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NCT Number: NCT02341404

A Study of 2-hydroxyflutamide (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer

The primary aim of the study was to characterize and quantify the histopathological 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.

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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

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Dept of Urology, University Hospital, Tampere, Finland

Loading trial locations.

About this study

The primary aim of the study was to characterize and quantify the histopathological 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.

The secondary aims ere to evaluate efficacy and safety of a single injection of Liproca Depot, and to follow the pharmacokinetic profile.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 50 years, ≤ 75 years
  • Histologically confirmed localized (stage T1c, T2a-T2c) prostate cancer that is judged relevant for prostatectomy.
  • PSA value < 20 ng/ml within 6 weeks before enrolment.
  • Gleason score ≤ 3+4 at diagnostic biopsy (or preferably with more precise method for judging the localization of the primary tumour focus (foci).
  • Adequate renal function: Creatinine < 1.5 times upper limit of normal.
  • Adequate hepatic function: Aspartate Transaminase (ASAT), Alanine Transaminase (ALAT) and Alkalase Phosphatase (ALP) < 1.5 times upper limit of normal.
  • Negative dipstick for bacteriuria.
  • Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.
  • Patients that has been scheduled for prostatectomy

Exclusion criteria

  • Ongoing or previous hormone therapy for prostate cancer.
  • On-going or previous therapy within 12 month of finasteride or dutasteride.
  • On-going or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
  • Use of pace maker or other electronic devices
  • Symptoms or signs of acute prostatitis.
  • Symptoms or signs of ulcered proctitis
  • Severe micturation symptoms
  • On-going therapy with anticoagulant (e.g Warfarin. Other anticoagulant should be withdrawn 1 week before injection).
  • Concomitant systemic treatment with corticosteroids, or immune modulating agents.
  • Known immunosuppressive disease (e.g. HIV, 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)

Drug

Two components are mixed, transferred to a syringe and administered with injection into the prostate

Other names: Liproca Depot

Primary outcomes

  1. Characterization and quantification of histopathological measurement of tumour tissue obtained from diagnostic biopsy.

    Time frame: Day 1

  2. Characterization and quantification of histopathological measurement of tumour tissue in surgical specimens obtained from patients undergoing prostatectomy

    Time frame: Six weeks

  3. The diffusion/flow of tissue water (ADC) before and after treatment assessed by diffusion-weighted imaging (MRI)

    Time frame: Six weeks

Secondary outcomes

  1. Concentration of Choline, Creatinine and Citrate in tumour tissue before and after treatment

    Time frame: Six weeks

  2. Surface fraction and volume of treated tumour focus (foci) based on MRI and histopathological map from surgical specimens at baseline and end of study, respectively

    Time frame: Six weeks

  3. Concentration of Plasma Prostate Specific Antigen (PSA)

    Time frame: Six weeks

  4. Total prostate volume by histopathology/MRI measúrements

    Time frame: Six weeks

  5. Number of participants with Adverse Events as a measure of Safety and Tolerability

    Time frame: Six weeks

  6. Number of abnormal, clinically relevant, parameters from laboratory analyses

    Time frame: Six weeks

  7. Pharmacokinetics (Tmax and Cmax) of 2-hydroxyflutamide (2-HOF)

    Time frame: Six weeks

Sponsors and collaborators

Lead sponsor

Lidds AB

Industry

Collaborators

  • Uppsala University

Registry information

Official study title

An Open, Single Dose, Antitumour Effect Study of 2-hydroxy-flutamide as a Controlled Release Product (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 19, 2015
Registry last updated
Mar 11, 2016

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.

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