Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. | Not Recruiting
Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.
PCM301
Trial Source

Health Conditions
  • Prostate Cancer
Not Recruiting
Recruitment Status
NCT01310894
Primary Trial ID Number
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).
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
Research Question
  • 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).
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
Belgium; Finland; France; Germany; Italy; Netherlands; Spain; Sweden; Switzerland; United Kingdom
Participant Sex
Male
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
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 within 12 months of 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. Subject in custody and or in residence in a nursing home or
  • rehabilitation facility
  • 8. 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)
Participant Exclusion 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 within 12 months of 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. Subject in custody and or in residence in a nursing home or
  • rehabilitation facility
  • 8. 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)
Interventions
Drug; TOOKAD® Soluble; TOOKAD® Soluble-VTP procedure will consist of an IntraVenous (IV) administration of 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; [TOOKAD® Soluble]
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
PCM301
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
Secondary Trial Identifying Number
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Website
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Study Funded By
Steba Biotech S.A.
Funder Type
Sorry, this information is not available
Study Sponsored By
Steba Biotech S.A.
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

01 Mar 2011

Last Updated

27 Apr 2015

Date Record Refreshed on UKCTG

31 Jul 2015