Safety and Tolerability 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:
NCT00946881
First received: July 24, 2009
Last updated: February 21, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: WST 11 -mediated -VTP
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Phase I/II Safety and Tolerability Study of Unilateral 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:
  • To define the study drug and light dosage combination to achieve negative biopsy in the treated lobe. [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
  • To determine the safety and tolerability effects, including toxicity, of WST11-mediated VTP treatment in patients with localized prostate cancer [ Time Frame: Day 1, Day 2, Day 4, Week 1, Month 1,Month 3,Month 6, Month 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the quality of life following WST11 VTP treatment in patients with localized prostate cancer [ Time Frame: Month 1, Month 3 , Month 6 , Month 12 ] [ Designated as safety issue: No ]
  • To assess the pharmacokinetic parameters of WST-11 infusion, using serum and urine analysis [ Time Frame: Day 1, Day 2,Day 4 ] [ Designated as safety issue: No ]
  • To assess the pharmacodynamics (the VTP effects) [ Time Frame: Week 1, Month 6, Month 12 ] [ Designated as safety issue: No ]
  • To evaluate the volume of necrosis observed on the 7-Day MRI and correlate this observed necrosis with the biopsy outcome at Month 6. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • To assess the safety and efficacy of a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer. [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: July 2009
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WST 11(TOOKAD® Soluble)
WST 11-mediated-VTP
Drug: WST 11 -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 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.

Detailed Description:

This study is designed as a multicenter, phase I/II, prospective, open-labeled, single intravenous (IV) dose, clinical trial in patients with localized prostate cancer.

The study population will be men who have been offered curative therapy (radical prostatectomy; cryotherapy; brachytherapy; EBRT), and refused. Patients must have already had a previous biopsy showing a histologically proven carcinoma of the prostate. The identification and the location of the tumor will be done using both dynamic contrast MRI and biopsy.

Only unilateral treatment with WST11-medicated VTP will be performed during the study. Treatment will consist of a single, 10 minute, IV administration of WST11 at doses of 2mg/kg, 4 mg/kg or 6 mg/kg, followed by either light activation delivered through transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm or 300 J/cm by escalating power at each energy to 167 mW/cm or 250 mW/cm respectively. A brachytherapy-like template is used for the placement of the transparent implant catheters which are positioned in the prostate under transrectal ultrasound image guidance. The illumination fiber(s) are then inserted into the implant catheters.

If the safety profile for a given WST11 and light dose is acceptable, additional patients (up to 3) may be treated with multiple fibers at that WST11 treatment dose.

For cases where the Month 6 biopsy is positive, the patient will be offered the opportunity to be retreated with WST11

  Eligibility

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

Inclusion Criteria:

  • At least 18 years of age
  • Diagnosed with localized, prostate cancer and who have been offered curative therapy (radical prostatectomy; cryotherapy; brachytherapy; 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
  • PSA < 10 ng/mL
  • No prior treatment for prostate cancer
  • 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;
  • 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;
  • 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, GGT > ULN). In case of slight abnormalities, another exam could 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 ≤ 10 g/dL);
  • Patients 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: NCT00946881

Locations
United States, California
UCLA - Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
United States, Georgia
Midtown Urology & Midtown Urology Surgical Center
Atlanta, Georgia, United States, 30308
United States, Missouri
Washington University School of Medicine- Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New York
NYU Urology Associates
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York,, New York, United States, 10021
Sponsors and Collaborators
Steba Biotech S.A.
Investigators
Principal Investigator: Samir Taneja, Professor Department of Urology, New York University Cancer Institute
  More Information

No publications provided

Responsible Party: Steba Biotech S.A.
ClinicalTrials.gov Identifier: NCT00946881     History of Changes
Other Study ID Numbers: CLIN901 PCM202
Study First Received: July 24, 2009
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

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 28, 2014