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A Dose Finding Study of Debio 4228 in Participants With Advanced Prostate Cancer
EU CTIS ID: 2024-511038-11-00
What this study is testing
To determine the PK/PD of Debio 4228
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant with histologically confirmed diagnosis of prostate cancer, with one of the following: a. Newly diagnosed androgen-sensitive locally advanced or metastatic disease; b. Localized disease not suitable for local primary intervention with curative intent.
- Participant judged by the Study Investigator to be candidate for continuous ADT
- Baseline morning serum testosterone levels >150 ng/dL at screening visit
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy of at least 6 months
You likely can't join if
- Previous ADT (neoadjuvant or adjuvant hormonal therapy) for ≥6 months duration and <6 months treatment-free interval before start of screening
- Participant requires combination with androgen deprivation therapy with the exception of enzalutamide
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- Received chemotherapy or cryotherapy within 8 weeks prior to the start of screening for the treatment of prostate cancer
- Abnormal cardiovascular function or diabetes
- Use of exogenous testosterone within 6 months before the start of screening
See the full eligibility criteria
- Participant with histologically confirmed diagnosis of prostate cancer, with one of the following: a. Newly diagnosed androgen-sensitive locally advanced or metastatic disease; b. Localized disease not suitable for local primary intervention with curative intent.
- Participant judged by the Study Investigator to be candidate for continuous ADT
- Baseline morning serum testosterone levels >150 ng/dL at screening visit
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy of at least 6 months
- Adequate bone marrow, hepatic, and renal function at the screening visit
- Other protocol and subprotocol defined criteria apply.
- Previous ADT (neoadjuvant or adjuvant hormonal therapy) for ≥6 months duration and <6 months treatment-free interval before start of screening
- Participant requires combination with androgen deprivation therapy with the exception of enzalutamide
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- Received chemotherapy or cryotherapy within 8 weeks prior to the start of screening for the treatment of prostate cancer
- Abnormal cardiovascular function or diabetes
- Use of exogenous testosterone within 6 months before the start of screening
- Major surgery within 4 weeks before the start of screening
- Cancer disease within the last two years except for prostate cancer and some skin cancers
- Other protocol and subprotocol-defined criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.