{
  "id": "ctis:2024-510707-11-00",
  "euct": "2024-510707-11-00",
  "title": "Artificial Intelligence driven personalisation of radiotherapy and concomitant androgen deprivation therapy for prostate cancer patients",
  "publicTitle": "Artificial Intelligence driven personalisation of radiotherapy and concomitant androgen deprivation therapy for prostate cancer patients",
  "fullTitle": "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",
  "shortTitle": "HypoPro",
  "status": "Authorised",
  "statusCode": "4",
  "startDateEU": "2024-10-21",
  "decisionDate": "2024-05-29T11:18:13.203",
  "publishDate": "2025-10-07T04:07:02.521736825",
  "trialRegion": "EEA",
  "trialRegionCode": "1",
  "medicalConditions": [
    {
      "name": "Prostate cancer",
      "rareDisease": false
    }
  ],
  "therapeuticAreas": [
    {
      "code": "4",
      "name": "Diseases [C] - Neoplasms [C04]"
    }
  ],
  "trialCategory": {
    "phaseCode": "4",
    "categoryCode": "3",
    "lowIntervention": true
  },
  "duration": {
    "estimatedRecruitmentStartDate": "2024-03-01",
    "estimatedEndDate": "2026-09-30",
    "estimatedGlobalEndDate": null
  },
  "countries": [
    {
      "name": "Cyprus",
      "publicStatusCode": "4",
      "firstDecisionDate": "2024-05-29T11:18:13.203",
      "lastDecisionDate": "2025-02-26T09:32:47.109",
      "history": [
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          "applicationBusinessKey": "IN",
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          "status": "Authorised",
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          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2024-05-27",
          "date": "2024-05-29",
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          "applicationStatusCode": "Authorised"
        },
        {
          "source": "application_country_status",
          "applicationBusinessKey": "SM-2",
          "applicationType": "SUBSTANTIAL MODIFICATION",
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          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2025-02-26",
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          "isRMS": true
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          "status": "Authorised",
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          "date": "2025-02-26T09:32:47.109",
          "isRMS": true
        }
      ]
    }
  ],
  "applications": [
    {
      "id": "application:2024-510707-11-00:in",
      "businessKey": "IN",
      "type": "INITIAL",
      "status": "Authorised",
      "trialStatus": "Authorised",
      "submissionDate": "2024-02-13",
      "decisionDate": "2024-05-29",
      "decisions": [
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          "mscName": "Cyprus",
          "decisionDate": "2024-05-29T11:18:13.203",
          "decision": "authorized",
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          "isRMS": true
        }
      ],
      "countryStatuses": [
        {
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          "decisionDate": "2024-05-29",
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          "assessmentOutcomeDate": "2024-05-27",
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      ]
    },
    {
      "id": "application:2024-510707-11-00:sm-2",
      "businessKey": "SM-2",
      "type": "SUBSTANTIAL MODIFICATION",
      "status": "Authorised",
      "trialStatus": "Authorised",
      "submissionDate": "2025-01-07",
      "decisionDate": "2025-02-26",
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        {
          "mscName": "Cyprus",
          "decisionDate": "2025-02-26T09:32:47.109",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "applicationType": "SUBSTANTIAL MODIFICATION",
          "isRMS": true
        }
      ],
      "countryStatuses": [
        {
          "countryName": "Cyprus",
          "mscName": "Cyprus",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "decisionDate": "2024-05-29",
          "firstDecisionDate": "2024-05-29",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2025-02-26",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        }
      ]
    }
  ],
  "evidence": [
    {
      "id": "evidence:cec585a404e599f9b0a77ba0",
      "path": "authorizedApplication.authorizedPartI.trialDetails.clinicalTrialIdentifiers.publicTitle",
      "term": "artificial intelligence",
      "snippet": "Artificial Intelligence driven personalisation of radiotherapy and concomitant androgen deprivation therapy for prostate cancer patients"
    },
    {
      "id": "evidence:1fd58ea0ade90becc7866e8b",
      "path": "authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.mainObjective",
      "term": "artificial intelligence",
      "snippet": "The individualization of radiotherapy (RT) based on prostate-specific membrane antigen positron emission tomography / computed tomography (PSMA PET/CT) imaging and a multimodal artificial intelligence (MMAI) system in terms de-intensification of hormonal therapy in parallel to ultra-hypofractionated RT and dose escalation to the prostate has no decreased disease-free survival.…"
    }
  ],
  "official": {
    "retrieveUrl": "https://euclinicaltrials.eu/ctis-public-api/retrieve/2024-510707-11-00",
    "publicUrl": "https://euclinicaltrials.eu/ctis-public/view/2024-510707-11-00?lang=en"
  },
  "slug": "2024-510707-11-00",
  "firstObservedAt": "2026-07-23T11:19:41.794Z",
  "lastObservedAt": "2026-07-23T13:03:56.000Z",
  "dateModified": "2026-07-23",
  "materialFingerprint": "55e43d7d7a130be3f3de561fbe19a99e7ab704897b3eb762fcff0cffc4810f5b"
}