Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. (PCM301)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance|
- Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison. [ Time Frame: Month 24 ] [ Designated as safety issue: No ]Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.
- 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. ] [ Designated as safety issue: No ]
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
- The rate of additional prostate cancer radical therapy [ Time Frame: Over 24 months follow-up ] [ Designated as safety issue: No ]
- Total number of cores positive for cancer [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- The rate of adverse events [ Time Frame: Screening-Month 24 ] [ Designated as safety issue: Yes ]
- The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death [ Time Frame: Screening-Month 24 ] [ Designated as safety issue: Yes ]
- The overall quality of life will be recorded for potential utility and descriptive studies. [ Time Frame: Randomisation visit; Month 12; Month 24 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: TOOKAD® Soluble
TOOKAD® Soluble, lyophilized formulation, given at a dose of 4mg/Kg.
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
Other Name: WST11
No Intervention: Active Surveillance
Active surveillance is one of the management strategy in men who have low-risk prostate cancer
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.
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|Principal Investigator:||Mark Emberton, Professor||University College of London Hospital , United Kingdom|