RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-05-23

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06395753

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Debiopharm International S.A

CONTACT

+41 21 321 01 11

clinicaltrials@debiopharm.com

Study Locations (Sites)

Tower Urology,

Los Angeles, California, 90048

United States

Biogenix Molecular

Miami, Florida, 33165

United States

First Urology- Jeffersonville

Jeffersonville, Indiana, 47130

United States

GU Research Network/Wichita Urology Group

Wichita, Kansas, 67226

United States

New York Cancer and Blood Specialists

Shirley, New York, 11697

United States

Associated Urologists of North Carolina

Raleigh, North Carolina, 27612

United States

Oregon Urology Institut

Springfield, Oregon, 97477

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

United States

Urology Clinics of North Texas

Dallas, Texas, 75231

United States

Urology of Virginia

Virginia Beach, Virginia, 23462

United States

Summit Cancer Centers of North Spokane

Spokane, Washington, 99208

United States

Collaborators and Investigators

Sponsor: Debiopharm International SA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-23

Study Completion Date2026-04

Study Record Updates

Study Start Date2024-05-23

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer