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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
2-hydroxyflutamide (2-HOF)
Sponsored by
Lidds AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Ongoing or previous hormone therapy for prostate cancer.
  2. On-going or previous therapy within 12 month of finasteride or dutasteride.
  3. On-going or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
  4. Use of pace maker or other electronic devices
  5. Symptoms or signs of acute prostatitis.
  6. Symptoms or signs of ulcered proctitis
  7. Severe micturation symptoms
  8. On-going therapy with anticoagulant (e.g Warfarin. Other anticoagulant should be withdrawn 1 week before injection).
  9. Concomitant systemic treatment with corticosteroids, or immune modulating agents.
  10. Known immunosuppressive disease (e.g. HIV, diabetes).
  11. 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.

Sites / Locations

  • Dept of Urology, University Hospital
  • Dept of Urology, University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liproca Depot

Arm Description

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.

Outcomes

Primary Outcome Measures

Characterization and quantification of histopathological measurement of tumour tissue obtained from diagnostic biopsy.
Characterization and quantification of histopathological measurement of tumour tissue in surgical specimens obtained from patients undergoing prostatectomy
The diffusion/flow of tissue water (ADC) before and after treatment assessed by diffusion-weighted imaging (MRI)

Secondary Outcome Measures

Concentration of Choline, Creatinine and Citrate in tumour tissue before and after treatment
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
Concentration of Plasma Prostate Specific Antigen (PSA)
Total prostate volume by histopathology/MRI measúrements
Number of participants with Adverse Events as a measure of Safety and Tolerability
Number of abnormal, clinically relevant, parameters from laboratory analyses
Pharmacokinetics (Tmax and Cmax) of 2-hydroxyflutamide (2-HOF)

Full Information

First Posted
October 17, 2014
Last Updated
March 10, 2016
Sponsor
Lidds AB
Collaborators
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT02341404
Brief Title
A Study of 2-hydroxyflutamide (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lidds AB
Collaborators
Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liproca Depot
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
2-hydroxyflutamide (2-HOF)
Other Intervention Name(s)
Liproca Depot
Intervention Description
Two components are mixed, transferred to a syringe and administered with injection into the prostate
Primary Outcome Measure Information:
Title
Characterization and quantification of histopathological measurement of tumour tissue obtained from diagnostic biopsy.
Time Frame
Day 1
Title
Characterization and quantification of histopathological measurement of tumour tissue in surgical specimens obtained from patients undergoing prostatectomy
Time Frame
Six weeks
Title
The diffusion/flow of tissue water (ADC) before and after treatment assessed by diffusion-weighted imaging (MRI)
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Concentration of Choline, Creatinine and Citrate in tumour tissue before and after treatment
Time Frame
Six weeks
Title
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
Title
Concentration of Plasma Prostate Specific Antigen (PSA)
Time Frame
Six weeks
Title
Total prostate volume by histopathology/MRI measúrements
Time Frame
Six weeks
Title
Number of participants with Adverse Events as a measure of Safety and Tolerability
Time Frame
Six weeks
Title
Number of abnormal, clinically relevant, parameters from laboratory analyses
Time Frame
Six weeks
Title
Pharmacokinetics (Tmax and Cmax) of 2-hydroxyflutamide (2-HOF)
Time Frame
Six weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dept of Urology, University Hospital
City
Tampere
Country
Finland
Facility Name
Dept of Urology, University Hospital
City
Uppsala
ZIP/Postal Code
756 53
Country
Sweden

12. IPD Sharing Statement

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

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