A study of the effect of Liproca® Depot on prostate cancer

Conditions: ocalized prostate cancer
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-001137-16-FI

Lead Sponsor: IDDS AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 18

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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

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 Other anticoagulant should be withdrawn 1 week before injection).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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br> • 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 and six weeks after dosing

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Quantification of Choline+Creatine/Citrate ratio before and after treatment (MRSI). <br>• Change in surface fraction and volume of the treated tumour focus (foci) (based on MRI and histopathology of the surgical specimens). <br>• Change in plasma PSA before and after treatment. <br>• Change in total prostate volume before and after treatment. <br>• Tolerability of the treatment. <br>• Plasma pharmacokinetics of 2-HOF.;Timepoint(s) of evaluation of this end point: Four and six weeks after dosing