planning group.
Other Name: Treatment with WST11-mediated VTP
Experimental: WST11 - 6mg
6mg/kg Treatment with WST11-mediated VTP
Drug: WST11
The WST11-mediated VTP procedure will consist of a single IV administration of WST11 at a dose of 6mg/kg in patients using a 753nm laser light at a fixed power (150mW/cm or 200mW/cm or 250mW/cm ) and light energy (200J/cm or 300J/cm) delivered through transperineal interstitial optical fibers. The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound image guidance. The tumour location is established using transrectal biopsy and MR imaging. The number of fibers and the total light energy will be adapted to each patient based on a treatment planning proposed by treatment planning group.
Other Name: Treatment with WST11-mediated VTP

Detailed Description:

This trial is designed as a multicentre, phase II, open-labeled, multi-arm, single intravenous (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 4 or 6 mg/kg using 753nm laser light at a fixed power (150 mW/cm or 200 mW/cm or 250 mW/cm ) and light energy (200 J/cm or 300J/cm) delivered through transperineal interstitial optical fibers. The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound guidance. The tumour location is established using transrectal biopsy and MR imaging. The number of fibers and the total light energy will be adapted to each patient based on a treatment planning proposed by treatment planning group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men over 18 years of age;
  • 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;
  • Signed Informed Consent Form.

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.
  • 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;
  • 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
  • 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,). 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);
  • Patient with contra-indication to MRI (such as pace maker, metal prosthesis, etc.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975429

Locations
France
Centre Hospitalier Universitaire (CHU)
Angers, France
Hôpital Claude Huriez
Lille, France
Institut Mutualiste Montsouris(IMM)
Paris, France
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
United Kingdom
Frimley Park Hospital NHS Trust
Frimley, United Kingdom
University College London Hospital (UCLH)
London, United Kingdom
Kings College Hospital (KCH)
London, United Kingdom
Sponsors and Collaborators
Steba Biotech S.A.
Investigators
Principal Investigator: Mark Emberton, Professor University College London Hospital (UCLH)
Principal Investigator: Gordon MUIR, MD Kings College Hospital (KCH)
Principal Investigator: Neil BARBER, MD Frimley Park Hospital NHS Trust
Principal Investigator: Michel de Wildt, MD Catharina Ziekenhuis
Principal Investigator: Abdel-Rahmène AZZOUZI, Professor Centre Hospitalier Unniversitaire Angers(CHU)
Principal Investigator: Eric BARRET, MD Institut Mutualiste Montsouris (IMM)
Principal Investigator: Arnauld VILLERS, Professor Hôpital Claude Huriez
  More Information

No publications provided

Responsible Party: Steba Biotech S.A.
ClinicalTrials.gov Identifier: NCT00975429     History of Changes
Other Study ID Numbers: CLIN902 PCM203
Study First Received: September 10, 2009
Last Updated: February 21, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on July 23, 2014