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New shot could tame prostate cancer by blocking testosterone

NCT ID NCT06395753

Disease control Sponsor: Debiopharm International SA 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Updated 4 times

Summary

This study tests a new long-acting injection called Debio 4228 for men with advanced prostate cancer. The goal is to lower testosterone levels to control the cancer. About 55 men will receive different doses to find the best one. This is not a cure, but a way to manage the disease long-term.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

55 people

The number who actually took part.

Started

May 2024

Finished

Jul 2026

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: 1. Participant with histologically confirmed diagnosis of prostate cancer, with one of the following: 1. Newly diagnosed androgen-sensitive locally advanced or metastatic disease; or 2. Localized disease not suitable for local primary intervention with curative intent. 2. Participant judged by the Study Investigator to be candidate for continuous androgen deprivation therapy (ADT). 3. Baseline morning serum testosterone levels \>150 ng/dL at screening visit. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Life expectancy of at least 6 months. 6. Adequate bone marrow, hepatic, and renal function at the screening visit. \[Note: Other protocol and subprotocol-defined criteria apply\] Exclusion Criteria: 1. Previous ADT (neoadjuvant or adjuvant hormonal therapy) for ≥6 months duration and \<6 months treatment-free interval before start of screening. 2. Participant requires combination with androgen deprivation therapy with the exception of enzalutamide. 3. History of bilateral orchiectomy, adrenalectomy, or hypophysectomy. 4. Received chemotherapy or cryotherapy within 8 weeks prior to the start of screening for the treatment of prostate cancer. 5. Abnormal cardiovascular function or diabetes. 6. Use of exogenous testosterone within 6 months before the start of screening. 7. Major surgery within 4 weeks before the start of screening. 8. Cancer disease within the last two years except for prostate cancer and some skin cancers. \[Note: Other protocol and subprotocol-defined criteria apply\]

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

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

Prostate cancer

Contacts and locations

Locations

  • Alarcon Urology Center

    Montebello, California, 90640, United States

  • Bakersfield Institute of Advanced Urology

    Bakersfield, California, 93301, United States

  • Biogenix Molecular

    Miami, Florida, 33165, United States

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093, France

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Centre Georges Francois Leclerc

    Dijon, 21000, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • East Valley Urology Center of Arizona

    Queen Creek, Arizona, 85140, United States

  • Grimaldi Urology

    Chula Vista, California, 91910, United States

  • Hospital Clinic Barcelona

    Barcelona, 8036, Spain

  • Hospital Clinico San Carlos

    Madroñera, 28040, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Oregon Urology Institut

    Springfield, Oregon, 97477, United States

  • Summit Cancer Centers of North Spokane

    Spokane, Washington, 99208, United States

  • Tower Urology,

    Los Angeles, California, 90048, United States

  • Urologic Surgeons of Arizona

    Mesa, Arizona, 85206, United States

  • Urology Center of Southern California

    Murrieta, California, 92563, United States

  • Urology of Virginia

    Virginia Beach, Virginia, 23462, United States

  • Valley Urology

    Fresno, California, 93722, United States

More trials for these conditions

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