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NCT04943536 · ClinicalTrials.gov registry record · Phase 1

Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer

A Phase 1 study of Prostate Adenocarcinoma, sponsored by Alessa Therapeutics.

Active
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT04943536: Active Phase 1 study of Prostate Adenocarcinoma, sponsored by Alessa Therapeutics.

NCT04943536 is a Phase 1 study of Prostate Adenocarcinoma that is active but no longer recruiting, run by Alessa Therapeutics. The registered enrollment target is 20 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04943536, a Phase 1 study of Prostate Adenocarcinoma, is active but no longer recruiting, sponsored by Alessa Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Ability to successfully implant the prostate with Biolen and a lack of implant toxicity that interferes with the capacity to complete intended radiation therapy.

Conditions Studied

Interventions

  • RADIATION Stereotactic body radiation therapy
  • DRUG bicalutamide

Study Locations (1)

Maryland

  • National Cancer Institute - Bethesda

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-12-07
Est. Completion 2027-08-15
Phase Phase 1
Alessa Therapeutics

3 total trials

What the registry record for NCT04943536 still lists

NCT04943536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Stereotactic body radiation therapy is the first listed.

NCT04943536 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT04943536 about?

NCT04943536 is a clinical study titled "Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer". 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.

What is the current status of trial NCT04943536?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-12-07. Estimated completion is 2027-08-15.

What conditions does trial NCT04943536 study?

This clinical trial studies the following conditions: Prostate Adenocarcinoma.

What interventions are being tested in trial NCT04943536?

The interventions under investigation include: Stereotactic body radiation therapy (RADIATION), bicalutamide (DRUG).

Who is sponsoring clinical trial NCT04943536?

This trial is sponsored by Alessa Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04943536 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Prostate Adenocarcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04943536's enrollment target sits among peer trials

20 85th of 99 higher than 12 of 99 other Prostate Adenocarcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Adenocarcinoma 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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Source: ClinicalTrials.gov NCT04943536, the US trial registry maintained by the National Library of Medicine. NCT04943536 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.