Study of WST11 in Patients With Localized Prostate Cancer

NCT00707356 | Completed Phase 2 DMC

• 1 other identifier: CLIN801 PCM201
• Study Type: interventional
• Target: 42
• Locations: 3 countries
• Sites: 8

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;

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 lobe

  Month 6

Secondary Outcomes (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

  Day 7; Month 1 ;3 and 6

Study Arms (1)

WST11(TOOKAD® Soluble)

EXPERIMENTAL

Treatment with WST11-mediated VTP

Drug: WST11

Interventions

WST11 DRUG

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.

Also known as: WST11-mediated VTP

WST11(TOOKAD® Soluble)

Eligibility Criteria

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

You may qualify if:

• 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;

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.
• 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;

Sponsors & Collaborators

• Steba Biotech S.A.: lead

Study Sites (8)

University Health Network-Princess Margaret Hospital

Toronto, M5G 2M9, Canada

Location

Centre Hospitalier Universitaire

Angers, 49933, France

Location

Hôpital Bocage-CHU

Dijon, 21079, France

Location

Hôpital Claude Huriez

Lille, 59037, France

Location

Institut Mutualiste Montsouris(IMM)

Paris, 75674, France

Location

Frimley Park Hospital NHS Trust

Frimley, GU16 7UJ, United Kingdom

Location

Kings College Hospital(KCH)

London, SE5 9RS, United Kingdom

Location

Urology Directorate

London, WC1E 5DB, United Kingdom

Location

Related Publications (5)

• Moore CM, Azzouzi AR, Barret E, Villers A, Muir GH, Barber NJ, Bott S, Trachtenberg J, Arumainayagam N, Gaillac B, Allen C, Schertz A, Emberton M. Determination of optimal drug dose and light dose index to achieve minimally invasive focal ablation of localised prostate cancer using WST11-vascular-targeted photodynamic (VTP) therapy. BJU Int. 2015 Dec;116(6):888-96. doi: 10.1111/bju.12816. Epub 2015 Apr 21.

  PMID: 24841929 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

• Colin P, Estevez JP, Betrouni N, Ouzzane A, Puech P, Leroy X, Biserte J, Villers A, Mordon S. [Photodynamic therapy and prostate cancer]. Prog Urol. 2011 Feb;21(2):85-92. doi: 10.1016/j.purol.2010.07.018. Epub 2010 Sep 17. French.

  PMID: 21296274 DERIVED

MeSH Terms

Conditions

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

Interventions

padeliporfin

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark EMBERTON, Professor

  Urology Directorate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: July 1, 2012
• Last Updated: April 19, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (4); CA (1); GB (3)