Clinical trial · Interventional
A Study to Evaluate the Safety, Tolerability and Efficacy of a Liproca® Depot Injection in Patients With Prostate Cancer
A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection Into the Prostate in Patients With Localized Prostate Cancer, Assigned to Active Surveillance Who Are at High Risk for Disease Progression (Followed by an Open Label Extension With a Repeat Injection (Optional)).
- 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)
A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer,Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a Repeat Injection (Optional))
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 Depot | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Stage I: Dose = 35% of prostate volume
- description
- Subject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 35 % of their prostate volume.
- interventionNames
- Drug: 2-Hydroxyflutamide Depot
- type
- EXPERIMENTAL
- label
- Stage I: Dose = 45% of prostate volume
- description
- Subject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 45 % of their prostate volume.
- interventionNames
- Drug: 2-Hydroxyflutamide Depot
- type
- EXPERIMENTAL
- label
- Stage II: Dose = 16mL
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria:
* Signed informed consent prior to any study specific procedures being performed
* 18 - 80 years of age, inclusive
* Assigned to Active Surveillance
* Histologically confirmed, localized prostate cancer within 24 months of Screening
* Gleason score 3+3 or 3+4 with one or more of the following characteristics:
PSA \> 6.0 μg/L (ng/mL) and PSA density \> 0.15; PSA \> 10.0 μg/L and \< 20 μg/L (ng/mL); Any systematic core \> 50% involvement; Any PI-RADS score 4 or 5 on MRI; Any Gleason grade 4, Men of African descent
* Patient has a negative bone scan within the last 12 months
* Patient is able to have an MRI
* Prostate volume ≤ 80 mL (measured by MRI within 12 months of Screening or has been scheduled for an MRI prior to Screening)
* eGFR ≥ 30 mL/min, using the Cockcroft - Gault Equation: = \[{(140 - age in years) x (weight in kg)} x 1.23\] / serum Creatinine in micromol/l
* AST, ALT and ALP ≤ 1.5 times upper limit of normal
* Patient must be willing to comply with all study procedures
* Patients must agree to the use of medically acceptable methods of contraception, including non-hormonal intrauterine device (IUD) or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide) for the duration of the study (24 weeks), unless the patient and/or their partner has been surgically sterilized
Exclusion Criteria:
* PSA \> 20 μg/L (ng/mL)
* Previous or ongoing hormonal therapy for prostate cancer
* Positive urine culture before treatment with prophylactic antibiotics
* Ongoing or previous therapy with finasteride or dutasteride in the last 3 months
* Ongoing or previous invasive therapy for benign prostate hyperplasia (BPH) (e.g. TURP,TUMT, HIFU, etc.)
* Use of pacemaker or other implanted electronic devices
* Metal implant in the pelvis (e.g. hip replacement) that may affect the MRI of the prostate
* Allergy to Liproca® Depot and its ingredients
* Severe micturition symptoms (I-PSS \>15 or residual urine volume \> 150 mL) confirmed by repeat measurement or Qmax\< 12 mL/s
* Ongoing therapy with the anticoagulant Acetyl Salicylic Acid (ASA) (more than 100mg/day) as preventive anti-thrombotic therapy should be withdrawn temporarily before treatment with Liproca® Depot, as determined by the Investigator. Other anticoagulants should be withdrawn in cooperation with the treating physician
* Use of any previous focal prostate cancer treatment, such as transurethral resection, cryotherapy, high intensity frequency ultrasound (HIFU) and/or photodynamic therapy
* Concomitant systemic treatment with corticosteroids or immune modulating agents
* Known immunosuppressive disease (e.g. HIV, Type II Diabetes). Patients with well controlled Type II Diabetes may be included, as determined by Investigator
* Simultaneous participation in any other study involving an investigational product or device,or having participated in a prostate cancer study within the last 12 months prior to starting treatment with Liproca® Depot
* Infection in WHO Risk Group 2, 3 or 4References
Publications (0)
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