FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-010079-25-FI
Enrollment
Unknown
Registered
2009-03-12
Start date
2009-05-11
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: Liproca® Depot Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: 2-hydroxyflutamide CAS Number: 52806-53-8 Concentration unit: mg milligram(s) Con

Sponsors

LIDDS AB
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: Part I To evaluate efficacy of a single dose of Liproca® Depot in patients with localized prostate cancer. Part II To evaluate efficacy after a second injection in patients progressing 3-6 months after first injection (extension of study) ;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. ;Primary end point(s): PSA nadir (Concentration of PSA in serum)—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026