Observing the safety and effectiveness of darolutamide with hormone therapy and chemotherapy for Japanese men with low-volume metastatic prostate cancer
An Observational Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Low-volume Metastatic Hormone-sensitive Prostate Cancer
This study looks at how safe and effective a combination of darolutamide, hormone therapy, and chemotherapy is for Japanese men with low-volume metastatic prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Bayer Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT06661122 on ClinicalTrials.gov |
What this trial studies
This observational study collects and analyzes medical records of Japanese men diagnosed with low-volume metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with a combination of darolutamide, androgen deprivation therapy (ADT), and docetaxel. The aim is to understand the safety and effectiveness of this treatment regimen in routine medical care. Darolutamide is known to block androgen signals, while ADT lowers testosterone levels, and docetaxel is a chemotherapy agent that inhibits cancer cell growth. By studying these patients, the research seeks to improve treatment decisions for this specific cancer population.
Who should consider this trial
Good fit: Ideal candidates include Japanese men with histologically confirmed adenocarcinoma of the prostate and low-volume metastatic disease.
Not a fit: Patients with high-volume metastatic disease or those not receiving the specified treatment regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into optimizing treatment strategies for men with low-volume metastatic hormone-sensitive prostate cancer.
How similar studies have performed: While darolutamide has been studied in other contexts, this specific combination therapy for low-volume mHSPC is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 \[NCT06010914\]).
Where this trial is running
Multiple Locations
- Many locations — Multiple Locations, Japan (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.