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| Name | Class |
|---|---|
| Uppsala University | OTHER |
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The primary aim of the study was to characterize and quantify the histopathological 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.
The primary aim of the study was to characterize and quantify the histopathological 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.
The secondary aims ere to evaluate efficacy and safety of a single injection of Liproca Depot, and to follow the pharmacokinetic profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liproca Depot | Experimental | A parenteral controlled release depot formulation of 2-hydroxyflutamide (2-HOF) is given as a single dose injection into the prostate gland within the lobe area where the tumour tissue is localized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-hydroxyflutamide (2-HOF) | Drug | Two components are mixed, transferred to a syringe and administered with injection into the prostate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterization and quantification of histopathological measurement of tumour tissue obtained from diagnostic biopsy. | Day 1 | |
| Characterization and quantification of histopathological measurement of tumour tissue in surgical specimens obtained from patients undergoing prostatectomy | Six weeks | |
| The diffusion/flow of tissue water (ADC) before and after treatment assessed by diffusion-weighted imaging (MRI) | Six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Choline, Creatinine and Citrate in tumour tissue before and after treatment | Six weeks | |
| Surface fraction and volume of treated tumour focus (foci) based on MRI and histopathological map from surgical specimens at baseline and end of study, respectively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Urology, University Hospital | Tampere | Finland | ||||
| Dept of Urology, University Hospital |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C014290 | hydroxyflutamide |
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| Six weeks |
| Concentration of Plasma Prostate Specific Antigen (PSA) | Six weeks |
| Total prostate volume by histopathology/MRI measúrements | Six weeks |
| Number of participants with Adverse Events as a measure of Safety and Tolerability | Six weeks |
| Number of abnormal, clinically relevant, parameters from laboratory analyses | Six weeks |
| Pharmacokinetics (Tmax and Cmax) of 2-hydroxyflutamide (2-HOF) | Six weeks |
| Uppsala |
| Uppsala County |
| 756 53 |
| Sweden |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |