Clinical trial · Interventional
A Study of 2-hydroxyflutamide (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer
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
NCT02341404CI-TRIAL-00021330completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2-hydroxyflutamide (2-HOF) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Liproca Depot
- 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.
- interventionNames
- Drug: 2-hydroxyflutamide (2-HOF)
Primary outcomes (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.