A Dose Finding Study of Debio 4228 in Participants With Locally Advanced/Metastatic Prostate Cancer

Description

The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.

Conditions

Prostate Cancer

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Study Overview

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Study Details

Study overview

The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.

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

A Dose Finding Study of Debio 4228 in Participants With Locally Advanced/Metastatic Prostate Cancer

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Tower Urology,, Los Angeles, California, United States, 90048

Miami

Biogenix Molecular, Miami, Florida, United States, 33165

Jeffersonville

First Urology- Jeffersonville, Jeffersonville, Indiana, United States, 47130

Wichita

GU Research Network/Wichita Urology Group, Wichita, Kansas, United States, 67226

Shirley

New York Cancer and Blood Specialists, Shirley, New York, United States, 11697

Raleigh

Associated Urologists of North Carolina, Raleigh, North Carolina, United States, 27612

Springfield

Oregon Urology Institut, Springfield, Oregon, United States, 97477

Myrtle Beach

Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States, 29572

Dallas

Urology Clinics of North Texas, Dallas, Texas, United States, 75231

Virginia Beach

Urology of Virginia, Virginia Beach, Virginia, United States, 23462

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Participant with histologically confirmed locally advanced/metastatic prostate cancer
  • 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
  • 1. Previous ADT (neoadjuvant or adjuvant hormonal therapy) for ≥6 months duration and \<6 months treatment-free interval before start of screening
  • 2. Indication for androgen deprivation combination therapy
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Debiopharm International SA,

Study Record Dates

2026-04