Testing Debio 4228 for advanced prostate cancer

A Phase 2, Randomized, Open-Label, Dose-Finding Study of Debio 4228, an Extended-Release Formulation of Gonadotropin-Releasing Hormone Antagonist in Participants With Advanced Prostate Cancer

This study is testing a new drug called Debio 4228 to see how well it works for people with advanced prostate cancer who are newly diagnosed or can't have surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Debiopharm International SA (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 27 sites (Bakersfield, California and 26 other locations)
• Trial ID: NCT06395753 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the pharmacokinetics and pharmacodynamics of Debio 4228 in participants with advanced prostate cancer. It focuses on patients who are newly diagnosed with androgen-sensitive locally advanced or metastatic disease, or those with localized disease not suitable for curative intervention. Participants will receive Debio 4228 while being monitored for their response to the treatment. The study seeks to determine the appropriate dosing and effectiveness of the drug in this patient population.

Who should consider this trial

Good fit: Ideal candidates include men with histologically confirmed advanced prostate cancer who are suitable for continuous androgen deprivation therapy.

Not a fit: Patients who have previously undergone prolonged androgen deprivation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer.

How similar studies have performed: While this approach is being explored, similar studies have shown promise in targeting advanced prostate cancer with novel therapies.

Eligibility criteria

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.

\[Note: Other protocol and subprotocol-defined criteria apply\]

Where this trial is running

Bakersfield, California and 26 other locations

• Bakersfield Institute of Advanced Urology — Bakersfield, California, United States (Recruiting)
• Valley Urology — Fresno, California, United States (Recruiting)
• Advanced Urology — Los Angeles, California, United States (Recruiting)
• Tower Urology, — Los Angeles, California, United States (Recruiting)
• Urology Center of Southern California — Murrieta, California, United States (Recruiting)
• AP Medical Research — Miami, Florida, United States (Recruiting)
• Biogenix Molecular — Miami, Florida, United States (Recruiting)
• First Urology- Jeffersonville — Jeffersonville, Indiana, United States (Recruiting)
• GU Research Network/Wichita Urology Group — Wichita, Kansas, United States (Recruiting)
• New York Cancer and Blood Specialists — Shirley, New York, United States (Recruiting)
• Associated Urologists of North Carolina — Raleigh, North Carolina, United States (Recruiting)
• Oregon Urology Institut — Springfield, Oregon, United States (Recruiting)
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (Recruiting)
• Urology Clinics of North Texas — Dallas, Texas, United States (Recruiting)
• Urology of Virginia — Virginia Beach, Virginia, United States (Recruiting)
• Summit Cancer Centers of North Spokane — Spokane, Washington, United States (Recruiting)
• University Hospital Gent — Gent, Belgium (Not_yet_recruiting)
• AZ Groeninge — Kortrijk, Belgium (Recruiting)
• AZ Delta — Roeselare, Belgium (Recruiting)
• CHU Angers — Angers, France (Not_yet_recruiting)
• CHRU de Brest - Hopital Morvan — Brest, France (Not_yet_recruiting)
• Centre Jean Perrin — Clermont-Ferrand, France (Recruiting)
• CHU de Nantes - Hôtel Dieu — Nantes, France (Recruiting)
• Hospital Universitario Vall d'Hebron — Barcelona, Spain (Recruiting)
• Hospital Clinico San Carlos — Madroñera, Spain (Recruiting)
• Corporacio Sanitaria Parc Tauli - Hospital de Sabadell — Sabadell, Spain (Recruiting)
• Instituto Valenciano de Oncologia — Valencia, Spain (Recruiting)

Study contacts

• Study coordinator: Debiopharm International S.A

Conditions Prostate Cancer