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

Purpose

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).

Condition	Intervention	Phase
Prostate Cancer	Drug: TOOKAD® Soluble	Phase 3

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Prostate Diseases

U.S. FDA Resources

Further study details as provided by Steba Biotech S.A.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	400
Study Start Date:	February 2011
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: TOOKAD® Soluble	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
No Intervention: Active Surveillance Active surveillance is one of the management strategy in men who have low-risk prostate cancer

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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 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.
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310894

Show 57 Study Locations

Sponsors and Collaborators

Steba Biotech S.A.

Investigators

Principal Investigator:

Mark Emberton, Professor

University College of London Hospital , United Kingdom

More Information

No publications provided

Responsible Party:	Steba Biotech S.A.
ClinicalTrials.gov Identifier:	NCT01310894 History of Changes
Other Study ID Numbers:	CLIN1001 PCM301
Study First Received:	March 1, 2011
Last Updated:	March 25, 2013
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Italy: The Italian Medicines Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency Switzerland: Swissmedic

Keywords provided by Steba Biotech S.A.:

Prostatic Disease
Genital Neoplasm,male
Urogenital neoplasm
Genital disease,male
Male urogenital disease

Neoplasms
Neoplasms by site
Prostatic neoplasm
Carcinoma

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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