E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
prostate cancer (T1-T2), Gleason ≤ 3+4 at the time of diagnose in prostate biopsy |
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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 | 10007113 |
E.1.2 | Term | Cancer of prostate |
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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 |
Part I To evaluate efficacy of a single dose of Liproca® Depot in patients with localized prostate cancer.
Part II To evaluate efficacy after a second injection in patients progressing 3-6 months after first injection (extension of study)
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E.2.2 | Secondary objectives of the trial |
To evaluate safety and Quality of Life of a single and multiple injections of Liproca® Depot in patients with localized prostate cancer, and to follow the pharmacokinetic and pharmacodynamic profile of Liproca® Depot.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Signed Informed Consent must be obtained before any study specific procedures takes place. 1. Age ≥ 45 years 2. Histologically confirmed localized prostate cancer (T1–T2) predominantly in one side of the periferal zone, verified by biopsy. 3. PSA value < 20 ng/ml within 6 weeks before enrolment. 4. Gleason score ≤ 3+4 at diagnostic biopsy 5. Adequate renal function: Creatinine < 1.5 times upper limit of normal. 6. Adequate hepatic function: ASAT, ALAT and ALP < 1.5 times upper limit of normal. 7. No bacturia (test by dipstick). 8. Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.
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E.4 | Principal exclusion criteria |
1. Previous or ongoing hormone therapy for prostate cancer. 2. Ongoing or previous therapy (within 3 month) of finasteride or dutasteride. 3. Ongoing or previous invasive therapy for benign prostata hyperplasia (TURP, TUMT). 4. Symptoms or signs of acute prostatitis or other local inflammation. 5. Symptoms or signs of ulceric proctitis 6. Severe micturation symptoms (I-PSS > 17) 7. Concomitant systemic treatment with corticosteroids, or immunomodulating agents. 8. Known immunosuppressive disease (e.g. HIV, diabetes). 9. Simultaneous participation in any other study involving not market authorized drugs or having participated in a study within the last 12 months prior to start of study treatment.
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E.5 End points |
E.5.1 | Primary end point(s) |
PSA nadir (Concentration of PSA in serum) |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 0 |
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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last visit of the last subject |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |