Skip to main content
OpenTrials
Completed

NCT Number: NCT00913263

An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate

The primary objective was to evaluate efficacy of a single dose of Liproca Depot in patients with localized prostate cancer. Primary efficacy variable was the proportion of patients showing PSA nadir. 24 Caucasian men, with a mean age at inclusion of 68.4 years, with localized prostate cancer were injected once with a ready made paste including 600 mg 2-hydroxyflutamide (Liproca Depot) into the site of the prostate where the tumour was localized. The patient was monitored for prostate-specific antigen (PSA) for maximum 6 months or to progression within this time period. The primary endpoint showed interesting results with high success rate (83%), i.e. proportion of patients (Responders) that reached plasma PSA nadir.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tampere University Hospital, Tampere, Finland

Loading trial locations.

About this study

Patients with localized prostate cancer were followed to progression or maximum 24 weeks after a single injection in one lobe of 2-8 mL ready-made paste (corresponding to 400-1600 mg 2-Hydroxyflutamid). Progression was defined as an increase in PSA by > 25% over baseline or on-treatment nadir.Among the 24 patients the primary endpoint, plasma PSA nadir, was reached by 20 patients (Responders). Efficacy was measured primarily as PSA nadir, and secondly as time to PSA nadir and prostate volume change. Safety was monitored throughout the whole study period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 45years
  • Histologically confirmed localized prostate cancer (T1-T2), predominantly in one side of the peripheral zone, verified by biopsy.
  • PSA value < 20 ng/ml within 6 weeks before enrolment.
  • Gleason score ≤ 3+4 at diagnostic biopsy
  • Adequate renal function: Creatinine < 1.5 times upper limit of normal.
  • Adequate hepatic function: ASAT, ALAT and ALP < 1.5 times upper limit of normal.
  • Negative dipstick for bacturia.
  • Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.

Exclusion criteria

  • Previous or ongoing hormone therapy for prostate cancer.
  • Ongoing or previous therapy (within3 month) of finasteride or dutasteride.
  • Ongoing or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
  • Symptoms or signs of acute prostatitis.
  • Symptoms or signs of ulceric proctitis
  • Severe micturation symptoms (I-PSS >17)
  • Concomitant systemic treatment with corticosteroids, or immunomodulating agents.
  • Known immunosuppressive disease (e.g. HIV, insulin dependent diabetes).
  • 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.

Treatment and study plan

2-hydroxyflutamide (2-HOF) [Liproca Depot]

Drug

Ready made paste including 600 mg 2-HOF for injection as a single dose

Other names: Liproca Depot

2-Hydroxyflutamide

Drug

The Product consists of two sterile components, one aqueous liquid and a dry powder, containing the active drug 2-Hydroxyflutamide (2-HOF. The two components were mixed under aceptic conditions to a paste prior to administration.

Other names: Liproca Depot

Primary outcomes

  1. Proportion of Patients Showing PSA Nadir

    Time frame: Measured every 4th week until progression or maximum 6 months.

    Plasma PSA nadir is the lowest PSA reading achieved after any treatment for prostate cancer. The patients were observed once every 4th week during the study period.

Secondary outcomes

  1. Number of Patients Reporting Adverse Events Caused by the Study Treatment

    Time frame: Measured every 4th week till progression or maximum 6 months

    • Adverse events caused by the study treatment
    • Abnormal, clinically relevant, laboratory parameters
    • Voiding symptoms
    • Vital Signs
    • Quality of Life

  2. Percent Change in Prostate Volume From Baseline to Nadir.

    Time frame: Measured every 4th week until progression or maximum 6 months.

    Prostate volume was measured at each visit to capture nadir and compared to baseline for all patients. Decrease in prostate volume is reported as percent change from baseline.

  3. Time to PSA Nadir

    Time frame: Measured every 4th week until progression or maximum 6 moths.

    Time frame was from baseline to day of PSA nadir.

  4. Percent Change in Prostate Volume From Baseline to Final Visit

    Time frame: Measured every 4th week until progresion or maximum 6 months.

    Prostate volume was captured at each visit and percent change from baseline to final visit was measured. Final visit was either day of progression or after 6 months. Prostate volume decrease is reported in percent change from baseline

  5. Number of Days to Prostate Volume Nadir.

    Time frame: Measured every 4th week until progression or maximum 6 months.

    Number of Days from day of injection to prostate volume nadir.

Sponsors and collaborators

Lead sponsor

Lidds AB

Industry

Registry information

Official study title

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

Acronym: 2-HOF

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 4, 2009
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.