Localized prostate cancer
Conditions
Interventions
Product Name: Liproca® Depot
Product Code: Not applicable
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: 2-hydroxyflutamide
CAS Number: 52806-53-8
Current Sp
Sponsors
LIDDS AB
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: 1) On-going or previous 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, other electronic devices or metallic hip prosthesis device 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 Other anticoagulant should be withdrawn 1 week before injection). 9) Concomitant systemic treatment with corticosteroids, or immune modulating agents. 10) Known immunosuppressive disease (e.g. HIV,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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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.;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). ;Timepoint(s) of evaluation of this end point: Four, six and eight weeks after dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Four, six and eight weeks after dosing;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. • Change in urine flow • Tolerability of the treatment. • Plasma pharmacokinetics of 2-HOF. | — |
Countries
Finland, Sweden
Contacts
Public ContactLIDDS AB
LIDDS AB
Outcome results
None listed