Clinical trial · Interventional
A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
NCT04284761CI-TRIAL-00078162Biolen-PCcompletedPhase 1ClinicalTrials.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)
Biolen, a novel implant, is intended to deliver an anti-androgen locally to the prostate gland for the management of prostate disease, while minimizing systemic exposure and its associated side-effects. The objectives of the study are to assess whether the Biolen is safe.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lower Urinary Tract Symptoms | — | UNRESOLVED | — |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide implant | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biolen
- description
- Biolen bicalutamide implant. Single implantation. In situ until prostatectomy
- interventionNames
- Combination Product: Bicalutamide implant
Primary outcomes (1)
- measure
- Safety as measured by number and incidence of adverse events
- timeFrame
- change from baseline to radical prostatectomy up to 12 weeks after implantation
- description
- Adverse Events
Secondary outcomes (3)
- measure
- change in prostate size
- timeFrame
- change from baseline to radical prostatectomy up to 12 weeks after implantation
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate. * Study participant qualified and planning for radical prostatectomy. * At least 1 prostate lesion measurable by MRI \> 0.5 cm within one month of screening. * PSA \> 3 ng/mL within 3 months of screening. * Gleason score 3+4 or higher. * Study participant must be willing to undergo post-treatment imaging by MRI. * ECOG performance status 0 or 1. Exclusion Criteria: * Prior radiotherapy or surgery for prostate cancer. * Prior or ongoing hormonal therapy for prostate cancer. * Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive BPH procedure. * Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc. * Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images. * Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3 months of screening or total use within the last two years prior to screening of \> 3 months. * Presence of any metastatic disease. * Prostate volume more than 80 cc at prior MRI imaging. * I-PSS score \>20. * History of prostate infection.
References
Publications (0)
Data not yet available
No reference posted for this study.