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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341404
• Other study ID #: LPC-003
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2014
• Last updated: March 10, 2016
• Start date: May 2012
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: Lidds AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 2-hydroxyflutamide (2-HOF)
Two components are mixed, transferred to a syringe and administered with injection into the prostate

Locations

Country	Name	City	State
Finland	Dept of Urology, University Hospital	Tampere
Sweden	Dept of Urology, University Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Lidds AB	Uppsala University

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization and quantification of histopathological measurement of tumour tissue obtained from diagnostic biopsy.		Day 1	No
Primary	Characterization and quantification of histopathological measurement of tumour tissue in surgical specimens obtained from patients undergoing prostatectomy		Six weeks	No
Primary	The diffusion/flow of tissue water (ADC) before and after treatment assessed by diffusion-weighted imaging (MRI)		Six weeks	No
Secondary	Concentration of Choline, Creatinine and Citrate in tumour tissue before and after treatment		Six weeks	No
Secondary	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	No
Secondary	Concentration of Plasma Prostate Specific Antigen (PSA)		Six weeks	No
Secondary	Total prostate volume by histopathology/MRI measúrements		Six weeks	No
Secondary	Number of participants with Adverse Events as a measure of Safety and Tolerability		Six weeks	Yes
Secondary	Number of abnormal, clinically relevant, parameters from laboratory analyses		Six weeks	Yes
Secondary	Pharmacokinetics (Tmax and Cmax) of 2-hydroxyflutamide (2-HOF)		Six weeks	Yes