Study Using WST11 in Patients With Localized Prostate Cancer

NCT00975429 | Completed Phase 2

• 1 other identifier: CLIN902 PCM203
• Study Type: interventional
• Target: 86
• Locations: 3 countries
• Sites: 7

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostatic Disease; Genital neoplasm, male; Urogenital neoplasm; Genital disease,male; Male urogenital disease; Neoplasms; Neoplasm by site; Prostatic neoplasm; Carcinoma

Outcome Measures

Primary Outcomes (1)

• Negative biopsy in the treated lobes

  Month 6

Secondary Outcomes (5)

• Serum PSA levels and PSA changes after treatment compared to baseline.

  Month 1, Month 3 & Month 6

• Volume of hypoperfusion area shown by dynamic gadolinium MRI.

  Day 7, Month 6

• Adverse events, ECG (12-lead),vital signs,clinical laboratory evaluations, physical examination.

  Screening-Month 6

• Quality of life IPSS; IIEF

  Month 1, Month 3 & Month 6

• Optimisation of the procedure

  Day 1

Study Arms (2)

WST11 - 4mg (TOOKAD® Soluble)

EXPERIMENTAL

4mg/kg Treatment with WST11-mediated VTP

Drug: WST11

WST11 - 6mg

EXPERIMENTAL

6mg/kg Treatment with WST11-mediated VTP

Drug: WST11

Interventions

WST11 DRUG

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.

Also known as: Treatment with WST11-mediated VTP

WST11 - 4mg (TOOKAD® Soluble)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Steba Biotech S.A.: lead

Study Sites (7)

Centre Hospitalier Universitaire (CHU)

Angers, France

Location

Hôpital Claude Huriez

Lille, France

Location

Institut Mutualiste Montsouris(IMM)

Paris, France

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Frimley Park Hospital NHS Trust

Frimley, United Kingdom

Location

Kings College Hospital (KCH)

London, United Kingdom

Location

University College London Hospital (UCLH)

London, United Kingdom

Location

Related Publications (4)

• Azzouzi AR, Barret E, Moore CM, Villers A, Allen C, Scherz A, Muir G, de Wildt M, Barber NJ, Lebdai S, Emberton M. TOOKAD((R)) Soluble vascular-targeted photodynamic (VTP) therapy: determination of optimal treatment conditions and assessment of effects in patients with localised prostate cancer. BJU Int. 2013 Oct;112(6):766-74. doi: 10.1111/bju.12265.

  PMID: 24028764 RESULT

• Azzouzi AR, Lebdai S, Benzaghou F, Stief C. Vascular-targeted photodynamic therapy with TOOKAD(R) Soluble in localized prostate cancer: standardization of the procedure. World J Urol. 2015 Jul;33(7):937-44. doi: 10.1007/s00345-015-1535-2. Epub 2015 Mar 19.

  PMID: 25786708 DERIVED

• Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD(R) Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.

  PMID: 25712310 DERIVED

• Lebdai S, Villers A, Barret E, Nedelcu C, Bigot P, Azzouzi AR. Feasibility, safety, and efficacy of salvage radical prostatectomy after Tookad(R) Soluble focal treatment for localized prostate cancer. World J Urol. 2015 Jul;33(7):965-71. doi: 10.1007/s00345-015-1493-8. Epub 2015 Jan 23.

  PMID: 25614256 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Neoplasms; Neoplasms by Site; Carcinoma

Interventions

padeliporfin; Therapeutics

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: August 1, 2012
• Last Updated: April 28, 2015

Record last verified: 2012-09

Locations

GB (3); NL (1); FR (3)