Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer ... | Completed
Efficacy and Safety Study of TOOKAD... | Completed
Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.
PCM301

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Medical Conditions
  • Prostate Cancer
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01310894

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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).
Research Details
  • 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.
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : TOOKAD® Soluble

Study Arm Groups : TOOKAD® Soluble

Intervention Type
See Interventions above
Primary Outcome Measures
    Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.; Month 24; 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.; Over 24 months follow-up.
Secondary Outcome Measures
    The rate of additional prostate cancer radical therapy; Over 24 months follow-up; Total number of cores positive for cancer; Month 24; The rate of incontinence, erectile dysfunction, urinary symptoms; Randomisation visit, Day 7 after VTP , Month 3, Month 6, Month 9, Month 12, Month 24; The rate of adverse events; Screening-Month 24; The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death; Screening-Month 24; The overall quality of life will be recorded for potential utility and descriptive studies.; Randomisation visit; Month 12; Month 24
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Male
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
London
Greater London
King's College Hospital
London
SE5 9RS
Sheffield
Oxford
OX3 7LJ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Belgium, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CLIN1001 PCM301
Sponsor(s)
Steba Biotech S.A.
Key Dates

Recruitment Start Date

Feb 2011

Recruitment End Date

Jun 2015

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

01 Mar 2011

Date updated in source

17 Apr 2016