[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer-patients-undergoing-radical-prostatectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer-patients-undergoing-radical-prostatectomy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,69,98],{"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":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100622737","phase-2-psma-targeted-intraoperative-fluorescent-imaging-agents-dgpr1008-validation-across-different-time-windows-100622737",false,"NCT07387510","PSMA-Targeted Intraoperative Fluorescent Imaging Agents (DGPR1008): Validation Across Different Time Windows","A Phase Ⅱ, Single-arm, Open-label Trial of DGPR1008 for Intraoperative Fluorescence Imaging of Prostate-specific Membrane Antigen-positive Prostate Cancer","DGPR1008-04","Inclusion Criteria:\n\n1. Subjects diagnosed with prostate cancer through preoperative transrectal prostate biopsy and pathological examination, who are scheduled to undergo radical prostatectomy with or without pelvic lymph node dissection;\n2. Subjects must provide informed consent prior to trial initiation, fully understand the trial content, procedures, and potential adverse reactions, be capable of effective communication with the investigator, and be able to complete the trial as per protocol requirements. They must voluntarily sign a written informed consent form;\n3. Adult male subjects aged 18 years or older (including the boundary value);\n4. Gleason score ≥7, or imaging studies (transrectal ultrasound \\[TRUS\\] and\u002For prostate magnetic resonance imaging \\[MRI\\] or CT or PSMA PET\u002FCT) demonstrating disease staging ≥T2, or imaging evidence of regional lymph node enlargement suggestive of lymph node metastasis;\n5. No hepatic or renal impairment: Hepatic: Total bilirubin ≤ 2 times the upper limit of normal (ULN) (excluding Gilbert syndrome), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3×ULN; Renal: Creatinine clearance ≥ 50 mL\u002Fmin\u002F1.73 m² (simplified MDRD formula);\n6. The investigator determines the subject has no clear contraindications for surgery and is suitable for radical prostatectomy;\n7. The subject and their partner or spouse must agree to have no plans for pregnancy or sperm donation from the screening period until 3 months after trial completion, and voluntarily use effective contraception.\n\nExclusion Criteria:\n\nSubjects will be excluded if they meet any one of the following criteria:\n\n1. Subjects with a history of allergies (e.g., known allergies to two or more medications), those prone to allergic reactions such as rashes or hives, or those with known allergies to the investigational drug (including its formulation components);\n2. Subjects with significantly abnormal screening test results deemed clinically significant by the investigator and likely to affect study participation; or those with concomitant conditions posing serious safety risks or impeding study completion (except where the investigator determines the condition is stable and allows enrollment);\n3. Subjects who participated in another clinical trial involving investigational drugs or devices within the month preceding study drug administration;\n4. Subjects who have undergone neoadjuvant therapy, radiation therapy, focal ablation therapy, hormone therapy, or androgen deprivation therapy within the past 6 months;\n5. Subjects deemed by the investigator to have other conditions rendering them unsuitable for participation in this trial.","MALE","18 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","a Phase II, single-arm, open-label, multi-center study to evaluate safety, tolerability, pharmacokinetics, and the effectiveness of near-infrared fluorescence imaging during surgery.",[27],"Prostate Cancer Patients Undergoing Radical Prostatectomy","NOT_YET_RECRUITING","2026-01-28",{"date":31,"type":32},"2026-02-04","ACTUAL",{"date":34,"type":21},"2026-02-27",{"date":36,"type":21},"2026-09-27",{"name":38,"class":39},"Haitao Niu, MD","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100616698","limited-versus-extended-lymph-node-dissection-during-radical-prostatectomy-in-patients-with-localized-or-locally-advanced-prostate-cancer-100616698","NCT07308990","Limited Versus Extended Lymph Node Dissection During Radical Prostatectomy in Patients With Localized or Locally Advanced Prostate Cancer","To Develop and Implement a Method for Optimizing the Volume of Lymph Node Dissection in Radical Surgical Treatment of Localized or Locally Advanced Prostate Cancer","Inclusion Criteria:\n\n1. Age over 18 years.\n2. Histologically confirmed localized or locally advanced prostate cancer (adenocarcinoma without a neuroendocrine component).\n3. No evidence of metastatic spread of the tumor\n4. Local resectability of the tumor according to digital rectal examination and\u002For CT and\u002For MRI of the pelvis\n5. Patients are suitable for radical prostatectomy based on their comorbidities and life expectancy.\n6. Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Presence of another active malignant invasive neoplasm.\n2. Contraindication to pelvic lymph node dissection (e.g., history of radiation therapy to the pelvis).\n3. The evidence of metastases in regional lymph nodes according to preoperative examination data (including PET\u002FCT with PSMA).\n4. Severe concomitant disease limiting participation in the study.",{"count":49,"type":21},800,[51],"NA","This is a randomized controlled study assessing outcome of low (no or limited) versus high (limited or extended) extent of lymph node dissection in addition to radical prostatectomy in patients with operable localized or locally advanced prostate cancer.",[27],[55,56,57],"prostate cancer","lymph node dissection","radical prostatectomy","RECRUITING","2025-12-15",{"date":61,"type":32},"2025-12-30",{"date":63,"type":32},"2025-10-29",{"date":65,"type":21},"2032-05-30",{"name":67,"class":68},"N.N. Alexandrov National Cancer Centre","OTHER_GOV",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":40},"100611685","ejaculatory-behavior-and-seminal-vesicle-size-during-radical-prostatectomy-100611685","NCT07243795","Ejaculatory Behavior and Seminal Vesicle Size During Radical Prostatectomy","Impact of Preoperative Ejaculation or Abstinence on Seminal Vesicle Size and Intraoperative Dissection Parameters During Radical Prostatectomy: A Randomized Controlled Trial","PreRP-EJAC","Inclusion Criteria:\n\n* Male patients aged 18 years or older\n* Histologically confirmed prostate cancer\n* Scheduled for radical prostatectomy\n* Able and willing to comply with assigned ejaculation or abstinence protocol\n* Willing to complete preoperative questionnaire\n* Willing to undergo transrectal ultrasound (TRUS) 12-14 hours before surgery\n* Able to understand and sign informed consent\n\nExclusion Criteria:\n\n* Prior bilateral seminal vesicle resection or congenital absence of seminal vesicles\n* Anatomical abnormalities preventing SV identification\n* Hormone therapy within 6 months before surgery\n* Inability to recall ejaculation history in the past 3 days\n* Inability to follow behavioral instructions or TRUS protocol\n* Severe anorectal disease or history of anorectal surgery preventing TRUS\n* Cognitive or psychiatric conditions impairing informed consent\n* Incomplete data or poor-quality imaging\n* Prior prostate cancer treatment\n* Belonging to a vulnerable population (e.g., minors, prisoners, pregnant individuals, cognitively impaired, etc.)",{"count":78,"type":21},40,[51],"The goal of this clinical trial is to learn if recent ejaculation or abstinence before surgery affects seminal vesicle size and dissection-related surgical factors in adult men with prostate cancer undergoing radical prostatectomy. The main questions it aims to answer are:\n\nDoes ejaculation within 36 hours before surgery reduce seminal vesicle size compared to abstinence of 72 hours or more?\n\nDoes seminal vesicle size affect the ease or difficulty of surgical dissection during radical prostatectomy?\n\nResearchers will compare an ejaculation group to an abstinence group to see if seminal vesicle volume and intraoperative surgical parameters differ between them.\n\nParticipants will:\n\nFollow specific instructions to either ejaculate or abstain before surgery\n\nUndergo a transrectal ultrasound (TRUS) to measure seminal vesicle size after anesthesia but before surgery\n\nHave their surgical dissection time and difficulty rated by the operating surgeon",[27],[83,84,85,86,87,88],"Prostate Cancer","Radical Prostatectomy","Seminal Vesicle","Ejaculation","Abstinence","Surgical Dissection","2025-11-25",{"date":91,"type":32},"2025-12-03",{"date":93,"type":21},"2025-12-01",{"date":95,"type":21},"2026-10-09",{"name":97,"class":39},"National Taiwan University Hospital",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":115,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":129},"100565015","phase-2-fk-pc101-as-adjuvant-therapy-for-men-with-high-risk-prostate-cancer-100565015","NCT06636682","FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer","A Multicenter, Adaptive, Phase 2, Randomized, Open-label Study of Irradiated Autologous Cellular Vaccine in Men With High-Risk Prostate Cancer Following Prostatectomy","Inclusion Criteria:\n\n* Has localized high-risk or very high-risk prostate cancer based on the NCCN v4.2023 classification.\n* Has ≥3 prostate biopsy cores with ≥50% tumor involvement.\n* Has PSA \\>4 ng\u002FmL ≤28 days prior to enrollment.\n* Has no evidence of distant metastases based on PSMA-PET\u002FCT performed ≤28 days prior to enrollment.\n* Is a candidate for radical prostatectomy, and scheduled radical prostatectomy date must be 3 to 14 days after enrollment.\n* Has not received nor plans to receive neoadjuvant (preoperative) radiation therapy, androgen deprivation therapy (ADT), or any other anticancer therapy.\n* Has a life expectancy \\>5 years.\n\nAdditional key eligibility criteria immediately postoperative for inclusion in the randomized population include:\n\n* Stage \\>pT3a (tumor has extended outside of the prostate on one side).\n* Gleason score of 8, 9, or 10 (high\u002Fvery high) on prostatectomy specimen.\n* Subjects with pT3b or pT4 tumors with a Gleason sum 7 (4+3) are eligible.\n* Pelvic lymph node dissection (PLND) is required with either pN0 or pN1 nodal staging permitted.\n* Subjects must have negative surgical margins or microscopic-only positive surgical margins.\n\nFinal eligibility criteria at 2 months postoperative for randomization include:\n\n* FK-PC101 has been produced for the subject and meets all release specifications.\n* An undetectable PSA (\\\u003C0.04 ng\u002FmL) on the most recent test performed prior to randomization (Day -4 to -7).\n* No prior, current, or planned future postoperative or adjuvant XRT, hormonal therapy such as ADT, or any other anticancer therapy (future therapy should not be administered until evidence exists of prostate cancer disease recurrence \\[such as PSA recurrence\\]).\n* Adequate organ function based on CBC and chemistry studies within 2 weeks of Day 1 (Day -14 to -7). Specific laboratory requirements include:\n\n  * Absolute neutrophil count (ANC) \\>1000\u002FµL\n  * Platelet count \\>100,000\u002FµL.\n  * Hemoglobin \\>8.0 gm\u002FdL.\n  * Estimated glomerular filtration rate (eGFR) \\>60 mL\u002Fminute based on Cockcroft-Gault formula.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both \\\u003C2 × upper limit of normal (ULN).\n  * Albumin \\>3.0 gm\u002FdL.\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions of the study.\n\nExclusion Criteria:\n\n* Has an additional active malignancy that may confound the assessment of the study endpoints. If the subject has a past cancer history (active malignancy within 2 years prior to study entry) with substantial potential for recurrence, this must be discussed with the Sponsor before study entry. Note: Subjects with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer and carcinomas in situ (including breast DCIS, transitional cell carcinoma\u002FNMIBC, anal carcinoma, and melanoma in situ).\n* Is eligible for and elects to receive adjuvant therapy following RP.\n* Has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association \\[NYHA\\] Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, pulmonary embolism or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrhythmias not controlled by medication).\n* Has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the subject at significant risk for pulmonary complications during the study.\n* Has known metastases, such as bone, visceral, or brain or leptomeningeal metastases.\n* Has an active autoimmune disease or Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) or treatment with drugs (e.g., neomercazol, carbamazole) that function to decrease the generation of thyroid hormone by a hyperfunctioning thyroid gland (e.g., in Graves' disease) is not considered a form of systemic treatment of an autoimmune disease.\n* Is currently receiving systemic steroid therapy at a prednisone equivalent dose of \\>10 mg daily for at least 1 week or other form of immunosuppressive therapy within 7 days prior to enrollment.\n* Has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Is at risk for disseminated BCG infection or has previously demonstrated an allergic response to BCG or its components.\n* Has known positive status for human immunodeficiency virus (HIV) or active or chronic Hepatitis (Hep) B or Hep C. Screening is not required.\n* Has any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicity.",{"count":106,"type":21},100,[24],"The goal of this clinical trial is to learn if the vaccine FK-PC101 works to delay or prevent the return of prostate cancer in men who have had surgery to remove their prostate cancer. It will also learn about the safety of FK-PC101. The main questions it aims to answer are:\n\nDoes FK-PC101 delay or prevent the return of prostate cancer following surgery? What medical problems do participants (subjects) have when taking FK-PC101?\n\nResearchers will compare FK-PC101 to current treatment practice to see if FK-PC101 works to prevent or delay the return of prostate cancer following surgery to remove the prostate cancer tumor.\n\nSubjects will:\n\nHave a sample of the prostate cancer tissue collected at the time of surgery to remove this tissue from the body. This tissue will then be used to create a personalized vaccine that is specific to your prostate cancer.\n\nIf randomly selected to receive the vaccine, subjects will receive the vaccine up to 7 times over a 6-month period.\n\nIn addition to the treatment visits for those randomized to receive FK-PC101, there will be up to 4 follow up visits to the clinic over a 22-month (nearly 2 year) period.\n\nFor subjects randomized to receive current treatment practice, they will be asked to attend up to 8 visits over 22 months to track if there is any detectable cancer. Should their prostate cancer return within a year following surgery, they will be eligible to receive FK-PC101, which already had been produced and thus no additional tumor tissue would need to be obtained.\n\nSubjects in both study arms will have regular blood tests and scans to test whether their prostate cancer has returned.",[110,111,112,113,83,27,114],"Prostate Cancer (Adenocarcinoma)","Prostate CA","Prostate Cancers","Prostate Cancer (Post Prostatectomy)","High-risk Prostate Cancer",[116,117,118,84],"Vaccine","Prostatectomy","Autologous","2024-10-17",{"date":121,"type":32},"2024-10-21",{"date":123,"type":32},"2024-10-14",{"date":125,"type":21},"2027-05-04",{"name":127,"class":128},"Cellvax Therapeutics Inc","INDUSTRY",3]