12 Clinical Trials for Various Conditions
This is an observational cohort study in men with non-metastatic castration-resistant prostate cancer who received their usual treatment, which is 'Androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide. The main purpose of this study is to collect data on the length of time men with nmCRPC continued treatment with darolutamide, enzalutamide, or apalutamide as prescribed by their doctors. Researchers will only include men who had not been treated with any new type of medication that blocks the action of hormones. The data will come from an electronic health record database called Precision Point Specialty (PPS) Prostate Cancer Electronic Medical Record (EMR) for men in the United States of America. EMR data will be verified and supplemented via patient chart review. Data collected will be from January 2019 to September 2023. .
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 can impact the patients' quality of life and potentially lead to the patient stop the treatment. Comparative studies using data from the same database to show how treatment with Darolutamide, Apalutamide, and Enzalutamide differ from each other, are missing. In addition, there are only limited information regarding using Darolutamide, Apalutamide, and Enzalutamide in real-world settings. In this study data are collected from the same database to learn how Darolutamide, Enzalutamide and Apalutamide are used and how safe they are under real world conditions in men with nmCRPC, who had not been treated before with SGARI or another drug called abiraterone. The main purpose is to learn to what extent SGARI treatments are taken as prescribed. To find this out, the researchers will count the number of participants who have stopped their treatment with Darolutamide, Enzalutamide or Apalutamide at or before: * 6 months * 12 months * 18 months of treatment in usual practice. In addition, characteristics of each participant group and the reason for discontinuation (stopping the treatment) will be collected and described. The researchers will also collect any medical problems during treatment and up to 30 days after stopping the treatment and that may or may not be related to the study treatment. These medical problems are also known as "adverse events" (AE). The data for this study will come from the US urology EMR ( Electronic Medical Record) database. This study will include all US patients identified in the Precision Point Specialty (PPS) urology electronic medical record (EMR) database between August 1, 2019 and September 30, 2021. The researchers will collect data from each patient for a minimum of 6 months after initiation of the SGARI treatment and up to the end of the study (March 31, 2022) or latest data cut available at the start of data extraction. There are no required visits in this study and treatment will not be influenced.
The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice.
The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.
The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.
This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without radiographic evidence of metastases who have a rising prostate-specific antigen (PSA).
This is an observational study in which data will be collected and studied from men with non-metastatic prostate cancer (nmPC) who received their usual treatment with 'androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide. Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Non-metastatic means that cancer has not yet spread to other parts of the body. Darolutamide, enzalutamide, and apalutamide are already approved ARIs for nmPC in the United States (US). They work by blocking androgens (male sex hormones including testosterone) from attaching to proteins in cancer cells in the prostate. This helps to slow down the growth of the cancer cells. The participants will receive their treatments as prescribed by their doctors during routine medical care according to the approved product information. Researchers want to know more about the use of ARIs and how they affect men with nmPC in the real world. Researchers will only include men who have not been treated with any new type of medication that blocks the action of male sex hormones. The main purpose of this study is to collect and study information from men with nmPC about: * the length of time they continued treatment with an ARI as prescribed by their doctors. * the length of time from the start of the treatment with an ARI until the cancer spreads to other parts of the body. Data will come from the participants' information stored in a database called Komodo Research Dataset (KRD) in the US. The data collected will be from May 2019 to June 2023. Researchers will only track data of eligible US men with nmPC and will follow them for a minimum of 6 months or until the end of the study.
This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).
This research is being done to test the safety and anti-cancer activity of the combination of an investigational drug called orteronel, with a drug called itraconazole in the treatment of castration-resistant prostate cancer. Orteronel is an investigational drug known as a 17,20-lyase enzyme inhibitor, meaning that it blocks the formation of male sex hormones. Itraconazole is approved by the Food and Drug Administration (FDA) for the treatment of various fungal infections such as fingernail/toenail infections and other more serious fungal infections. While it has shown evidence of activity against prostate cancer in prior studies, it is not approved for use in cancer. The FDA is allowing the use of orteronel and itraconazole in this research study. In addition to its antifungal properties, itraconazole was discovered to function to block angiogenesis (blood vessel formation to tumors) to block a cellular pathway thought to be important in prostate cancer known as the Hedgehog pathway. Investigators hypothesize that blocking male sex hormone production with orteronel will increase reliance on the Hedgehog pathway in prostate cancer cells which can then be blocked with itraconazole and that the combination of these two drugs will be more effective than either alone.
The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1 of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase 2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of ARN-509.
This is a Phase 1, open-label, multicenter study of KPG-121 administered orally once daily (QD) in 28-day treatment cycles to adult subjects.