Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-31 @ 5:47 AM
Study NCT ID:
NCT04845503
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-20
First Post:
2021-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-03-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity or Discontinuation of Therapy', 'timeFrame': 'Within 1 Year', 'description': 'One of the the following events are counted as an Event (Number of Participants affected):\n\n* any urogenital or gastrointestinal grade ≥ 2 toxicity within one year after the start of RT (according to NCI CTCAE Version 5.0)\n* Discontinuation of therapy, with a connection to the study treatment'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Within 1 year and within 5 years', 'description': 'Mortality due to study treatment or due to prostate Cancer (Number of Participants deceased)'}, {'measure': 'Number of Toxicities', 'timeFrame': 'Within 1 year and within 5 years after start of radiotherapy', 'description': 'Number and severity of urogenital or gastrointestinal toxicity'}, {'measure': 'bPFS', 'timeFrame': 'from start of radiotherapy (day 1) until PSA-relapse according to Phoenix-Criteria (Prostate-specific antigen (PSA) nadir + 2 ng/mL after radiotherapy), assessed up to 5 years', 'description': 'biochemical progression free survival'}, {'measure': 'Hormone therapy-free Survival', 'timeFrame': 'from start of radiotherapy until start of hormon treatment; maximum 3 months neoadjuvant', 'description': 'Hormone therapy-free Survival'}, {'measure': 'OS', 'timeFrame': 'from start of radiotherapy (day 1) until death or censoring assessed up to 5 years', 'description': 'overall survival'}, {'measure': 'Quality of life according to EORTC QLQ-C30', 'timeFrame': 'from start of radiotherapy (day 1) until end of follow-up (up to 5 years)', 'description': 'Quality of life according to EORTC QLQ-C30'}, {'measure': 'Quality of life according to EORTC QLQ-PR25', 'timeFrame': 'from start of radiotherapy (day 1) until end of follow-up (up to 5 years)', 'description': 'Quality of life according to EORTC QLQ-PR25'}, {'measure': 'Symptoms and Toxicity', 'timeFrame': 'from start of radiotherapy (day 1) until end of follow-up (up to 5 years)', 'description': 'Symptoms and Toxicity according to NCI CTCAE (Rate)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'As the most common carcinoma in men, prostate cancer is a significant tumor entity in oncology. In addition to the surgical approach, definitive radiotherapy is an equivalent therapy alternative in the non-metastatic primary situation. However, radiotherapy usually stretches over a period of several weeks (7 to 8 weeks) during which the patient receives irradiation on a daily basis. For this reason and for radiobiological considerations the total treatment time is increasingly shortened. It has been shown in several randomized phase III studies that shorting radiotherapy to about 4 weeks by increasing the single dose (so-called hypofractionation) is possible. Meanwhile there is also more data on extreme hypofractionation (max. 10 radiation sessions) available, however often times, extensive preparations are necessary (such as the invasive introduction of markers into the prostate). The current, prospective, non-randomized, multicentric, Phase II SMILE study is now testing whether the MRI-guided radiotherapy with a greatly shortened radiotherapy of the prostate over 5 radiation sessions is possible and safe.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed prostate carcinoma with tissue classification according to Gleason score and PSA\n* low- or intermediate-risk carcinoma according to d'Amico criteria or early high-risk Carcinoma (cT3a and / or GS ≤ 8 and / or PSA ≤ 20ng / ml)\n* IPSS (International Prostate Symptom Score) max. 12\n* Prostate volume \\<80cm³\n* Karnofsky index ≥ 70%\n* Age ≥ 18 years\n* Patient information provided and written consent\n* Ability of the patient to give consent\n\nExclusion Criteria:\n\n* Previous radiotherapy in the pelvis\n* Previous local therapy of the prostate\n* lymphogenic metastasis\n* Stage IV (distant metastases)\n* Contraindication to MRI\n* Simultaneous participation in another clinical study which could influence results of either of the respective study"}, 'identificationModule': {'nctId': 'NCT04845503', 'acronym': 'SMILE', 'briefTitle': 'Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer', 'orgStudyIdInfo': {'id': 'SMILE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MR-guided Radiotherapy (5 x 7,5 Gy)', 'description': '5 x 7,5 Gy prescribed on the PTV', 'interventionNames': ['Radiation: MR-guided Radiotherapy']}], 'interventions': [{'name': 'MR-guided Radiotherapy', 'type': 'RADIATION', 'description': 'Total Dose 37,5 Gy, Single Dose 7,5 Gy, 5 Fractions applied in 1-2 weeks', 'armGroupLabels': ['MR-guided Radiotherapy (5 x 7,5 Gy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University Hospital of Heidelberg, Radiation Oncology', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'University Hospital, Zürich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director RadioOncology', 'investigatorFullName': 'Juergen Debus', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}