Non-metastatic Castration-resistant Prostate Cancer Clinical Trial
Official title:
A Single-arm, Open-label Phase 4 Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy for Participants in India With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)
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.
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