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A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

StatusRecruiting
PhasePhase 4
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 3 versions Re-verified since May 15, 2026, no change to tracked fieldsv47-v49
  2. Notable Primary and study completion dates: Jan 28, 2026 to Apr 29, 2027 Site details revised at 5 of 25 sitesv46 Show 1 more changeShow less
    • Site details revised at 5 of 25 sites
  3. Minor Study sites revised (25)v45 See this version in full on ClinicalTrials.gov ↗
  4. Minor Re-verified, no change to tracked fieldsv44
  5. Minor Site details revised at 1 of 25 sitesv43
Show 41 earlier versionsHide 41 earlier versions
  1. Minor Site details revised at 4 of 25 sitesv42
  2. Minor Site details revised at 2 of 25 sitesv41
  3. Minor Site details revised at 2 of 25 sitesv40
  4. Minor Re-verified, no change to tracked fieldsv39
  5. Minor Site details revised at 3 of 25 sitesv38
  6. Minor 2 versions Re-verified since Feb 5, 2025, no change to tracked fieldsv36-v37
  7. Minor Site details revised at 1 of 25 sitesv35
  8. Minor Primary endpoints revised (8)v34 See this version in full on ClinicalTrials.gov ↗
  9. Minor 3 versions Re-verified since Sep 2, 2024, no change to tracked fieldsv31-v33
  10. Minor Study sites revised (25)v30 See this version in full on ClinicalTrials.gov ↗
  11. Minor 4 versions Re-verified since Apr 7, 2024, no change to tracked fieldsv26-v29
  12. Minor Study sites: 23 to 25v25
  13. Minor Site details revised at 8 of 23 sitesv24
  14. Notable Primary and study completion dates: Sep 27, 2024 to Jan 28, 2026v23
  15. Minor Site details revised at 1 of 23 sitesv22
  16. Minor 2 versions Re-verified since Oct 10, 2023, no change to tracked fieldsv20-v21
  17. Minor Site details revised at 1 of 23 sitesv19
  18. Minor Site details revised at 3 of 23 sitesv18
  19. Minor Re-verified, no change to tracked fieldsv17
  20. Notable Primary and study completion dates: Jan 2, 2024 to Sep 27, 2024v16
  21. Minor Primary and study completion dates: Sep 27, 2024 to Jan 2, 2024v15
  22. Notable Primary and study completion dates: Feb 26, 2024 to Sep 27, 2024 Site details revised at 2 of 23 sitesv14 Show 1 more changeShow less
    • Site details revised at 2 of 23 sites
  23. Minor Site details revised at 1 of 23 sitesv13
  24. Notable Primary and study completion dates: Aug 30, 2023 to Feb 26, 2024v12
  25. Minor Site details revised at 1 of 23 sitesv11
  26. Minor Site details revised at 2 of 23 sitesv10
  27. Minor Eligibility criteria expanded, about 100 words Secondary endpoints revised (4)v9 Show 1 more changeShow less
    • Secondary endpoints revised (4)

    See this version in full on ClinicalTrials.gov ↗

  28. Minor Site details revised at 1 of 23 sitesv8
  29. Minor Re-verified, no change to tracked fieldsv7
  30. Notable Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Apr 5, 2023 to Aug 30, 2023 · Start date changed from estimate of Aug 5, 2022 to Aug 3, 2022 · Site details revised at 23 of 23 sitesv6 Show 3 more changesShow less
    • Primary and study completion dates: Apr 5, 2023 to Aug 30, 2023
    • Start date changed from estimate of Aug 5, 2022 to Aug 3, 2022
    • Site details revised at 23 of 23 sites
  31. Notable Start date: Jul 1, 2022 to Aug 5, 2022v5
  32. Minor Primary and study completion dates: Jun 30, 2023 to Apr 5, 2023 Start date: Jun 10, 2022 to Jul 1, 2022v4 Show 1 more changeShow less
    • Start date: Jun 10, 2022 to Jul 1, 2022
  33. Notable Start date: May 9, 2022 to Jun 10, 2022v3
  34. Notable Primary endpoints revised (8) Study sites: 20 to 23v2 Show 1 more changeShow less
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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Researchers are looking for a better way to treat men who have non-metastatic castration-resistant prostate cancer (nmCRPC). This is a type of cancer of the prostate that has not yet spread to other parts of the body and that keeps progressing even when the amount of male sex hormones like testosterone (also called androgens) is reduced to very low levels. To reduce androgen levels in prostate cancer patients, androgen deprivation therapy (ADT) is often used. As androgens stimulate the growth of prostate cancer cells, low levels are needed to reduce or slow the growth of these tumors. In men with nmCRPC, the cancer worsens despite low testosterone levels (also called castration resistant). Prostate-specific antigen (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. The study treatment darolutamide is already available in certain countries for doctors to prescribe to men with prostate cancer that has not yet spread to other parts of the body. It works by blocking androgens from attaching to proteins in cancer cells in the prostate. Results of a previous study in men with high-risk nmCRPC who received darolutamide in addition to ADT are already available, but this study had no Indian patients and was not conducted in India. Therefore, the main purpose of this study is to learn how safe darolutamide is when taken in addition to ADT in Indian participants with high-risk nmCRPC. To answer this question, the researchers will collect all medical problems the participants have that arise during the study and that may or may not be related to the study treatment. These medical problems are also known as "adverse events" (AE). The following information regarding safety of darolutamide will be collected during the study: * the number and severity of AEs that are non-serious or serious * the number of participants who have to permanently stop the treatment due to AEs * the number of participants who have to change the amount of study drug taken due to AEs AEs can be: * abnormal results of laboratory tests, physical examinations, or heart health examinations using ECG (detects heart problems by measuring the electrical activity generated by the heart as it contracts). * relevant changes in vital signs * relevant changes of the participant's daily living abilities (ECOG performance status) These results will then be compared with the results from the previous study to identify any differences for this group of participants. In addition, researchers will collect and compare data on how well darolutamide worked under real world conditions in this group of participants. All participants will take darolutamide as tablets by mouth twice a day. The participants will visit the study center at the start of the study, and then every 16 weeks until their cancer gets worse, they develop medical problems, they leave the study or until the study is terminated. During the study, the study team will * take blood and urine samples * do physical examinations * check vital signs * examine heart health using ECG * assess the participant's ECOG performance status * ask the participants questions about how they are feeling and what AEs they are having. If the trial is stopped, participants may have the option to continue to receive darolutamide, provided they benefit from the treatment
Trial Details
NCT Number NCT05348876
Lead Sponsor Bayer
Conditions Non-metastatic Castration-resistant Prostate Cancer
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov