[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-metastatic-castration-resistant-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-metastatic-castration-resistant-prostate-cancer":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,39,61,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100634373","an-observational-study-conducted-in-china-to-evaluate-the-efficacy-and-safety-of-darolutamide-in-combination-with-androgen-deprivation-therapy-adt-for-men-with-non-metastatic-prostate-cancer-that-progressed-following-prior-bicalutamide--adt-treatment-100634373",false,"NCT07538843","An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment","A Multicenter, Real-world Study Evaluating the Effectiveness of Darolutamide Plus ADT in Patients Progressing to nmCRPC After Bicalutamide Plus ADT Treatment During nmHSPC Stage","DARE","Inclusion Criteria:\n\n* Males Age ≥ 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Patients receiving ≥6 m ADT+Bicalutamide in nmHSPC, progressed to nmCRPC judged by investigators.\n* Serum testosterone level\\\u003C1.7 nmol\u002FL.\n* Decision to initiate treatment with ADT + Darolutamide as per investigator's routine treatment practice.\n* No evidence of metastasis as assessed by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) for soft tissue disease and whole-body radionuclide bone scan for bone disease.\n* The informed consent form must be signed by the patient or his legal guardian (as applicable).\n* Patients who are fertile must use an effective method of contraception during the study and must refrain from donating sperm during the study or for 3 months after the end of treatment, unless they have undergone a radical prostatectomy.\n\nExclusion Criteria:\n\n* Participation in an investigational program with interventions outside of routine clinical practice.\n* Presence of distant metastases, including involvement of the Central Nervous System (CNS) and vertebral or meningeal involvement.\n* Symptomatic local or regional lesions requiring medical intervention (moderate or severe urinary tract obstruction or hydronephrosis caused by the primary tumor).\n* Previous treatment with 2nd-generation ARIs.\n* Previous treatment with CYP17 inhibitors.\n* Previous treatment with radiopharmaceuticals, immunotherapy, or other investigational treatment for nmCRPC.\n* Severe\u002Funstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias.\n* Gastrointestinal diseases affecting absorption.","MALE","18 Years",{"count":20,"type":21},800,"ESTIMATED","OBSERVATIONAL","In this observational study, participants receive darolutamide: a treatment that is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC).\n\nProstate cancer is a common cancer in men, and the number of cases is rising, especially in China. Many men are diagnosed at a late stage, which makes treatment more difficult. Standard treatment for prostate cancer often includes lowering the levels of male hormones (androgens) in the body, as these hormones can help the cancer grow. This is called androgen deprivation therapy (ADT). Sometimes, medicines like bicalutamide are added to ADT, but over time, the cancer can become resistant to these treatments. When this happens and the cancer has not yet spread to other parts of the body, it is called nmCRPC. Newer agents, such as darolutamide, have demonstrated efficacy in controlling the disease and delaying progression, with a more favorable safety profile and fewer severe adverse events than conventional therapies.\n\nThis study wants to observe how effective darolutamide plus ADT is at controlling the cancer in Chinese men with nmCRPC who have already been treated with bicalutamide plus ADT during an earlier stage of their disease, known as non-metastatic hormone-sensitive prostate cancer (nmHSPC), but whose cancer has since progressed despite that treatment.\n\nThe study will look at how many participants have their prostate-specific antigen (PSA) levels drop to undetectable levels within 6 months of starting darolutamide (in the main group of 800 participants). PSA is a protein made by the prostate, and high levels can be a sign of prostate cancer. In a smaller group of 100 participants, the study will also look at how many men remain free from PSA progression (a sign that the cancer is not getting worse) after 12 months.\n\nTo learn more about the safety of darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.",[25],"Non-metastatic Castration-resistant Prostate Cancer","NOT_YET_RECRUITING","2026-06-26",{"date":29,"type":30},"2026-06-29","ACTUAL",{"date":32,"type":21},"2026-07-30",{"date":34,"type":21},"2030-01-30",{"name":36,"class":37},"Bayer","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":38},"100541765","an-observational-study-to-learn-more-about-the-safety-of-darolutamide-in-men-with-prostate-cancer-in-korea-100541765","NCT06334120","An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea","Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients","Inclusion Criteria:\n\n* Male aged ≥19 years\n* Patients with high risk nmCPRC\n\n  * Castrate level of serum testosterone (\\\u003C 1.7 nmol\u002Fl \\[50 ng\u002FdL\\])\n  * PSA doubling time \\\u003C 10 months\n* Patients with mHSPC\n\n  * histologically or cytologically confirmed prostate cancer, and metastases detected on bone scanning, contrast-enhanced computed tomography (CT), or magnetic resonance imaging (MRI).\n  * be candidates for androgen-deprivation therapy with\u002Fwithout docetaxel.\n* Patients for whom the decision to initiate treatment with Darolutamide as a first time was made as per investigator's routine treatment practice\n* Written informed consent from subject or legal representative; assent from subject when appropriate\n\nExclusion Criteria:\n\n* Patients participating in an investigational program with interventions outside of routine clinical practice\n* Participants with contraindication according to the locally approved prescribing information","19 Years",{"count":48,"type":21},600,"This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.\n\nThis study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.\n\nTo learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.\n\nDuring this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.\n\nEach participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events.",[25,51],"Metastatic Hormone-sensitive Prostate Cancer","RECRUITING","2026-06-23",{"date":55,"type":30},"2026-06-24",{"date":57,"type":30},"2024-09-25",{"date":59,"type":21},"2028-06-30",{"name":36,"class":37},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":75,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100466065","phase-4-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-100466065","NCT05348876","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)","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)","Inclusion Criteria:\n\n* Capable of giving signed informed consent.\n* Participant must be male aged ≥ 18 years.\n* Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.\n* Castration resistance, demonstrated by:\n\n  * a minimum of 3 rising PSA values while the participant is on continuous ADT (started at least 4 weeks prior to the PSA measurement or, PSA measured at least 4 weeks after bilateral orchiectomy) and\n  * the interval between each PSA measurement must be ≥ 1 week, and\n  * the PSA value at screening must be ≥ 1.0 ng\u002FmL (1.0 μg\u002FL). To confirm this eligibility criterion, it is acceptable for 2 out of the 3 PSA measurements to be taken during the 28-day screening period (after participant has signed consent), provided the measurements are ≥ 1 week apart. In this case, the last PSA value should be recorded as the screening value.\n* Castrate level of serum testosterone (\\\u003C 1.7 nmol\u002FL \\[50 ng\u002FdL\\]) on gonadotropin releasing hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy. Participants who have not undergone bilateral orchiectomy must continue GnRH therapy during the study.\n* PSA doubling time (PSADT) of ≤ 10 months.\n* Eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1.\n* Estimated glomerular filtration rate (eGFR) \\> 15 mL\u002Fmin\u002F1.73 m\\^2.\n* Blood counts at screening: hemoglobin ≥ 9.0 g\u002FdL, absolute neutrophil count ≥ 1500\u002FμL (1.5 × 109\u002FL), platelet count ≥ 100,000\u002FμL (100 ×109\u002FL) (participant must not have received any growth factor or blood transfusion within 7 days of the hematology laboratory obtained at screening).\n* Screening values of serum alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit of normal (ULN), total bilirubin (TBL) ≤ 1.5 × ULN (except participants with a diagnosis of Gilbert's disease), creatinine ≤ 2.0 × ULN.\n* Sexually active participants, unless surgically sterile, must agree to use a male condom plus partner use of a contraceptive method with a failure rate of \\\u003C1% per year, and refrain from sperm donation during the study treatment and for 1 week after the last dose of study treatment. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* History of metastatic disease at any time or presence of detectable metastases by investigator assessment within 42 days prior to start of study treatment based on standard medical imaging, i.e., computed tomography\u002F magnetic resonance imaging (CT\u002FMRI) and bone scan. (Lesions seen on prostate-specific membrane antigen \u002Fpositron emission tomography (PSMA\u002FPET) scan that are not detected on standard imaging do not exclude participation.) Presence of pelvic lymph nodes \\\u003C 1.5 cm in short axis below the aortic bifurcation is allowed.\n* Symptomatic local-regional disease that requires medical intervention including moderate\u002Fsevere urinary obstruction or hydronephrosis due to prostate cancer.\n* Acute toxicities of prior treatments and procedures not resolved to common terminology criteria for adverse events (CTCAE) v.5.0 grade ≤ 1 or baseline before first dose of study treatment.\n* Severe or uncontrolled concurrent disease, infection, or co-morbidity that, in the opinion of the investigator, would make the participant inappropriate for enrollment.\n* Known hypersensitivity to the study treatment or any of its ingredients.\n* Major surgery within 28 days before first dose of study treatment.\n* Any of the following within 6 months before first dose of study treatment: stroke, myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft; congestive heart failure New York Heart Association Class III or IV.\n* Uncontrolled hypertension as indicated by a systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg at screening despite medical management. Participants with hypertension can enroll provided BP is stable and controlled by anti-hypertensive treatment.\n* End-stage renal disease (eGFR \\\u003C 15 mL\u002Fmin\u002F1.73 m\\^2).\n* Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed ≥ 5 years ago and from which the participant has been disease-free.\n* Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.\n* Unstable active viral hepatitis with a need for treatment.\n* Known human immunodeficiency virus (HIV) infection with any of the following (Note: HIV testing is not required unless mandated by local authority):\n\n  * CD4+ T-cell (CD4+) count of less than 350 cells\u002FμL\n  * History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months\n  * On established antiretroviral therapy for less than 4 weeks\n  * Presenting with a viral load of more than 400 copies\u002FmL prior to enrollment\n  * On antiretroviral therapy or prophylactic antimicrobials that are expected to cause significant drug-drug interactions or overlapping toxicities with study treatment and cannot be changed to alternative agents.\n* Any condition that, in the opinion of the investigator, would impair the participants' ability to comply with the study procedures or study treatment (e.g., unable to swallow study treatment).\n* Unwilling or unable to comply with all protocol-required visits and assessments or comply with study requirements.\n* Prior treatment with:\n\n  * Second-generation androgen receptor (AR) inhibitors (such as enzalutamide, apalutamide, darolutamide, proxalutamide, etc)\n  * Other investigational AR inhibitors\n  * Cytochrome P450 (CYP17) enzyme inhibitors (such as oral ketoconazole, abiraterone acetate, TAK-700, etc).\n* Use of first-generation AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate) within 28 days before first dose of study treatment.\n* Use of estrogens or 5-α reductase inhibitors (finasteride, dutasteride) within 28 days before first dose of study treatment.\n* Prior chemotherapy or immunotherapy for prostate cancer, except adjuvant\u002Fneoadjuvant treatment completed \\> 2 years before first dose of study treatment.\n* Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone\u002Fday within 28 days before first dose of study treatment.\n* Radiation therapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 12 weeks before first dose of study treatment.\n* Treatment with an osteoclast-targeted therapy (bisphosphonate or denosumab) to prevent skeletal-related events within 4 weeks before first dose of study treatment. Participants receiving osteoclast-targeted therapy to prevent bone loss at a dose and schedule indicated for osteoporosis may continue treatment at the same dose and schedule.\n* Treatment with any investigational drug within 28 days before first dose of study treatment.",{"count":69,"type":21},50,"INTERVENTIONAL",[72],"PHASE4","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.\n\nIn men with nmCRPC, the cancer worsens despite low testosterone levels (also called castration resistant).\n\nProstate-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.\n\nMen 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.\n\nThe 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.\n\nResults 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.\n\nTherefore, 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.\n\nTo 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:\n\n* the number and severity of AEs that are non-serious or serious\n* the number of participants who have to permanently stop the treatment due to AEs\n* the number of participants who have to change the amount of study drug taken due to AEs\n\nAEs can be:\n\n* 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).\n* relevant changes in vital signs\n* relevant changes of the participant's daily living abilities (ECOG performance status)\n\nThese results will then be compared with the results from the previous study to identify any differences for this group of participants.\n\nIn addition, researchers will collect and compare data on how well darolutamide worked under real world conditions in this group of participants.\n\nAll 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.\n\nDuring the study, the study team will\n\n* take blood and urine samples\n* do physical examinations\n* check vital signs\n* examine heart health using ECG\n* assess the participant's ECOG performance status\n* ask the participants questions about how they are feeling and what AEs they are having.\n\nIf the trial is stopped, participants may have the option to continue to receive darolutamide, provided they benefit from the treatment",[25],[76],"Prostate cancer","2026-06-12",{"date":79,"type":30},"2026-06-15",{"date":81,"type":30},"2022-08-03",{"date":83,"type":21},"2027-04-29",{"name":36,"class":37},25,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100580278","procare---prostate-cancer-real-world-evidence-registry-100580278","NCT06835218","PROCARE - PROstate Cancer Real World Evidence Registry","PROstate CAncer Real World Evidence Registry: RECURRENT AND METASTATIC PROSTATE CANCER","PROCARE","Inclusion Criteria:\n\n* Adult prostate cancer patients (age ≥18 years).\n* Diagnosis at time of study inclusion Cohort 1: biochemical recurrence (BCR) after local curative intended treatment (e.g. radical prostatectomy, radiotherapy of the prostate or combination thereof) Cohort 2: non-metastatic castration-resistant prostate cancer (nmCRPC) or Cohort 3: metastatic hormone sensitive prostate cancer (mHSPC) or Cohort 4: metastatic castration-resistant prostate cancer (mCRPC) (irrespective of treatment choice, treatment line)\n* Patients who will receive a new line of systemic therapy at the time of study entry or up to 4 weeks thereafter. Regarding Cohort 4 this includes patients with a new diagnosis of mCRPC (=first line mCRPC) after either treatment for mHSPC or non-metastatic CRPC as well as patients with prior mCRPC treatments (2nd, 3rd, … line).\n* For Cohorts 1, 2 and 3: Disease proven by clinical measures (i.e. standard imaging) to be either unsuitable for local salvage treatment (e.g. surgery, radiotherapy) or local treatment is declined by the patient.\n* Patients, who are able and willing to sign the informed consent form\n\nExclusion Criteria:\n\n• Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician",{"count":95,"type":21},5000,"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:\n\n* 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.\n* 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.\n* 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.\n* 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.\n\nThese four groups of patients are enrolled and observed independently of each other at different time periods.",[98,99,25,100,101],"Prostate Cancer","Biochemical Recurrence of Malignant Neoplasm of Prostate","Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Metastatic Castration-resistant Prostate Cancer",[103],"prostate, cancer, metastatic, systemic therapy","2026-03-10",{"date":106,"type":30},"2026-03-12",{"date":108,"type":30},"2024-01-29",{"date":110,"type":21},"2032-12-31",{"name":112,"class":113},"UroTrials Company (GmbH)","NETWORK",53]