[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biochemical-recurrence-of-malignant-neoplasm-of-prostate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biochemical-recurrence-of-malignant-neoplasm-of-prostate":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,59,88,118,145],{"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":33,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100630129","non-inferiority-study-comparing-salvage-pelvic-radiotherapy-in-25-fractions-625-gy25-versus-20-fractions-525-gy20-for-recurrent-prostate-cancer-after-surgery-100630129",false,"NCT07483658","Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy\u002F25) Versus 20 Fractions (52.5 Gy\u002F20) for Recurrent Prostate Cancer After Surgery.","Non-Inferiority Study Comparing Hypofractionated Post-Operative Salvage Radiotherapy Regimens: 45\u002F62.5 Gy in 25 Fractions vs. 43\u002F52.5 Gy in 20 Fractions for Grade 2+ GU or GI Toxicity (HYP-OP-RT)","HYP-OP-RT","Inclusion Criteria:\n\n* Histologically confirmed prostate adenocarcinoma.\n* Prior radical prostatectomy with detectable PSA (≥0.2 ng\u002FmL).\n* No evidence of distant metastasis (confirmed via bone scan and CT\u002FMRI or TEP-PSMA if PSA is above 0.5 ng \u002Fml).\n* Patient with Nodal recurrence within the pelvis are eligible\n* ECOG performance status 0-2.\n* Age ≥ 18 years.\n* Adequate baseline renal, hepatic, and hematologic function.\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy.\n* Macroscopic local relapse on imaging\n* Presence of metastatic disease.\n* Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.\n* Uncontrolled comorbidities affecting study participation.\n* Prior systemic therapy for recurrent prostate cancer (except ADT within 6 months).","MALE","18 Years",{"count":20,"type":21},434,"ESTIMATED","INTERVENTIONAL",[24],"NA","Study Overview This research compares two types of post-operative salvage radiotherapy (SRT) for men with prostate cancer who have had surgery but show signs of recurrence (detectable PSA). The goal is to see if a shorter treatment schedule is as safe and effective as the standard schedule.\n\nWhy is this study important? After prostate surgery, cancer can return in up to 70-80% of high-risk patients. Radiotherapy helps control this, but the best way to deliver it-especially the number of sessions and whether to treat the pelvic area-is still being studied. Shorter treatments could mean less time in therapy and better quality of life, if such treatments are proven safe.\n\nWhat is being compared?\n\nStandard treatment (Arm A):\n\n25 sessions (about 5 weeks) Prostate bed: 62.5 Gy Pelvis: 45 Gy\n\nShorter treatment (Arm B):\n\n20 sessions (about 4 weeks) Prostate bed: 52.5 Gy Pelvis: 43 Gy\n\nBoth groups may also receive hormone therapy (ADT) for 6-24 months.\n\nMain Goal To check if the shorter treatment causes no more side effects (urinary or bowel problems) than the standard treatment, while keeping cancer control similar.\n\nOther Things to be Measured\n\nCancer control (PSA levels, spread of disease) Survival Quality of life (urinary, bowel, sexual health questionnaires)\n\nWho can join?\n\nMen who:\n\nHad prostate surgery Have a detectable PSA (≥0.2 ng\u002FmL) No distant metastasis Are in good general health (ECOG 0-2)\n\nHow long will the study last?\n\nAbout 12 years total:\n\n2 years to enroll patients 10 years of follow-up",[27,28,29,30,31,32],"Reccurent\u002FMetastatic Solid Tumor Disease","Prostate Cancer (Post Prostatectomy)","Prostate Cancer","Prostatic Neoplasms","Neoplasm Recurrence, Local","Biochemical Recurrence of Malignant Neoplasm of Prostate",[34,35,36,37,38,39,40,41,42,43,44,45],"Radiotherapy, Adjuvant","Radiotherapy, Intensity-Modulated","Radiotherapy, High-Dose Hypofractionated","Pelvic Radiotherapy","Androgen Deprivation Therapy","Randomized Controlled Trials","Noninferiority Trials","Quality of Life","Treatment Outcome","Gastrointestinal Diseases \u002F chemically induced","Urinary Tract Diseases \u002F chemically induced","Radiation Injuries","RECRUITING","2026-06-29",{"date":49,"type":50},"2026-07-01","ACTUAL",{"date":52,"type":50},"2026-05-13",{"date":54,"type":21},"2036-02",{"name":56,"class":57},"CHU de Quebec-Universite Laval","OTHER",4,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"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":68,"type":21},5000,"OBSERVATIONAL","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.",[29,32,72,73,74],"Non-metastatic Castration-resistant Prostate Cancer","Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Metastatic Castration-resistant Prostate Cancer",[76],"prostate, cancer, metastatic, systemic therapy","2026-03-10",{"date":79,"type":50},"2026-03-12",{"date":81,"type":50},"2024-01-29",{"date":83,"type":21},"2032-12-31",{"name":85,"class":86},"UroTrials Company (GmbH)","NETWORK",53,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100582122","a-prospective-bicentric-evaluation-of-fluciclovine-pet-imaging-in-patients-with-prior-negative-or-inconclusive-psma-ligand-pet-100582122","NCT06859203","A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET","Prospective Evaluation of Fluciclovine (18F) PET\u002FCT in Patients with Prior Negative PSMA PET\u002FCT","REFINE","Inclusion Criteria:\n\n* Patient is male and aged \\>18 years old.\n* Patient with a history of localized adenocarcinoma of the prostate with prior curative intent treatment, experiencing BCR of hormone sensitive PCa, following prior treatment with one or more of the following: a) RP, b) RP plus adjuvant therapy, c) RT and\u002For androgen deprivation therapy \\[ADT\\].\n* An elevated PSA, clinically suspicious for biochemically recurrent disease, that meets one of the following conditions: 1) Following RP with or without adjuvant therapy: PSA ≥0.2 ng\u002FmL followed by a subsequent confirmatory PSA value ≥0.2 ng\u002FmL and within the total range of 0.2 and 2 ng\u002Fml. PSA must be measured at least 6 weeks after RP. 2) Following RT (e.g. radical radiotherapy or brachytherapy) as the primary treatment: nadir +2 ng\u002FmL and within the total range of 2 and 4 ng\u002Fml\n\nExclusion Criteria:\n\n* Patients with any medical condition or circumstance (including receiving an investigational product) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.\n* Current or recent androgen deprivation therapy (ADT) within 3 months prior to the start of the study, which includes surgical orchidectomy, continuous or intermittent LHRH agonist\u002Fantagonist, and first-\u002Fsecond-generation anti androgen alone or combined with LHRH agonist\u002Fantagonist.",{"count":97,"type":21},94,"The REFINE study is evaluating whether a fluciclovine (18F) PET\u002FCT scan can detect recurrent prostate cancer in patients whose previous PSMA PET\u002FCT was negative or inconclusive.",[32],[101,102,103,104,105,106,107],"prostate cancer","biochemical recurrence","PET","PSMA","fluciclovine","BCR","prostate","2025-02-27",{"date":110,"type":50},"2025-03-05",{"date":112,"type":21},"2025-03",{"date":114,"type":21},"2027-12",{"name":116,"class":57},"Technical University of Munich",2,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100566588","diagnostic-performance-of-18fpsma-1007-in-the-context-of-biochemical-recurrence-of-prostate-cancer-100566588","NCT06657131","Diagnostic Performance of [18F]PSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer","Diagnostic Performance and Clinical Impact of [18F]PSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer: a Real-World Evidence from a Monocentric, Prospective Observational Phase-4-Trial","[18F]PSMA-1007","Inclusion Criteria:\n\n* Informed Consent\n* Conduct of \\[18F\\]PSMA-1007 PET Imaging in the context of regular clinical care\n\nExclusion Criteria:\n\n* Technical Flaws in the acquisition protocol",{"count":127,"type":21},250,"Following numerous retrospective studies and Phase-3-Studies with promising results, \\[18F\\]PSMA-1007 has been approved by european authorities. Therefore, it is a growing deployment of this diagnostic method anticipated. This study aims to investigate the diagnostic performance and clinical impact in a real-world-evidence in the context of regular clinical care. The evidence generated by this approach is supposed to assist in optimizing the management of prostate cancer patients.",[130,32,131],"Prostate Cancer After a Radical Treatment","Biochemical Persistence of Prostate Cancer",[101,102,133,124,134],"18F-PSMA-1007","biochemical persistence","2025-01-16",{"date":137,"type":50},"2025-01-17",{"date":139,"type":50},"2024-11-01",{"date":141,"type":21},"2028-11-30",{"name":143,"class":57},"Heinrich-Heine University, Duesseldorf",1,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":169},"100504364","phase-3-68ga-psma-11-efficacy-in-detecting-bcr-prostate-cancer-in-chinese-patients-100504364","NCT05847348","68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients","A Prospective, Open-Label, Single-Arm, Multi-center Study to Evaluate the Diagnostic Efficacy and Safety of 68Ga-PSMA-11 PET\u002FCT or PET\u002FMRI in Patients With Biochemical Recurrent Prostate Cancer","Inclusion Criteria:\n\n1. Are able to understand and provide written informed consent document.\n2. Are Chinese males aged ≥ 18 years.\n3. Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and\u002For radical radiotherapy and experienced biochemical recurrence (PSA should be measured within 30 days of screening).\n\n   1. Post radical prostatectomy (RP) PSA ≥0.2 ng\u002FmL measured 6 weeks after RP\n   2. Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng\u002FmL rise in PSA;\n4. Have a Karnofsky performance status ≥ 60 (or ECOG\u002FWHO equivalent).\n5. Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.\n6. Are willing and able to comply with scheduled\n\nExclusion Criteria:\n\n1. Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.\n2. Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.\n3. Are participating or plan to participate in any drug or device clinical study during the study period.\n4. Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.\n5. Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.\n6. Have prior history of salivary gland disease or Paget's disease.\n7. Have a history of fracture and anemia within the last year.\n8. Have abnormalities in physical examination, ECG, and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance.\n9. Is deemed not suitable for participating in this trial in the opinion of the investigator.",{"count":153,"type":21},110,[155],"PHASE3","This is a prospective, open-label, single-arm, multicenter bridging study in Chinese patients with prostate cancer. This multicenter study is planned to be conducted in patients with biochemical recurrence (BCR) of elevated PSA after radical prostatectomy or radical radiotherapy. This study investigates how well 68Ga-PSMA-11 PET\u002FCT works in detecting BCR prostate cancer in Chinese patient. 68Ga-PSMA-11, developed by Telix, is a new molecular entity tracer with the trade name Illuccix®, which is approved by FDA for the examination of: 1) patients with suspected metastatic PC who are scheduled for initial treatment; 2) patients with biochemical recurrence of elevated PSA levels after initial radical radiotherapy.",[32,29,158],"BCR Prostate Carcinoma","2024-06-29",{"date":161,"type":50},"2024-07-03",{"date":163,"type":50},"2023-07-19",{"date":165,"type":21},"2026-07-30",{"name":167,"class":168},"Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY",8]