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Prostate cancer implant could replace systemic hormone shots

NCT ID NCT04943536

Disease control Sponsor: Alessa Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests whether a bicalutamide implant placed directly into the prostate can replace standard hormone shots for men with localized prostate cancer receiving radiation. About 20 participants with intermediate- or high-risk cancer will receive the implant plus radiation. The goal is to see if this targeted approach is safe and feasible, potentially reducing side effects from whole-body hormone therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate adenocarcinoma

Contacts and locations

Locations

  • National Cancer Institute

    Bethesda, Maryland, 20894, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.