VASCULAR-TARGETED PHOTODYNAMIC THERAPY USING WST11 IN PATIENTS WITH LOCALISED PROSTATE CANCE

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 24

Inclusion Criteria

1.Diagnosed with prostate cancer and eligible for active surveillance;
2.No prior treatment for prostate cancer;
3.Prostate Cancer Stage up to cT2b – N0/Nx – M0/Mx (rT2c and pT2c are acceptable);
4.Gleason score = 3+3 For patients characterized with prostate mapping (transperineal template guided biopsy at 5mm intervals) a secondary pattern 4 is acceptable provided that it is not present in more than 3 cores from each side of the prostate and is no more than 3 mm cancer core length.
5.PSA < 10 ng/mL;

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.All patients whose current pre-operative cardiac evaluation does not show their fitness for a procedure requiring general anesthesia;
2.Patients with a history of inflammatory bowel disease or other factors which may increase the risk of fistula formation;
3.Men who have received any hormonal manipulation (excluding 5-alpha reductase inhibitors) or androgen supplements within the previous 6 months;
4.Men previously treated by radiation therapy (external therapy or brachytherapy) or chemotherapy or any therapy for prostate cancer;
5.Men who have received or are receiving chemotherapy for prostate carcinoma or other significant cancer;
6.Men who have undergone previous TURP (trans-urethral resection of the prostate);
7.Men who are currently (within the month before the treatment procedure) receiving any medications having potential photosensitizing effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin);
8.Men who are currently receiving anticoagulant drugs (e.g.: coumadin, warfarin)
9.Patient who stopped long term treatment of acetylsalicylic acid (aspirin) or other anti platelets agents less than 15 days before the procedure;
10.Patient suspected of Disseminated Intravascular Coagulation (DIC) as defined by the presence of three out of the five following criteria: platelets decrease, increase of PT, increase of aPTT, fibrinogen decrease, D-Dimer increase.
11.A history of sun hypersensitivity or photosensitive dermatitis;
12.Renal disorders (blood creatinine > 1.5 x ULN) or known post mictional residue > 150cc
13.Hepatic disorders (transaminases > ULN, bilirubin > ULN, GGT > ULN). In case of slight abnormalities, another exam could be performed. If the results are within normal ranges, then the patient can be included;
14.Hematological disorders (white cells < 2500/mm3, neutrophils < 1500/mm3, platelets < 140.000/mm3, Hb < 8 g/dl);

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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