Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer

NCT00946881 | Completed Phase 1 Results DMC

• 1 other identifier: CLIN901 PCM202
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

The aim of this study is to determine the optimal treatment conditions (WST11 dose and light energy dose) to achieve ablation in one lobe of the prostate and to evaluate the safety and quality of life of WST11 medicated Vascular-Targeted Photodynamic therapy (VTP) in men with localized prostate cancer.

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 (2)

• Prostate Biopsy

  Arm/Group Title: WST 11(TOOKAD® Soluble) Arm/Group Description To define the study drug and light dosage combination to achieve negative biopsy in the treated lobe

  Month 6

• Prostate Biopsies

  Number of patients who had a negative biopsy at Month-6

  Month-6

Secondary Outcomes (6)

• Pharmacokinetic Parameters-Cmax

  T0, 5 min,10 min, 4 h, 8 h, post dose

• Percentage of Prostatic Necrosis at Day 7 as Observed on the 7-Day MRI

  Day 7

• International Index of Erectile Functions (IIEF) Results

  Month 1-Month 3- Month 6- Month 12

• International Prostate Symptom Score (IPSS) Results

  Month 1, Month 3 , Month 6 , Month 12

• Pharmacokinetic Parameters-Tmax

  T0, 5 min,10 min, 4 h, 8 h, post dose

Study Arms (1)

WST11 (TOOKAD® Soluble)

EXPERIMENTAL

WST11-mediated-VTP The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers using 753 nm laser light at escalating fixed energy doses

Drug: WST 11 -mediated -VTP

Interventions

WST 11 -mediated -VTP DRUG

The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance.

Also known as: TOOKAD Soluble

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:

• At least 18 years of age
• Diagnosed with localized, prostate cancer and who have been offered curative therapy (radical prostatectomy; cryotherapy; brachytherapy; External Beam RadioTherapy (EBRT), and refused
• Localized prostate cancer stage T1C up to T2A based on biopsy performed at least 6 weeks prior to enrollment
• Gleason score ≤ 3+3 with ≤50% of sampled cores positive, and each positive core having a tumour length of ≤5 mm
• Prostate Specific Antigen (PSA) \< 10 ng/mL
• No prior treatment for prostate cancer
• 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;
• Patients who have received any hormonal manipulation (excluding 5-alpha reductase inhibitors) or androgen supplements within the previous 6 months;
• Patients previously treated by radiation therapy (external therapy or brachytherapy) or chemotherapy or any therapy for prostate cancer;
• Patients who have received or are receiving chemotherapy for prostate carcinoma or other significant cancer;
• Patients who have undergone previous TURP (trans-urethral resection of the prostate);
• Patients with a history of urethral stricture disease
• Patients with a history of acute urinary retention
• Patients who are currently (within 10 days before the treatment procedure) receiving any medications having potential photosensitizing effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin)
• Patients who are currently receiving anticoagulant drugs (within 10 days before the treatment procedure) (e.g.: coumadin, warfarin)
• Patient who stopped long term treatment of acetylsalicylic acid (aspirin) or other anti platelets agents within 10 days prior to the treatment procedure;
• Patient suspected of Disseminated Intravascular Coagulation (DIC) as defined by the presence of three out of the five following criteria: platelets decrease, increase of PT, increase of aPTT, fibrinogen decrease, D-Dimer increase; from the normal laboratory ranges;
• Patient with a history of vasculitis or collagen vascular disease;

Sponsors & Collaborators

• Steba Biotech S.A.: lead

Study Sites (5)

UCLA - Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Midtown Urology & Midtown Urology Surgical Center

Atlanta, Georgia, 30308, United States

Location

Washington University School of Medicine- Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

NYU Urology Associates

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (2)

• Taneja SS, Bennett J, Coleman J, Grubb R, Andriole G, Reiter RE, Marks L, Azzouzi AR, Emberton M. Final Results of a Phase I/II Multicenter Trial of WST11 Vascular Targeted Photodynamic Therapy for Hemi-Ablation of the Prostate in Men with Unilateral Low Risk Prostate Cancer Performed in the United States. J Urol. 2016 Oct;196(4):1096-104. doi: 10.1016/j.juro.2016.05.113. Epub 2016 Jun 9.

  PMID: 27291652 RESULT

• 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

MeSH Terms

Conditions

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

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

Results Point of Contact

• Title: Bertrand Gaillac International Project Leader
• Organization: STEBA Biotech

b.gaillac@stebabiotech.com

+ 33 974197905

Study Officials

• Samir Taneja, Professor

  Department of Urology, New York University Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2009
• First Posted: July 27, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 7, 2024
• Results First Posted: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)