An open, single and multiple dose, efficacy and safety Proof of Principle study of Liproca® Depot, a controlled release formulation of 2-hydroxyflutamide, injected into the prostate in patients with localized prostate cancer - Liproca® Depot

• Conditions: prostate cancer (T1-T2), Gleason = 3+4 at the time of diagnose in prostate biopsy; MedDRA version: 9.1Level: LLTClassification code 10007113Term: Cancer of prostate

• Registration Number: EUCTR2009-010079-25-FI
• Lead Sponsor: IDDS AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 0

Inclusion Criteria

Signed Informed Consent must be obtained before any study specific procedures takes place.
1.Age = 45 years
2.Histologically confirmed localized prostate cancer (T1–T2) predominantly in one side of the periferal zone, verified by biopsy.
3.PSA value < 20 ng/ml within 6 weeks before enrolment.
4.Gleason score = 3+4 at diagnostic biopsy
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.No bacturia (test by dipstick).
8.Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.

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

Exclusion Criteria

1.Previous or ongoing hormone therapy for prostate cancer.
2.Ongoing or previous therapy (within 3 month) of finasteride or dutasteride.
3.Ongoing or previous invasive therapy for benign prostata hyperplasia (TURP, TUMT).
4.Symptoms or signs of acute prostatitis or other local inflammation.
5.Symptoms or signs of ulceric proctitis
6.Severe micturation symptoms (I-PSS > 17)
7.Concomitant systemic treatment with corticosteroids, or immunomodulating agents.
8.Known immunosuppressive disease (e.g. HIV, diabetes).
9.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: Part I<br>To evaluate efficacy of a single dose of Liproca® Depot in patients with localized prostate cancer.<br><br>Part II <br>To evaluate efficacy after a second injection in patients progressing 3-6 months after first injection (extension of study)<br><br> <br>;Secondary Objective: To evaluate safety and Quality of Life of a single and multiple injections of Liproca® Depot in patients with localized prostate cancer, and to follow the pharmacokinetic and pharmacodynamic profile of Liproca® Depot.<br><br>;Primary end point(s): PSA nadir (Concentration of PSA in serum)