Phase 2
Completed N=30
Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer
Source: ClinicalTrials.gov NCT00946881 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Prostate Biopsy — 0; 3; 8; 11 participants
Summary
The aim of this study is to determine the optimal treatment conditions (WST11 dose and light energy dose) to achieve ablation in one lobe of the prostate and to evaluate the safety and quality of life of WST11 medicated Vascular-Targeted Photodynamic therapy (VTP) in men with localized prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prostate Biopsy |
0; 3; 8; 11; 3; 3 | — |
| PRIMARY Prostate Biopsies |
3; 3; 13; 19 | — |
| SECONDARY Pharmacokinetic Parameters-Cmax |
30883.83; 57102.87 | — |
| SECONDARY Percentage of Prostatic Necrosis at Day 7 as Observed on the 7-Day MRI |
46.9; 13.8; 61.1; 52.3 | — |
| SECONDARY International Index of Erectile Functions (IIEF) Results |
21.33; 13.17; 18.80; 17.90; 14.33; 14.00 | — |
| SECONDARY International Prostate Symptom Score (IPSS) Results |
10.67; 11.67; 8.65; 9.48; 9.67; 11.00 | — |
| SECONDARY Pharmacokinetic Parameters-Tmax |
0.43; 0.25 | — |
| SECONDARY Pharmacokinetic Parameters -T1/2 |
1.25; 1.69 | — |
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Diagnosed with localized, prostate cancer and who have been offered curative therapy (radical prostatectomy; cryotherapy; brachytherapy; External Beam RadioTherapy (EBRT), and refused
- Localized prostate cancer stage T1C up to T2A based on biopsy performed at least 6 weeks prior to enrollment
- Gleason score ≤ 3+3 with ≤50% of sampled cores positive, and each positive core having a tumour length of ≤5 mm
- Prostate Specific Antigen (PSA) 1.5 x ULN) or known post mictional residue > 150cc
- 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;
- Hematological disorders (white cells < 2500/mm3, neutrophils < 1500/mm3, platelets, < 140.000/mm3, Hb ≤ 10 g/dL);
- Patients with contra-indication to MRI (such as pace maker, metal prosthesis, etc.).
Data sourced from ClinicalTrials.gov (NCT00946881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.