E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Localized prostate cancer |
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E.1.1.1 | Medical condition in easily understood language |
Localized prostate cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 characterize and to quantify the histopathologhical changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (MRI) following a single injection of Liproca® Depot in patients with localized prostate cancer. |
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E.2.2 | Secondary objectives of the trial |
To evaluate efficacy and safety of a single injection of Liproca® Depot in patients with localized prostate cancer, and to follow the pharmacokinetic profile of Liproca® Depot. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Age ≥ 50 years, ≤ 75 years
2) Histologically confirmed localized (stage T1c, T2a-T2c) prostate cancer that is judged relevant for prostatectomy.
3) PSA value < 20 ng/ml within 6 weeks before enrolment.
4) Gleason score 3+4 at diagnostic biopsy (or preferably with more precise method for judging the localization of the primary tumour focus (foci).
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) Negative dipstick for bacteriuria.
8) Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.
9) Patients that has been scheduled for prostatectomy |
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E.4 | Principal exclusion criteria |
1) On-going hormone therapy for prostate cancer.
2) On-going or previous therapy within 12 month of finasteride or dutasteride. 3) On-going or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
4) Use of pace maker or other electronic devices 5) Symptoms or signs of acute prostatitis.
6) Symptoms or signs of ulceric proctitis
7) Severe micturation symptoms (I-PSS >17)
8) On-going therapy with anticoagulant (e.g Warfarin. Other anticoagulant should be withdrawn 1 week before injection).
9) Concomitant systemic treatment with corticosteroids, or immune modulating agents.
10) Known immunosuppressive disease (e.g. HIV, diabetes).
11) 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) |
• Characterize and quantify the histopathologhical changes in surgical specimens.
• Change in diffusion/flow of tissue water (apparent diffusion coefficient; ADC) before and after treatment assessed by diffusion-weighted imaging (MRI). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Four and six weeks after dosing |
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E.5.2 | Secondary end point(s) |
• Quantification of Choline+Creatine/Citrate ratio before and after treatment (MRSI).
• Change in surface fraction and volume of the treated tumour focus (foci) (based on MRI and histopathology of the surgical specimens).
• Change in plasma PSA before and after treatment.
• Change in total prostate volume before and after treatment.
• Tolerability of the treatment.
• Plasma pharmacokinetics of 2-HOF. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Four and six weeks after dosing |
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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 | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 | No |
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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The 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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |