Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-06 @ 7:41 AM
Study NCT ID:
NCT02145494
Status:
UNKNOWN
Last Update Posted:
2014-05-23
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-20', 'studyFirstSubmitDate': '2013-06-04', 'studyFirstSubmitQcDate': '2014-05-20', 'lastUpdatePostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute genitourinary(GU) toxicity', 'timeFrame': 'Maximal recorded toxicity within the acute toxicity period (up to 12 weeks)', 'description': 'RTOG scale acute GU toxicity will be measured at baseline, end of treatment, then 2,4 and 12 weeks post treatment. The maximal toxicity during follow up is the primary outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Acute gastrointestinal (GI) toxicity', 'timeFrame': 'Within 12 weeks of treatment completion', 'description': 'RTOG scale'}, {'measure': 'Late GI and GU toxicity', 'timeFrame': 'From 12 weeks until study completion', 'description': 'RTOG scale'}, {'measure': 'Patient reported outcomes i.e. IPSS, IIEF-5 and EQ5-D', 'timeFrame': 'Baseline, 12 weeks, 12 months and 6 monthly to 5 years', 'description': 'IPSS, IIEF-5 and EQ5-D'}, {'measure': 'Biochemical relapse-free survival', 'timeFrame': 'Measured at 12 weeks after completion of treatment and 3-6 monthly to 5 years thereafter', 'description': 'PSA will be measured 3-6 monthly during study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SBRT (stereotactic body radiotherapy)', 'Focal boost', 'Prostate'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Giving a higher dose of radiation to the dominant tumour nodule within the prostate is hypothesized to improve tumour control. This trial will assess whether this technique, delivered in 5 treatments, can be delivered without increasing side effects.', 'detailedDescription': 'Aim To assess if a focal boost can be delivered to the dominant tumour nodule alongside 36.25 Gy in 5 fractions to the whole prostate gland.\n\nPrimary end-point: Acute toxicity (Radiation Therapy Oncology Group (RTOG), International prostate symptom score (IPSS))\n\nSecondary end-points: Prostate specific antigen (PSA) nadir and 2-year biochemical control Late toxicity (IPSS, RTOG, International index of erectile function (IIEF-5)) Quality of life (EQ5D scale)\n\nInclusion criteria\n\n* Prostate cancer patients with any of the following:\n* PSA\\>20\n* Gleason grade 4+3 or higher\n* Stage T3a\n* Exclusion criteria\n* Nodal or metastatic disease\n* PSA\\>40\n* Stage T3b or higher\n\nStudy interventions\n\nThis is a phase II study which will recruit 20 patients. A dose of 36.25 Gy in 5 fractions will be delivered to the whole prostate with a simultaneous integrated boost up to 47.5 Gy in 5 fractions or to the highest dose possible within dose constraints. The boost volume will be defined on the multiparametric magnetic resonance scan by the specialist radiologist.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nProstate cancer patients with any of the following:\n\n* PSA 20-40\n* Gleason grade 4+3 or higher\n* Stage T3a\n\nExclusion Criteria:\n\n* Nodal or metastatic disease\n* PSA\\>40\n* Stage T3b or higher'}, 'identificationModule': {'nctId': 'NCT02145494', 'acronym': 'SPARC', 'briefTitle': 'The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'Stereotactic Prostate Augmented Radiotherapy With Cyberknife', 'orgStudyIdInfo': {'id': '13/LO/0109'}, 'secondaryIdInfos': [{'id': 'CCR 3923', 'type': 'OTHER', 'domain': 'Royal Marsden NHS Foundation Trust'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Radiotherapy', 'interventionNames': ['Radiation: Radiotherapy']}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'otherNames': ['Cyberknife'], 'description': 'Stereotactic body radiotherapy (SBRT) to the whole prostate (36.25 Gy in 5 fractions) with a focal boost (47.5 Gy in 5 fractions) to the MRI-defined dominant tumour nodule.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6JJ', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Daniel R Henderson, FRCR', 'role': 'CONTACT', 'email': 'daniel.henderson@rmh.nhs.uk'}, {'name': 'Nicholas J van As, FRCR', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alison C Tree, FRCR', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Royal Marsden NHS Foundation trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Nicholas J van As, FRCR', 'role': 'CONTACT', 'phone': '02078118336'}, {'name': 'Daniel R Henderson, FRCR', 'role': 'CONTACT', 'phone': '02078118469'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}