Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05362149 · ClinicalTrials.gov registry record
An Observational Study, Called DEAR, to Learn More About Treatment With Darolutamide, Enzalutamide and Apalutamide in Men With Non-metastatic Castration-resistant Prostate Cancer in Real World Settings
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 870
- Enrollment target
NCT05362149: Completed study, sponsored by Bayer.
NCT05362149 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 870 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05362149 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 870 participants
- Enrollment target
Study Summary
This is an observational study in which patient data from the past on men with non-metastatic castration-resistant prostate cancer are studied. In observational studies, only observations are made without specified advice or interventions. Non-metastatic castration-resistant prostate cancer (nmCRPC) is a type of cancer of the prostate that has not yet spread to other parts of the body, but that no longer responds adequately to initial hormone therapy/androgen deprivation therapy (ADT). Androgens are male sex hormones such as testosterone. As they stimulate the growth of prostate cancer cells, low androgen levels are needed to reduce or slow the growth of these tumors. To reduce androgen levels in prostate cancer patients, the testes are removed through surgery or radiotherapy and subsequently androgen deprivation therapy (ADT) is started. In men with nmCRPC, the cancer worsens despite low testosterone levels (also called castration resistant). This worsening is called "biochemical progression" as there is an increase in the blood level of cancer biomarkers, such as prostate specific antigen \[PSA\] without detectable disease. PSA is a protein that is made by both normal cells and by cancerous cells in the body. Thus, PSA levels can be taken as a marker for prostate cancer development. Men with nmCRPC usually have higher levels of PSA than normal. They are considered "high risk" if they show signs of quickly increasing PSA levels as this could mean that the tumor is growing and might spread to other parts of the body. Second generation androgen receptor inhibitors (SGARIs) including Darolutamide, Apalutamide, and Enzalutamide are available for the treatment of nmCRPC in addition to ADT. SGARIs work by blocking androgens from attaching to proteins in cancer cells in the prostate. It is already known that men with nmCRPC benefit from these treatments, but as men with nmCRPC commonly have no symptoms, an important therapeutic goal is to minimize side effects which
Interventions
- DRUG Apalutamide
- DRUG Enzalutamide
- DRUG Darolutamide (Nubeqa, BAY1841788)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 870 participants |
| Start Date | 2022-04-04 |
| Est. Completion | 2023-06-30 |
What the finished NCT05362149 record still lists
NCT05362149 is an observational study that tracks outcomes without assigning an intervention. The registered 870 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Apalutamide is the first listed.
NCT05362149 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05362149 about?
NCT05362149 is a clinical study titled "An Observational Study, Called DEAR, to Learn More About Treatment With Darolutamide, Enzalutamide and Apalutamide in Men With Non-metastatic Castration-resistant Prostate Cancer in Real World Settings". This is an observational study in which patient data from the past on men with non-metastatic castration-resistant prostate cancer are studied. In observational studies, only observations are made without specified advice or interventions. Non-metastatic castration-resistant prostate cancer (nmCRPC...
What is the current status of trial NCT05362149?
This trial is currently completed. The enrollment target is 870 participants. The study started on 2022-04-04. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT05362149?
The interventions under investigation include: Apalutamide (DRUG), Enzalutamide (DRUG), Darolutamide (Nubeqa, BAY1841788) (DRUG).
Who is sponsoring clinical trial NCT05362149?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04097145 · 870 participants · NA
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
- NCT06822790 · 869 participants · Phase 3
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
- NCT06077760 · 868 participants · Phase 3
A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
- NCT04933552 · 867 participants
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI