Low-risk prostate cancer MedDRA version: 12.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Product Name: TOOKAD® Soluble
Product Code: WST11
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Padeliporfin
CAS Number: 886845-72-3
Current Sponsor code: WST11
Other des
Sponsors
STEBA BIOTECH SA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Low risk prostate cancer diagnosed using transrectal ultrasound guided biopsy using a minimum of 10 cores or equivalent, showing: • Clinical stage up to T2a (pathological or radiological up to T2c disease permitted), • Gleason 3 + 3 prostate adenocarcinoma, • A maximum of three (3) cores positive for cancer, • A maximum cancer core length of 5 mm in any core. 2) Serum prostate specific antigen (PSA) of 10 ng/mL or less. 3) Prostate volume more than 30 cc and less than 60 cc. 4) Male subjects aged 18 years or older. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion 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) Life expectancy less than 5 years. 4) Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure such as: 4.1) Any condition or history of illness or surgery that in the opinion of the Investigator might affect the conduct and results of the study or pose additional risks to the subject (e.g., active inflammatory bowel disease which may predispose to rectal fistula formation, cardiac or respiratory disease precluding general anaesthesia; anticoagulant treatment which cannot be temporarily withdrawn for the procedure); 4.2) Medical conditions which preclude the use of general anaesthesia. 4.3) A history of active rectal inflammatory bowel disease or other factors which may increase the risk of fistula formation. 4.4) Hormonal manipulation (excluding 5 alpha reductase inhibitors) or androgen supplements within the previous 6 months. 4.5) History of urethral stricture disease. 4.6) History of acute urinary retention within 6 months of study entry. 4.7) Men who have an absolute need for the following medication which have potential photosensitising effects (tetracyclines, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics and griseofulvin). 4.8) Men who have an absolute need for anticoagulant drugs or antiplatelet drugs (e.g., warfarin, aspirin) which cannot be withdrawn during the 10 days prior to the VTP procedure. 4.9) Renal and hepatic disorders with values of >1.5 times the upper limit of normal (ULN) and blood disorders (clinician judgement). 4.10) A history of sun hypersensitivity or photosensitive dermatitis. 5) Participation in another clinical study or recipient of an investigational product within 1 month of study entry. 6) Contra-indication to MRI (e.g., pacemaker), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To assess the impact of TOOKAD® Soluble VTP on the rate of absence of significant cancer (key secondary objective). To determine the differences between men who undergo TOOKAD® Soluble VTP and men on active surveillance with regard to: - the rate of additional prostate cancer therapy - the overall cancer burden in the prostate - Prostate Specific Antigen - the rate of adverse events - incontinence, erectile dysfunction, urinary and rectal discomfort - the overall quality of life and prostate-related anxiety;Primary end point(s): Failure of treatment due to progression of cancer from low to moderate or higher risk over the 24 month follow-up. Moderate or higher risk is defined as the observation of: - More than 3 cores positive for cancer when considering all biopsies 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 metastasis. Positive cores are considered whenever the length of cancer in the core is >1 mm in size. Histological changes are assessed using biopsies taken under the guidance of transrectal ultrasound at 12 and 24 months or at anytime time during follow-up. A panel blinded to the exposure status reviews the histological reports of all patients, whether reported positive or negative for cancer, and all the PSA data. | — |
Countries
Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed