NCT02341404

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started May 2012

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 11, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

October 17, 2014

Last Update Submit

March 10, 2016

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

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

    Day 1

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

    Six weeks

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

    Six weeks

Secondary Outcomes (7)

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

    Six weeks

  • 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

    Six weeks

  • Concentration of Plasma Prostate Specific Antigen (PSA)

    Six weeks

  • Total prostate volume by histopathology/MRI measúrements

    Six weeks

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

    Six weeks

  • +2 more secondary outcomes

Study Arms (1)

Liproca Depot

EXPERIMENTAL

A parenteral controlled release depot formulation of 2-hydroxyflutamide (2-HOF) is given as a single dose injection into the prostate gland within the lobe area where the tumour tissue is localized.

Drug: 2-hydroxyflutamide (2-HOF)

Interventions

2-hydroxyflutamide (2-HOF)DRUG

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

Also known as: Liproca Depot
Liproca Depot

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept of Urology, University Hospital

Tampere, Finland

Location

Dept of Urology, University Hospital

Uppsala, Uppsala County, 756 53, Sweden

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

hydroxyflutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2014

First Posted

January 19, 2015

Study Start

May 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 11, 2016

Record last verified: 2016-03

Locations

SE(1)FI(1)