Clinical Study of I-DXd Compared to Docetaxel in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Zusammenfassung der Studie

This Phase 3 study investigates the efficacy and safety of the drug I-DXd compared to Docetaxel (standard therapy) in patients with advanced castration-resistant prostate cancer (www.clinicaltrialsregister.eu; number 2024-517423-40). • Ifinatamab Deruxtecan (I-DXd) is an antibody-drug conjugate consisting of an antibody and chemotherapy. The antibody targets a protein on tumor cells, allowing the drug to directly reach and enter these tumor cells while largely sparing healthy cells. This aims to reduce the side effects of chemotherapy while effectively combating tumor cells. • Docetaxel is a chemotherapy that works by inhibiting the growth and division of cancer cells. Docetaxel is typically administered intravenously and can help slow disease progression and reduce tumor size. Approximately 1440 patients are expected to participate in this study worldwide, with about 20 from Switzerland. The total study duration is approximately 5.5 years.

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Untersuchte Intervention

After thorough information, detailed eligibility assessment, medical history collection, and comprehensive explanation, participants will be included in the study and randomly assigned to one of the two treatment groups.

Group 1: Ifinatamab Deruxtecan (I-DXd)

Group 2: Docetaxel + Prednisone/Prednisolone

The probability of being assigned to Group 1 or 2 is equal, and both participants and study doctors know which treatment is being administered.

After a screening phase of up to 6 weeks (42 days), each participant receives the assigned treatment. Participants in Group 1 receive treatment with I-DXd as long as the cancer does not worsen and the tested drug is well tolerated. Participants in Group 2 receive treatment with Docetaxel for up to about 7 months as long as the cancer does not worsen and the drug is well tolerated. The respective study drug is administered once on the first day of a 21-day treatment cycle via infusion.

After completing the treatment, participants will be monitored for a certain period.

During study visits, various measures and examinations may occur, e.g.: imaging procedures such as CT and MRI (computed or magnetic resonance imaging), electrocardiogram (ECG) - an examination to check the electrical activity of your heart, MUGA scans or echocardiogram (ECHO) - both examinations to assess your heart function, blood and urine tests, tumor biopsies, eye examinations, physical examinations including checking vital signs (pulse, blood pressure, etc.), answering questionnaires.

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Untersuchte Krankheit(en)

Prostate cancer is the most common cancer in men in Switzerland and Europe and the fifth leading cause of death. The disease usually occurs after the age of 65. Initially, the cancer grows slowly and often goes undetected. When prostate disease spreads to other parts of the body, it is referred to as advanced (metastatic) prostate cancer. While many men diagnosed with localized disease can be treated with radiation therapy or surgical procedures, those who develop metastatic prostate cancer are typically first treated with androgen deprivation therapy. Androgen deprivation therapy, or ADT, is a hormonal withdrawal treatment that can often control the disease for many years. If prostate cancer progresses despite this therapy, it is referred to as metastatic castration-resistant (mCRPC). Additional treatments must be used, such as androgen receptor pathway inhibitors (ARPI) or chemotherapy (e.g., Docetaxel). Currently, there is an urgent medical need for new treatment options that are more effective, delay disease progression, improve survival, and maintain quality of life.

(BASEC)

Sponsor

MSD Merck Sharp & Dohme AG, Lucerne, Switzerland Merck & Co., Inc., Rahway, NJ, USA

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

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Datum der Bewilligung durch die Ethikkommission

06.06.2025

(BASEC)

Ergebnisse der Studie