Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT01517451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2012-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation and Androgen Ablation for Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D000726', 'term': 'Androgen Antagonists'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2012-01-20', 'studyFirstSubmitQcDate': '2012-01-20', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical failure free-rate', 'timeFrame': '1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed', 'description': 'To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.'}], 'secondaryOutcomes': [{'measure': 'Various Control Rate Assessments', 'timeFrame': '1 year', 'description': 'Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT.'}, {'measure': 'Dose Volume/ Imaging Data Assessments', 'timeFrame': '1 year', 'description': 'Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.'}, {'measure': 'Biomarker Studies', 'timeFrame': '1 year', 'description': 'Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.'}, {'measure': 'Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment', 'timeFrame': '1 year', 'description': '1\\) Assess the incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adenocarcinoma of the Prostate']}, 'descriptionModule': {'briefSummary': 'A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.', 'detailedDescription': 'This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed, locally confined adenocarcinoma of the prostate\n* Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7).\n* The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer.\n* Signed study-specific consent form prior to registration\n\nExclusion Criteria:\n\n* Stage T3-4 disease.\n* Gleason 8 or higher score.\n* PSA \\> 20 ng/ml.\n* IPSS (International Prostate Symptom Score) \\> 15\n* Clinical or Pathological Lymph node involvement (N1).\n* Evidence of distant metastases (M1).\n* Radical surgery for carcinoma of the prostate.\n* Previous Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer.\n* Previous pelvic radiation therapy.\n* Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years.\n* History of inflammatory bowel disease.\n* Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.\n* Myocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11\n* Liver function tests (LFTs) greater than twice the upper limit of normal."}, 'identificationModule': {'nctId': 'NCT01517451', 'briefTitle': 'Radiation and Androgen Ablation for Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate', 'orgStudyIdInfo': {'id': 'J11157'}, 'secondaryIdInfos': [{'id': 'NA_00067963', 'type': 'OTHER', 'domain': 'JHMIRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiation with Androgen Deprivation Therapy (ADT)', 'description': 'This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.', 'interventionNames': ['Radiation: Radiation Therapy', 'Drug: Androgen Deprivation Therapy (ADT)']}], 'interventions': [{'name': 'Radiation Therapy', 'type': 'RADIATION', 'description': '7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)', 'armGroupLabels': ['Radiation with Androgen Deprivation Therapy (ADT)']}, {'name': 'Androgen Deprivation Therapy (ADT)', 'type': 'DRUG', 'description': 'Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.', 'armGroupLabels': ['Radiation with Androgen Deprivation Therapy (ADT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Sibley Memorial Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Suburban Hospital', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Daniel Song, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}