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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 30

Inclusion Criteria

1.Men over 18 years of age;
2.Diagnosed with prostate cancer and eligible for active surveillance;
3.No prior treatment for prostate cancer;
4.Prostate Cancer Stage up to cT2b – N0/Nx – M0/Mx (rT2c and pT2c are acceptable);
5.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.
6.PSA < 10 ng/mL;
7.Signed Informed Consent Form.
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.Any condition or history of illness or surgery that, in the opinion of the investigator and/or the Sponsor, might confound the results of the study or pose additional risks to the patient.
2.All patients whose current pre-operative cardiac evaluation does not show their fitness for a procedure requiring general anesthesia;
3.Patients with a prior history of viral or alcoholic hepatitis, and other patients felt to be at risk for hepatotoxicity including concomitant use of potentially hepatotoxic medications or dietary supplements;
4.Patients with a history of inflammatory bowel disease or other factors which may increase the risk of fistula formation;
5.Men who have received any hormonal manipulation (excluding 5-alpha reductase inhibitors) or androgen supplements within the previous 6 months;
6.Men previously treated by radiation therapy (external therapy or brachytherapy) or chemotherapy or any therapy for prostate cancer;
7.Men who have received or are receiving chemotherapy for prostate carcinoma or other significant cancer;
8.Men who have undergone previous TURP (trans-urethral resection of the prostate);
9.Men who are currently receiving any medications having potential photosensitizing effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin).
10.Men who are receiving anticoagulant drugs (e.g.: coumadin, warfarin).
11..Patient who stopped long term treatment of acetylsalicylic acid (aspirin) or other anti platelets agents less than 15 days before the procedure;
12.Patient suspected of Disseminated Intravascular Coagulation (DIC) as defined by the presence of three out of the five following criteria: platelets ULN, PT>ULN, aPTT >ULN, fibrinogenULN
13.History of non compliance with medical therapy and medical recommendations or an unwillingness or inability to complete patient self-administered questionnaires;
14.Participation in a clinical study or receipt of an investigational treatment within the past 3 months;
15.A history of porphyria;
16.A history of sun hypersensitivity or photosensitive dermatitis;
17.Renal disorders (blood creatinine > 1.5 x ULN) or known post mictional residue > 150cc
18.Hepatic disorders (transaminases > ULN, bilirubin > ULN,). In case of slight abnormalities, another exam should be performed. If the results are within normal ranges, then the patient can be included;
19.Hematological disorders (white cells < 2500/mm3, neutrophils < 1500/mm3, platelets < 140.000/mm3, Hb < 8 g/dL);
20.Patient with contra-indication to MRI (such as pace maker, metal prosthesis, etc.).

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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