E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Localized prostate cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 with both normal (<60cc) and high-volume prostates (≥60cc). |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the safety and quality of life following WST11 VTP treatment in patients with localized prostate cancer and both normal (<60cc)- and high-volume prostates (≥60cc).
- To assess the effects of a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer after a first VTP treatment in patients with both normal (<60cc) and high-volume prostates (≥60cc).
- 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 in patients with both normal (<60cc) and high-volume prostates (≥60cc).
- To explore optimisation techniques to reduce the duration of the VTP procedure |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 <LLN, PT >ULN, PT>ULN, aPTT >ULN, fibrinogen<LLN, D-Dimer >ULN 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.). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The result of the Month 6 12-core prostate biopsy will give the primary efficacy criterion of this study. The success of the treatment for a patient is defined by negative biopsy in the treated lobes that initially contained the tumor(s).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |