Clinical trial NCT02341404: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Lidds AB
Sponsor class: INDUSTRY
Collaborators: name: Uppsala University
First posted: 2015-01-19
Enrollment: 23
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Characterization and quantification of histopathological measurement of tumour tissue obtained from diagnostic biopsy.
timeFrame: Day 1
measure: Characterization and quantification of histopathological measurement of tumour tissue in surgical specimens obtained from patients undergoing prostatectomy
timeFrame: Six weeks
measure: The diffusion/flow of tissue water (ADC) before and after treatment assessed by diffusion-weighted imaging (MRI)
timeFrame: Six weeks
Secondary outcomes:
measure: Concentration of Choline, Creatinine and Citrate in tumour tissue before and after treatment
timeFrame: Six weeks
measure: 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
timeFrame: Six weeks
measure: Concentration of Plasma Prostate Specific Antigen (PSA)
timeFrame: Six weeks
measure: Total prostate volume by histopathology/MRI measúrements
timeFrame: Six weeks
measure: Number of participants with Adverse Events as a measure of Safety and Tolerability
timeFrame: Six weeks
measure: Number of abnormal, clinically relevant, parameters from laboratory analyses
timeFrame: Six weeks
measure: Pharmacokinetics (Tmax and Cmax) of 2-hydroxyflutamide (2-HOF)
timeFrame: Six weeks
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Dept of Urology, University Hospital
city: Uppsala
country: Sweden
facility: Dept of Urology, University Hospital
Study officials:
References: