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Completed

NCT Number: NCT01310894

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

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).

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Key information

Conditions

Prostate Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Dept. of Urology-University Hospitals Leuven, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects will be eligible for inclusion in the study if all of the following criteria are met:

  • 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.
  • Cancer clinical stage up to T2a (pathological or radiological up to T2c disease permitted)
  • Serum prostate specific antigen (PSA) of 10 ng/mL or less
  • Prostate volume equal or greater than 25 cc and less than 70 cc.
  • Male subjects aged 18 years or older.

Exclusion criteria

Subjects will not be eligible for the study if meeting any of the following criteria:

  • Unwillingness to accept randomisation to either of the two arms of the study
  • Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy.
  • Any surgical intervention for benign prostatic hypertrophy
  • Life expectancy less than 10 years.
  • Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
  • Participation in another clinical study or recipient of an investigational product within 1 month of study entry.
  • Subject unable to understand the patient's information document, to give consent or complete the study tasks.
  • Subject in custody and or in residence in a nursing home or rehabilitation facility
  • 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)
  • Any condition or history of illness or surgery that may pose an additional risk to men undergoing the TOOKAD® Soluble VTP procedure.

Treatment and study plan

TOOKAD® Soluble

Drug

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

Other names: WST11

Primary outcomes

  1. Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.

    Time frame: Month 24

    Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.

  2. 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.

    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

Secondary outcomes

  1. The rate of additional prostate cancer radical therapy

    Time frame: Over 24 months follow-up

    Number of patients undergoing a radical treatment for prostate cancer such as: radical prostatectomy, radiotherapy, brachytherapy divided by the total number of patients.

  2. Total number of cores positive for cancer

    Time frame: Month 24

    Total number of biopsy sample containing tumor cells at the month 24 biopsy

  3. 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

    Number of patients experiencing urinary incontinence, erectile dysfunction or urinary symptoms events divided by the total number of patients.

  4. The rate of adverse events

    Time frame: Screening-Month 24

    Number of patients experiencing adverse events divided by the total number of patients.

  5. The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death

    Time frame: Screening-Month 24

    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.

  6. The overall quality of life will be recorded for potential utility and descriptive studies.

    Time frame: Randomisation visit; Month 12; Month 24

    Results of the International Index of Erectile Function (IIEF) and International Prostate Symptoms Score (IPSS) patients questionaires.

Sponsors and collaborators

Lead sponsor

Steba Biotech S.A.

Other

Registry information

Official study title

A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance

Acronym: PCM301

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 9, 2011
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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