[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"German Oncology Center, Cyprus\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,68],{"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},"100636663","comparing-psma-petct-and-mri-rsi-for-finding-and-outlining-tumors-inside-the-prostate-in-men-with-newly-diagnosed-prostate-cancer-100636663",false,"NCT07568613","Comparing PSMA PET\u002FCT and MRI-RSI for Finding and Outlining Tumors Inside the Prostate in Men With Newly Diagnosed Prostate Cancer","Prospective Comparison of PSMA PET\u002FCT and MRI-RSI (Restriction Spectrum Imaging) for Intraprostatic Tumor Detection and Delineation in Primary Prostate Cancer Patients","PRIDE2-PC","Inclusion Criteria:\n\n* Newly diagnosed and histologically confirmed primary prostate cancer\n* NCCNv4.2024 risk groups: unfavorable intermediate risk, high-risk and very high-risk\n* Males, age ≥ 18 years\n* ECOG performance status 0-2\n* Estimated life expectancy ≥ 5 years\n* PSMA-PET\u002FCT-hybrid imaging performed \\\u003C3 months\n* MRI-targeted biopsy on PIRADs v2.1 lesion ≥3 performed \\\u003C6 months\n\nExclusion Criteria:\n\n* Contraindications for MRI imaging\n* No visible tumor on PSMA PET and mpMRI (defined by PIRADs v2.1 ≤2 lesion)\n* TUR-P of the prostate \\\u003C1 year ago\n* Initial PSA \\>100 ng\u002Fml\n* History of cancer (exception: localized skin tumours, tumours treated ≥5 years previously with curative intent and no evidence of recurrent disease)\n* Previous radiation therapy to the pelvis\n* ADT or ADT + other systemic therapy before inclusion","MALE","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","The detection and delineation of the intraprostatic tumor burden plays a crucial role in the personalized treatment of primary prostate cancer. The current gold standard multiparametric magnetic resonance imaging (mpMRI) is used to guide targeted prostate biopsies for initial diagnostic work up and for definitive focal dose-escalated radiotherapy in intermediate and high-risk prostate cancer patients.\n\nHowever, mpMRI might underestimate the tumor volume and manual gross tumor volume delineation based on mpMRI underlies significant interobserver variability. Thus, novel imaging modalities are warranted to increase the detection rate and\u002For decrease the interobserver variability during tumor delineation.\n\nThis study will prospectively compare two promising advanced medical imaging methods: MRI-RSI and PSMA PET with the current gold-standard mpMRI for tumor detection and delineation in primary prostate cancer patients.",[27],"Prostate Cancer","RECRUITING","2026-04-28",{"date":31,"type":32},"2026-05-06","ACTUAL",{"date":34,"type":32},"2025-08-18",{"date":36,"type":21},"2027-07-31",{"name":38,"class":39},"German Oncology Center, Cyprus","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":40},"100560845","phase-2-artificial-intelligence-to-personalize-prostate-cancer-treatment-the-hypoelect-trial-100560845","NCT06582446","Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)","Whole-pelvis Hypofractionated Radiotherapy Combined With Dose-escalation to the Prostate and Androgen Deprivation Therapy in Primary Localized, NCCN and MMAI High-risk Prostate Cancer - a Prospective, Single-arm, Phase II Study","HypoElect","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old)\n* Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI)\n* High- or very high-risk according to NCCNv1.2023 criteria\n* Signed written informed consent for this study\n* Age \\>18 years\n* Previously conducted PSMA-PET\u002FCT, mpMRI or PSMA-PET\u002FMR\n* MMAI high-risk\n* ECOG Performance score 0 or 1\n* IPSS Score ≤15\n\nExclusion Criteria:\n\n* Prior radiotherapy to the prostate or pelvis\n* Prior radical prostatectomy\n* Prior focal therapy approaches to the prostate\n* Evidence of pelvic nodal disease (cN+) in mpMRI and\u002For PSMA-PET\u002FCT\n* Evidence of distant metastatic disease (cM+) in mpMRI and\u002For PSMA-PET\u002FCT\n* Time gap between the beginning of any systemic therapyADT and conduction of PSMA-PET scans is \\>2 months\n* Evidence of cT4 disease in mpMRI and\u002For PSMA-PET\u002FCT\n* PSA \\>50 ng\u002Fml prior to starting of systemic therapy\n* Expected patient survival \\\u003C5 years\n* Bilateral hip prostheses or any other implants\u002Fhardware that would introduce substantial CT artifacts\n* Contraindication to undergo a MRI scan\n* Contraindication to undergo HDR brachytherapy (brachytherapy not feasible due to large prostate volume, prostate anatomy, tumor in distant seminal vesicles and\u002For unfit for anesthesia)\n* Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization\n* Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia\n* Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival\n* Any other contraindication to external beam radiotherapy (EBRT) to the pelvis\n* Participation in any other interventional clinical trial within the last 30 days before the start of this trial\n* Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed\n* Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial\n* Known or persistent abuse of medication, drugs or alcohol",{"count":50,"type":21},30,[52],"PHASE2","A prospective, single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on multimodal artificial intelligence (MMAI). All patients will receive the current standard of care: (i) a dose escalation to the prostate via HDR brachytherapy, (ii) two years of ADT and (iii) whole-pelvis UHF-RT (5 fractions).",[27],[56,57,58,59],"prostate cancer","multimodal AI","radiotherapy","phase II","2025-03-10",{"date":62,"type":32},"2025-03-11",{"date":64,"type":32},"2024-09-16",{"date":66,"type":21},"2027-08-31",{"name":38,"class":39},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":40},"100575450","phase-2-artificial-intelligence-driven-personalisation-of-radiotherapy-and-concomitant-androgen-deprivation-therapy-for-prostate-cancer-patients-the-hypopro-trial-100575450","NCT06772441","Artificial Intelligence Driven Personalisation of Radiotherapy and Concomitant Androgen Deprivation Therapy for Prostate Cancer Patients (the HypoPro Trial)","Prostate-only, Dose-escalated Radiotherapy Plus Concomitant Androgen Deprivation Therapy in Primary Localized, NCCN High Risk and MMAI Classifier Low or Intermediate-risk Prostate Cancer - a Prospective, Single-arm, Phase II Study","HypoPro","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old)\n2. Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI)\n3. High-risk according to NCCNv4.2023 criteria (cT3a or Grade group 4-5 or PSA \\> 20 ng\u002Fml)\n4. Signed written informed consent for this study\n5. Age \\>18 years\n6. Previously conducted PSMA-PET\u002FCT, mpMRI or PSMA-PET\u002FMR\n7. MMAI low-\u002Fintermediate-risk\n8. ECOG Performance score 0 or 1\n9. IPSS Score ≤15\n10. Prostate biopsy core with the highest ISUP grade available\n\nExclusion Criteria:\n\n1. Prior radiotherapy to the prostate or pelvis\n2. Prior radical prostatectomy\n3. Prior focal therapy approaches to the prostate\n4. Evidence of pelvic nodal disease (cN+) in mpMRI and\u002For PSMA-PET\u002FCT\n5. Evidence of distant metastatic disease (cM+) in mpMRI and\u002For PSMA-PET\u002FCT\n6. Time gap between the beginning of any systemic therapy, ADT and conduction of PSMA-PET scans is \\>2 months\n7. Evidence of cT4 disease in mpMRI and\u002For PSMA-PET\u002FCT\n8. PSA \\>50 ng\u002Fml prior to starting of systemic therapy\n9. Expected patient survival \\\u003C5 years\n10. Bilateral hip prostheses or any other implants\u002Fhardware that would introduce substantial CT artifacts\n11. Contraindication to undergo a MRI scan\n12. Contraindication to undergo HDR brachytherapy (brachytherapy not feasible due to large prostate volume, prostate anatomy, tumor in distant seminal vesicles and\u002For unfit for anaesthesia)\n13. Contraindication to Goserelin\n14. Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization\n15. Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia\n16. Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival\n17. Any other contraindication to external beam radiotherapy (EBRT) to the pelvis\n18. Participation in any other interventional clinical trial within the last 30 days before the start of this trial\n19. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed\n20. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;\n21. Known or persistent abuse of medication, drugs or alcohol\n22. Patients expected to have severe set up problems (e.g. mental condition)",{"count":50,"type":21},[52],"The aim of this prospective, single-arm phase II study is the individualization of both radiotherapy (RT) and androgen deprivation therapy (ADT) duration for patients with high-risk localized prostate cancer (PCa) according to the National Comprehensive Cancer Network (NCCN) based on multimodal artificial intelligence (MMAI) classification. All patients will receive (i) a dose escalation to the prostate via HDR brachytherapy (boost), (ii) twelve months of ADT and (iii) extremely hypofractionated RT to the prostate (5 fractions).\n\nThis way, patients in the HypoPro trial will receive a prostate-only dose escalation and benefit from shortening of the ADT compared with current guideline recommendations.",[27],[81,82,83,84],"artificial intelligence","ADT","radiation therapy","androgen deprivation therapy","2025-01-08",{"date":87,"type":32},"2025-01-13",{"date":89,"type":32},"2024-11-01",{"date":91,"type":21},"2027-10-31",{"name":38,"class":39},""]