A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for low risk localised prostate cancer compared to Active Surveillance

Phase 1

• Conditions: ow-risk prostate cancer; MedDRA version: 12.1Level: LLTClassification code 10060862Term: Prostate cancer

• Registration Number: EUCTR2010-021900-93-FR
• Lead Sponsor: STEBA BIOTECH SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-03
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 400

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

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cardiac or respiratory disease precluding general anaesthesia; anticoagulant treatment which cannot be temporarily withdrawn for the procedure);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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified