A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer

Launched by BAYER · Oct 24, 2024

Keywords

ClinConnect Summary

This clinical trial is focusing on how safe and effective a combination treatment of darolutamide, androgen deprivation therapy (ADT), and docetaxel is for Japanese men with a specific type of prostate cancer called low-volume metastatic hormone-sensitive prostate cancer (mHSPC). This type of cancer has spread from the prostate gland to a few bones but has not affected other organs. The study will look at medical records of men who receive this combination treatment as part of their regular healthcare to see how well it works in controlling cancer and what side effects, if any, occur.

To participate in this study, men need to have a confirmed diagnosis of prostate cancer that meets certain criteria, including having low-volume metastasis. Participants will not have to make any extra visits; they will only go to their regular doctor for their treatments. The researchers will collect information over a year to see how many men achieve normal levels of a blood protein called PSA, which helps monitor prostate cancer, and to track any side effects from the treatment. This information will help improve treatment decisions for men with this type of prostate cancer in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically or cytologically confirmed adenocarcinoma of prostate.
• • Patients have low-volume of metastatic disease documented by either by a positive bone scan, or for soft tissue either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigator. Low-volume metastasis criteria is defined as "not" meeting the high-volume criteria of the CHAARTED trial; high-volume meet the presence of visceral metastases, or four or more bone lesions including at least one outside the vertebral column or pelvis.
• • Documented diagnosis of mHSPC.
• • Patients on triplet regimen previously decided by the investigator irrespective of enrollment in the study.
• • Start ADT within 6 months before or at the index date.
• • Signed informed consent: If an eligible patient is deceased at the time of study initiation, informed consent from the legally representative(s) of the patient is required. Opt-out consent is acceptable in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects only when it is difficult to obtain signed informed consent from the patient or their legal representative.
• Exclusion Criteria:
• • Patients treated with docetaxel before darolutamide start.
• • Participation in an investigational program with interventions outside of routine clinical practice.
• • Contra-indications to darolutamide, docetaxel and ADT according to the local marketing authorization.
• • Participation in the PASS of darolutamide in patients with mHSPC (DADOX \[NCT06010914\]).