A Study of 2-hydroxyflutamide (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer
NCT ID: NCT02341404
Last Updated: 2016-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2012-05-31
2015-05-31
Brief Summary
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Detailed Description
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The secondary aims ere to evaluate efficacy and safety of a single injection of Liproca Depot, and to follow the pharmacokinetic profile.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Liproca Depot
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.
2-hydroxyflutamide (2-HOF)
Two components are mixed, transferred to a syringe and administered with injection into the prostate
Interventions
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2-hydroxyflutamide (2-HOF)
Two components are mixed, transferred to a syringe and administered with injection into the prostate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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: Aspartate Transaminase (ASAT), Alanine Transaminase (ALAT) and Alkalase Phosphatase (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
Exclusion Criteria
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 ulcered proctitis
7. Severe micturation symptoms
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.
50 Years
75 Years
MALE
No
Sponsors
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Uppsala University
OTHER
Lidds AB
INDUSTRY
Responsible Party
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Locations
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Dept of Urology, University Hospital
Tampere, , Finland
Dept of Urology, University Hospital
Uppsala, Uppsala County, Sweden
Countries
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Other Identifiers
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LPC-003
Identifier Type: -
Identifier Source: org_study_id
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