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

Recruiting

• Source

  -

  Public Title	Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.
  Acronym	PCM301
  Source of Record URL	http://clinicaltrials.gov/show/NCT01310894

• Trial

  -

  Health Condition(s) or Problem	Prostate Cancer
  Lay 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). (from ClinicalTrials.gov)
  Who can enter the trial	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)
  Who cannot enter the trial	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)
  What will happen	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
  Primary aim	Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.; 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.
  Secondary Aim	The rate of additional prostate cancer radical therapy; Over 24 months follow-up; No; Total number of cores positive for cancer; Month 24; No; The rate of incontinence, erectile dysfunction, urinary symptoms; Randomisation visit, Day 7 after VTP , Month 3, Month 6, Month 9, Month 12, Month 24; Yes; The rate of adverse events; Screening-Month 24; Yes; The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death; Screening-Month 24; Yes; The overall quality of life will be recorded for potential utility and descriptive studies.; Randomisation visit; Month 12; Month 24; Yes
  Participant Information Sheet	Sorry, not currently available
  Website	Sorry, not currently available
  Recruitment Status	Recruiting
  Nation	England
  Location	London, Oxford, Sheffield

• Contact

  -

  Contact for Public Queries

  Mark Emberton, Professor Principal Investigator University College of London Hospital , United Kingdom

  Contact for Scientific Queries

  Steven Joniau, Professor; Principal Investigator; Teuvo Tammela, Professor; Principal Investigator; Abdel Rahmene Azzouzi, Professor; Principal Investigator; François Kleinclauss, Professor; Principal Investigator; Antony Cicco, Doctor; Principal Investigator; Pierre Coeurdacier, Doctor; Principal Investigator; Jean Luc Descotes, Pr; Principal Investigator; Arnauld Villers, Professor; Principal Investigator; Gilles Karsenty, Professor; Principal Investigator; Thierry Guetta, Dr; Principal Investigator; Hervé Quintens, Dr; Principal Investigator; Marc Galiano, Doctor; Principal Investigator; Olivier Cussenot, Professor; Principal Investigator; Marc Zerbib, Professor; Principal Investigator; Eric Barret, Dr; Sub-Investigator; Alain Ruffion, Professor; Principal Investigator; Frédéric Staerman, Professor; Principal Investigator; Sébastien Vincendeau, Doctor; Principal Investigator; Eric Potiron, Doctor; Principal Investigator; Henry Botto, Professor; Principal Investigator; Bernard Malavaud, Professor; Principal Investigator; Axel Heidenreich, Pr; Principal Investigator; Stefan Machtens, Dr; Principal Investigator; Frank Konig, Dr; Principal Investigator; Lukas Manka, Dr; Principal Investigator; Manfred Wirth, Professor; Principal Investigator; Stefan Carl, Doctor; Principal Investigator; Georg Salomon, Professor; Principal Investigator; Georg Salomon, Pr; Principal Investigator; Martin Burmester, Dr; Principal Investigator; Jens Rassweiler, Professor; Principal Investigator; Klaus-Peter Jünemann, Professor; Principal Investigator; Christian Stief, Professor; Principal Investigator; Joachim Doersman, Doctor; Principal Investigator; Novello Pinzi, Pr; Principal Investigator; Filiberto Zattoni, Pr; Principal Investigator; Andrea Tubaro, Professor; Principal Investigator; Claudio Giberti, Pr; Principal Investigator; Paolo Gontero, Pr; Principal Investigator; Hank Van Der Poel, Professor; Principal Investigator; Michel De Wildt, Professor; Principal Investigator; José Francisco Suarez Novo, Dr; Principal Investigator; Francisco Gomez Veiga, Pr; Principal Investigator; Juan Palou, Dr; Principal Investigator; Antonio Alcaraz, Doctor; Principal Investigator; Juan Morote Roble, Dr; Principal Investigator; Alfredo Rodriguez Antolin, Dr; Principal Investigator; Rafael Antonio Medina Lopez, Dr; Principal Investigator; Eduardo Solsona, Professor; Principal Investigator; Goran Ahlgren, Professor; Principal Investigator; Peter Wiklund, Pr; Principal Investigator; George Thalmann, Professor; Principal Investigator; Alain Bitton, Dr; Principal Investigator; Mark Emberton, Professor; Principal Investigator; Gordon Muir, Professor; Principal Investigator; Freddie Hamdy, Professor; Principal Investigator; D.J. Rosario, Professor; Principal Investigator