Study Using WST11 in Patients With Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975429
• Other study ID #: CLIN902 PCM203
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2009
• Last updated: April 27, 2015
• Start date: September 2009
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: Steba Biotech S.A.
• Contact: n/a
• Is FDA regulated: No
• 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
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: August 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire (CHU)	Angers
France	Hôpital Claude Huriez	Lille
France	Institut Mutualiste Montsouris(IMM)	Paris
Netherlands	Catharina Ziekenhuis	Eindhoven
United Kingdom	Frimley Park Hospital NHS Trust	Frimley
United Kingdom	Kings College Hospital (KCH)	London
United Kingdom	University College London Hospital (UCLH)	London

Sponsors (1)

Lead Sponsor	Collaborator
Steba Biotech S.A.

Countries where clinical trial is conducted

France,  Netherlands,  United Kingdom, 

References & Publications (1)

Azzouzi AR, Barret E, Moore CM, Villers A, Allen C, Scherz A, Muir G, de Wildt M, Barber NJ, Lebdai S, Emberton M. TOOKAD(®) Soluble vascular-targeted photodynamic (VTP) therapy: determination of optimal treatment conditions and assessment of effects in p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative biopsy in the treated lobes		Month 6	No
Secondary	Serum PSA levels and PSA changes after treatment compared to baseline.		Month 1, Month 3 & Month 6	Yes
Secondary	Volume of hypoperfusion area shown by dynamic gadolinium MRI.		Day 7, Month 6	Yes
Secondary	Adverse events, ECG (12-lead),vital signs,clinical laboratory evaluations, physical examination.		Screening-Month 6	Yes
Secondary	Quality of life IPSS; IIEF		Month 1, Month 3 & Month 6	Yes
Secondary	Optimisation of the procedure		Day 1	No