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Showing 1-6 of 6 trials
NCT06661122
This is an observational study in which medical records of Japanese men with low-volume metastatic hormone-sensitive prostate cancer (mHSPC), who received treatment with a combination therapy of darolutamide with an androgen deprivation therapy (ADT) and docetaxel, will be collected and studied. The study drug darolutamide, in combination with ADT and docetaxel is an approved treatment for another type of prostate cancer. To better understand the impact of this combination therapy on low-volume mHSPC and make better treatment choices, more knowledge is needed. ADT is a hormone therapy that lowers the level of testosterone, a male hormone, and slows down the growth of cancer cells. Darolutamide blocks androgen signals to slow the growth of the cancer cells. Docetaxel is a type of chemotherapy used to treat different types of cancer. It works by stopping the growth and spread of cancer cells. The prostate gland is a male reproductive gland found below the bladder. Low-volume mHSPC is a cancer of the prostate gland that has spread beyond the gland to three or fewer bones but has not reached organs like the lungs and liver. The prostate cancer is considered hormone sensitive when it responds to an anti hormonal therapy. In this study, only observations from routine clinical practices will be made. Participants will receive darolutamide, in combination with ADT and docetaxel as prescribed by their doctors during routine medical care. The participants will not receive any advice on treatment or any changes to healthcare as a part of the study. The main purpose of this study is to learn more about how safe darolutamide is and how well it works in combination with ADT and docetaxel in adult Japanese men with mHSPC in routine medical care. To do this, researchers will assess the following information about participants after one year of receiving the combination therapy by their doctors: • the number of participants who achieve normal levels of prostate specific antigen (PSA). PSA is a protein found in the blood that helps doctors monitor prostate cancer. • the number of participants who have adverse events (AEs), serious adverse events (SAEs), and adverse events of special Interest (AESIs) that lead to discontinuation or change in the dose of darolutamide or docetaxel during the study. AEs are medical problems that the participants had during the study that may or may not be related to the study treatment. SAEs are AEs that lead to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby to be born with medical problems, or is medically important. AESIs are specific medical problems the participants had during the study that may be related to heart, lung, liver etc. The data will come from the participant's medical records and will be collected between October 2024 and June 2031. Researchers will only look at the health records from adult men with mHSPC in Japan. No separate visits are required as part of the study. The participants will only visit their doctor at the study clinic as part of their routine medical care.
NCT06835218
The aim of this registry study with long-term follow-up is to record the course of therapy and disease in patients with recurrent and metastatic prostate cancer. The following patient groups are planned: * Patients with a recurrence of PSA after surgical removal or radiation of the prostate due to prostate cancer; so-called PSA recurrence (relapse) or biochemical recurrence. * Patients with a PSA recurrence who have received treatment by hormone deprivation therapy (so-called androgen deprivation) and in whom the PSA value has nevertheless risen again without spreading to other organs or parts of the body, so-called non-metastatic castration-resistant prostate cancer. * Patients with proven spread to other organs or parts of the body (= metastases, e.g. in the bone) without hormone deprivation therapy having been initiated, so-called metastatic hormone-sensitive prostate cancer. * Patients with prostate cancer and spread to other organs or parts of the body (= metastases) in whom the tumor disease has progressed despite hormone withdrawal treatment (e.g. as evidenced by an increase in PSA), so-called metastatic castration-refractory prostate cancer. These four groups of patients are enrolled and observed independently of each other at different time periods.
NCT07190300
The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
NCT06010914
This is an observational study in which only data are collected from participants receiving their usual treatment. In this study, data will be collected and studied from men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Metastatic means that the cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with hormone-therapy such as androgen deprivation therapy (ADT). ADT lowers the level of testosterone, a male hormone, and slows down the growth of cancer cells. Men with mHSPC and who have been decided by their own doctors to be treated with darolutamide in combination with ADT and docetaxel can join this study. Darolutamide works by blocking the testosterone signals to slow the growth of the cancer cells. Docetaxel is a medicine used to treat different types of cancer. It works by stopping the growth and spread of cancer cells. Darolutamide in combination with docetaxel and ADT is an approved treatment for men with mHSPC. It was approved based on a study called ARASENS. More information is needed on how safe darolutamide is when given with ADT and docetaxel in Japanese men with mHSPC. The main purpose of this study is to collect information about the safety of this combination treatment in Japanese participants with mHSPC under real-world conditions. The main information that researchers will collect: Number and severity of heart-related medical problems participants have during the treatment Other information that researchers will collect: Number and severity of all medical problems participants have during the study Age and other information about the participants such as their illness, medical history, and other medicines taken at the same time Treatment pattern of darolutamide such as the amount of medicine given, the duration for which it is given, and any changes made to the treatment Data will be collected from August 2023 to July 2026. Researchers will observe participants from the start of darolutamide treatment until 30 days after they receive their last dose of docetaxel, which is expected to be approximately 6 months for each participant. In this study, data from regular health visits will be collected. No visits or tests are required as part of this study.
NCT07181122
This prospective observational study will evaluate quality of life, functional status, and cognitive outcomes in men with metastatic hormone-sensitive prostate cancer (mHSPC) receiving androgen receptor pathway inhibitors (ARPIs) in addition to standard androgen deprivation therapy. ARPIs in this study include abiraterone acetate, apalutamide, enzalutamide, and darolutamide, depending on local availability. A total of 102 patients will be enrolled from two academic oncology centers in Türkiye. Participants will be assessed at baseline, 3 months, and 6 months using validated Turkish versions of established questionnaires: Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Patient Health Questionnaire-9 (PHQ-9), and Pittsburgh Sleep Quality Index (PSQI). Clinical parameters, ECOG performance status, routine laboratory results, and treatment-related adverse events will also be recorded. The primary outcomes are longitudinal changes in FACT-Cog and FACT-F scores. Secondary outcomes include changes in depression, sleep quality, laboratory results, and adverse events. This study will provide real-world evidence on how ARPI therapy affects cognitive health and quality of life in patients with mHSPC.
NCT06479187
The goal of this clinical trial is to learn if serial PSMA-PET/CT scans can be used to monitor response to therapy in metastatic hormone sensitive prostate cancer and can be potentially used to optimize future treatment approaches. The main questions it aims to answer are: What is the proportion of men with residual PSMA-avid disease on PET/CT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer? Do the findings on PSMA-PET/CT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer correlate with other markers of disease status, like PSA? Participants will: Receive standard of care treatment for metastatic hormone sensitive prostate cancer Undergo a PSMA-PET/CT scan before starting treatment Undergo a PSMA-PET/CT scan after 6 months of treatment Have a chart review every 3 months for 1 year after the 6 month PSMA-PET/CT scan