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NCT04284761 · ClinicalTrials.gov registry record · Phase 1
A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
A Phase 1 study, sponsored by Alessa Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT04284761: Completed Phase 1 study, sponsored by Alessa Therapeutics.
NCT04284761 is a Phase 1 study that has completed, run by Alessa Therapeutics. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04284761, a Phase 1 study, has completed, sponsored by Alessa Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Adverse Events
Interventions
- COMBINATION_PRODUCT Bicalutamide implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-10-11 |
| Est. Completion | 2023-05-03 |
| Phase | Phase 1 |
What the finished NCT04284761 record still lists
NCT04284761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Bicalutamide implant is the first listed.
NCT04284761 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04284761 about?
NCT04284761 is a clinical study titled "A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer". 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.
What is the current status of trial NCT04284761?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2020-10-11. Estimated completion is 2023-05-03.
What interventions are being tested in trial NCT04284761?
The interventions under investigation include: Bicalutamide implant (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04284761?
This trial is sponsored by Alessa Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04284761's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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