Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-27 @ 4:41 AM
Study NCT ID:
NCT03124433
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2017-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572045', 'term': 'apalutamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2017-04-09', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy', 'timeFrame': '24 weeks', 'description': 'This is described as residual cancer burden and treatment response group on histopathology after neoadjuvant apalutamide and radical prostatectomy'}, {'measure': 'Proportion of patients with biochemical treatment response following neoadjuvant apalutamide and radical prostatectomy', 'timeFrame': '24 weeks', 'description': 'Patients who attain serum PSA levels below 0.03microg/L'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients who report significant adverse effects after 12 weeks of neoadjuvant apalutamide', 'timeFrame': '12 weeks', 'description': 'Adverse effects as defined by CTCAE criteria grade 3 and above'}, {'measure': 'The proportion of patients with peri-operative complications following neoadjuvant apalutamide and radical prostatectomy', 'timeFrame': '24 weeks', 'description': 'The level of complications defined by Clavien-Dindo classification'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'prostatectomy, retropubic', 'Androgen Receptor Antagonists'], 'conditions': ['Cancer of the Prostate']}, 'referencesModule': {'references': [{'pmid': '36000794', 'type': 'DERIVED', 'citation': 'Yang X, Allen JC, Aslim EJ, Tay KJ, Yuen SPJ, Kanesvaran R, Chua MLK, Chong TW, Ho SSH, Lee LS. Patient-reported outcomes of a phase II neoadjuvant apalutamide (ARN-509) and radical prostatectomy in treatment of intermediate- to high-risk prostate cancer (NEAR) trial. Int J Urol. 2022 Nov;29(11):1322-1330. doi: 10.1111/iju.14994. Epub 2022 Aug 24.'}, {'pmid': '35091711', 'type': 'DERIVED', 'citation': 'Lee LS, Sim AYL, Ong CW, Yang X, Ng CCY, Liu W, Rajasegaran V, Lim AMS, Aslim EJ, Ngo NT, Khor LY, Kanesvaran R, Allen JCJ, Tay KJ, Yuen JSP, Chong TW, Ho SSH, Teh BT, Chua MLK. NEAR trial: A single-arm phase II trial of neoadjuvant apalutamide monotherapy and radical prostatectomy in intermediate- and high-risk prostate cancer. Prostate Cancer Prostatic Dis. 2022 Apr;25(4):741-748. doi: 10.1038/s41391-022-00496-8. Epub 2022 Jan 28.'}]}, 'descriptionModule': {'briefSummary': "This is an investigator-initiated phase II single arm trial, combining neoadjuvant apalutamide (ARN509) with radical prostatectomy, in the treatment of D'Amico intermediate to high risk organ-confined prostate cancer. Apalutamide has shown efficacy in castrate resistant prostate cancer in phase II studies and are now in phase III trials combined with radiation in organ confined disease.\n\nThe primary study objectives include assessment of (i) oncological efficacy as determined by tumour downstaging and achievement of nadir PSA The secondary study objectives include(i) determination of adverse effects related to apalutamide and surgical complication rates (ii) human prostate tissue effect of apalutamide\n\nThe study will recruit thirty eligible participants who will receive 12 weeks of oral apalutamide 240mg daily. This will be followed by standard-of-care radical prostatectomy. The total trial duration is 26 weeks.", 'detailedDescription': "This is a phase II single arm study looking at the efficacy of 12 weeks of neoadjuvant apalutamide (ARN 509), combined with standard-of-care radical prostatectomy, for D'Amico intermediate to high risk prostate cancer patients. The phases of the study will include: screening, treatment and follow-up phases.\n\nSafety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* histologically diagnosed primary adenocarcinoma of the prostate gland\n* non-metastatic D'Amico intermediate to high risk patients undergoing radical prostatectomy as primary definitive therapy\n* no known hypersensitivity to the study drug\n* able to swallow study drug as whole tablets\n\nExclusion Criteria:\n\n* presence of small cell, neuroendocrine or ductal differentiation at needle biopsy\n* individuals with prior pelvic irradiation therapy for any form of pelvic malignancy\n* patients with psychiatric conditions requiring anti-psychotic therapy, or preventing the provision of informed consent\n* renal impairment with serum creatinine more than twice the upper limit of normal\n* Other prior malignancy less than or equal to 5 years prior to recruitment\n* ECOG performance status 2 or poorer"}, 'identificationModule': {'nctId': 'NCT03124433', 'briefTitle': 'Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in the Treatment of Intermediate to High Risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'ARN509 - 2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant apalutamide', 'description': 'Oral apaluatmide 240mg daily for 12 weeks followed by standard of care robotic radical prostatectomy and pelvic node dissection', 'interventionNames': ['Drug: Apalutamide']}], 'interventions': [{'name': 'Apalutamide', 'type': 'DRUG', 'otherNames': ['ARN509'], 'description': 'Participants will receive oral apalutamide 240mg daily for 12 weeks', 'armGroupLabels': ['Neoadjuvant apalutamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Department of Urology', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Lui Shiong Lee, MBBS,MRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Singapore General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}