Clinical trial · Interventional
Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
NCT04943536CI-TRIAL-00104230BiolenRTactive not recruitingPhase 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)
This study will be undertaken to evaluate the feasibility of replacing systemic Androgen Deprivation Therapy (ADT) with targeted local delivery of an anti-androgen agent alone in patients in whom ADT + radiation therapy is indicated for the treatment of 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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bicalutamide | Drug | Bicalutamide | ALIAS |
| Stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biolen+Radiation Therapy
- description
- Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy
- interventionNames
- Drug: bicalutamide
- Radiation: Stereotactic body radiation therapy
Primary outcomes (1)
- measure
- Feasibility of replacing systemic androgen tx with targeted local delivery
- timeFrame
- 27 months
- description
- Ability to successfully implant the prostate with Biolen and a lack of implant toxicity that interferes with the capacity to complete intended radiation therapy.
Secondary outcomes (3)
- measure
- Adverse Events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with biopsy proven localized prostate cancer in whom prostate radiation and ADT is appropriate therapy (such as Intermediate Risk localized prostate cancer) * Patients must have at least 1 MRI detected; biopsy proven prostate cancer. * Patients diagnosed as one of the following: 1. National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer, OR 2. NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, OR 3. NCCN high risk prostate cancer due to Prostate Specific Antigen (PSA) \> 20 AND refuses to receive systemic ADT. * Age \>18 years. Exclusion Criteria: * NCCN high risk patients eligible for treatment with systemic ADT who do not refuse systemic ADT. * Patients receiving prior radiotherapy or surgery for prostate cancer. * Patients receiving prior or ongoing ADT. * 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. * 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. * Prostate volume more than 80 cc at prior MRI imaging. * International Prostate Symptom Score ≥ 20.
References
Publications (0)
Data not yet available
No reference posted for this study.