A Study of 2-hydroxyflutamide (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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 secondary aims ere to evaluate efficacy and safety of a single injection of Liproca Depot, and to follow the pharmacokinetic profile.

Official Title
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An Open, Single Dose, Antitumour Effect Study of 2-hydroxy-flutamide as a Controlled Release Product (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 2-hydroxyflutamide (2-HOF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 50 years, ≤ 75 years Histologically confirmed localized (stage T1c, T2a-T2c) prostate cancer that is judged relevant for prostatectomy. PSA value < 20 ng/ml within 6 weeks before enrolment. Gleason score ≤ 3+4 at diagnostic biopsy (or preferably with more precise method for judging the localization of the primary tumour focus (foci). Adequate renal function: Creatinine < 1.5 times upper limit of normal. Adequate hepatic function: Aspartate Transaminase (ASAT), Alanine Transaminase (ALAT) and Alkalase Phosphatase (ALP) < 1.5 times upper limit of normal. Negative dipstick for bacteriuria. Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit. Patients that has been scheduled for prostatectomy Exclusion Criteria: Ongoing or previous hormone therapy for prostate cancer. On-going or previous therapy within 12 month of finasteride or dutasteride. On-going or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT). Use of pace maker or other electronic devices Symptoms or signs of acute prostatitis. Symptoms or signs of ulcered proctitis Severe micturation symptoms On-going therapy with anticoagulant (e.g Warfarin. Other anticoagulant should be withdrawn 1 week before injection). Concomitant systemic treatment with corticosteroids, or immune modulating agents. Known immunosuppressive disease (e.g. HIV, diabetes). 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liproca Depot<br>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. | Drug: 2-hydroxyflutamide (2-HOF)<br>* Two components are mixed, transferred to a syringe and administered with injection into the prostate<br>* Other names: Liproca Depot;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |