The Treatment of prostate cancer. MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Product Name: WST11 padeliporfin dipotassium
Product Code: WST11
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Padeliporfin
CAS Number: RN886845723
Current Sponsor code: WST11
Concent
Sponsors
STEBA BIOTECH NV
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the optimal treatment conditions to achieve prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in patients with localized prostate cancer. ;Secondary Objective: •To evaluate the safety and quality of life following WST11 VTP treatment in patients with localized prostate cancer. . •To assess the effects of a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer after a first VTP treatment. •To evaluate the safety and quality of life following a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer after a first VTP treatment. •To assess the pharmacokinetic parameters and to model the relationship between concentration and effects. ;Primary end point(s): The result of the Month 3 12-core prostate biopsy will give the primary efficacy criterion of this study. Primary criterion: success of the treatment for a patient is defined by negative biopsy in the treated lobes that initially contained the tumor(s). | — |
Countries
France, Netherlands, United Kingdom
Outcome results
None listed