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NCT01310894 · CITED IN SOURCE DOCUMENTS

Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2019-07-11

The aims of this study are: * to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and * to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: Subjects will be eligible for inclusion in the study if all of the following criteria are met: 1. Low risk prostate cancer diagnosed using one transrectal ultrasound guided biopsy (TRUS)using from 10 to 24 cores performed less than 12 months prior to enrolment, and showing the following: * Gleason 3 + 3 prostate adenocarcinoma as a maximum, * Two (2) to three (3) cores positive for cancer * A maximum cancer core length of 5 mm in any core. 2. Cancer clinical stage up to T2a (pathological or radiological up to T2c disease permitted) 3. Serum prostate specific antigen (PSA) of 10 ng/mL or less 4. Prostate volume equal or greater than 25 cc and less than 70 cc. 5. Male subjects aged 18 years or older. Exclusion Criteria: Subjects will not be eligible for the study if meeting any of the following criteria: 1. Unwillingness to accept randomisation to either of the two arms of the study 2. Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy. 3. Any surgical intervention for benign prostatic hypertrophy 4. Life expectancy less than 10 years. 5. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure. 6. Participation in another clinical study or recipient of an investigational product within 1 month of study entry. 7. Subject unable to understand the patient's information document, to give consent or complete the study tasks. 8. Subject in custody and or in residence in a nursing home or rehabilitation facility 9. Contra-indication to Magnetic resonance Imaging (MRI) (e.g., pacemaker, history of allergic reaction to gadolinium), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis) 10. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the TOOKAD® Soluble VTP procedure.
healthy Volunteers
false
minimum Age
18 Years
sex
MALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    TOOKAD® Soluble, lyophilized formulation, given at a dose of 4mg/Kg.
    intervention Names
    1. Drug: TOOKAD® Soluble
    label
    TOOKAD® Soluble
    type
    EXPERIMENTAL
  2. description
    Active surveillance is one of the management strategy in men who have low-risk prostate cancer
    label
    Active Surveillance
    type
    NO_INTERVENTION
interventions
  1. arm Group Labels
    1. TOOKAD® Soluble
    description
    TOOKAD® Soluble-VTP procedure will consist of an IntraVenous (IV) administration to patients using a 753nm laser light at a fixed power of 150mW/cm and a fixed energy at 200J/cm delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance
    name
    TOOKAD® Soluble
    other Names
    1. WST11
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
413
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.
    measure
    Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.
    time Frame
    Month 24
  2. description
    Moderate or higher risk is defined as the observation of: * More than 3 cores positive for cancer when considering all histological examination available during follow-up of study; * or any Gleason primary or secondary pattern 4 or more; * or at least one cancer core length greater than 5 mm; * or PSA\>10ng/mL ( in 3 consecutive measures); * or any T3 prostate cancer, * or metastasis; * or prostate cancer related death
    measure
    Co-primary endpoint 'B': Difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer.
    time Frame
    Over 24 months follow-up.
secondary Outcomes
  1. description
    Number of patients undergoing a radical treatment for prostate cancer such as: radical prostatectomy, radiotherapy, brachytherapy divided by the total number of patients.
    measure
    The rate of additional prostate cancer radical therapy
    time Frame
    Over 24 months follow-up
  2. description
    Total number of biopsy sample containing tumor cells at the month 24 biopsy
    measure
    Total number of cores positive for cancer
    time Frame
    Month 24
  3. description
    Number of patients experiencing urinary incontinence, erectile dysfunction or urinary symptoms events divided by the total number of patients.
    measure
    The rate of incontinence, erectile dysfunction, urinary symptoms
    time Frame
    Randomisation visit, Day 7 after VTP , Month 3, Month 6, Month 9, Month 12, Month 24
  4. description
    Number of patients experiencing adverse events divided by the total number of patients.
    measure
    The rate of adverse events
    time Frame
    Screening-Month 24
  5. description
    Number of patients experiencing severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death divided by the total number of patients.
    measure
    The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
    time Frame
    Screening-Month 24
  6. description
    Results of the International Index of Erectile Function (IIEF) and International Prostate Symptoms Score (IPSS) patients questionaires.
    measure
    The overall quality of life will be recorded for potential utility and descriptive studies.
    time Frame
    Randomisation visit; Month 12; Month 24
Full study description
brief Summary
The aims of this study are: * to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and * to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).
detailed Description
This is a Phase 3, multicentre, open label, randomised controlled study in subjects diagnosed with low risk prostate cancer on TransRectal Ultrasound (TRUS) guided biopsy. Subjects will be randomised to either Active Surveillance or TOOKAD® Soluble VTP. Subjects will remain in the study for approximately 24 months following randomisation. A total of 400 subjects will be entered into the study; 200 will receive Active Surveillance and 200 will receive TOOKAD® Soluble-VTP.
Source references
references
  1. citation
    Azzouzi AR, Vincendeau S, Barret E, Cicco A, Kleinclauss F, van der Poel HG, Stief CG, Rassweiler J, Salomon G, Solsona E, Alcaraz A, Tammela TT, Rosario DJ, Gomez-Veiga F, Ahlgren G, Benzaghou F, Gaillac B, Amzal B, Debruyne FM, Fromont G, Gratzke C, Emberton M; PCM301 Study Group. Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial. Lancet Oncol. 2017 Feb;18(2):181-191. doi: 10.1016/S1470-2045(16)30661-1. Epub 2016 Dec 20.
    pmid
    28007457
    type
    RESULT
  2. citation
    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
    type
    DERIVED
  3. citation
    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
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      source title
      Prostate Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice