Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT06145958
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-24
First Post:
2023-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiotherapy and Androgen Deprivation In Combination After Local Surgery (RADICALS) Translational Study
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': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The primary purpose of this study is to collect fixed tumour material in the previous RADICALS intervention trial. Cases are those receiving therapy vs controls receiving standard of care.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2585}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2028-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2023-11-16', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from Distant Metastases', 'timeFrame': 'Up to 12 years', 'description': 'The absence of prostate cancer metastases'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 12 years', 'description': 'Freedom from death from any cause'}, {'measure': 'Disease Specific Survival', 'timeFrame': 'Up to 12 years', 'description': 'Freedom from prostate cancer specific death'}, {'measure': 'Freedom from treatment failure', 'timeFrame': 'Up to 12 years', 'description': 'Freedom from PSA progression whilst receiving androgen deprivation therapy'}, {'measure': 'Clinical Progression Free survival', 'timeFrame': 'Up to 12 years', 'description': 'Clinical progression of prostate cancer or initiation of non-protocol hormone therapy or death from prostate cancer.'}, {'measure': 'Non protocol hormone therapy', 'timeFrame': 'Up to 12 years', 'description': 'Initiation of hormone therapy other than that randomised.'}, {'measure': 'Freedom from biochemical progression', 'timeFrame': 'Up to 12 years', 'description': 'Where a biochemical progression event is defined as a PSA level of ≥0.4ng/ml following radiotherapy or a PSA level of \\> 2.0ng/ml regardless of prior radiotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biomarker'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this translational study is to test the use of biomarkers in salvage treatment for prostate cancer after a previous operation to remove the prostate. The main question it aims to answer is:\n\n• Can a biomarker identify a group of patients most likely to benefit from androgen deprivation therapy in conjunction with salvage radiotherapy No new participants will be involved, but tumour samples will be acquired, for patients that gave their permission in the completed RADICALS RT and HD studies.', 'detailedDescription': 'Early prostate cancer represents a wide spectrum of disease. Indolent disease is unlikely to ever become symptomatic and treatment is needlessly morbid and costly. Aggressive disease warrants intensification of therapy. Current clinical methods are poor at discriminating these outcomes.\n\nThe RADICALS trial was the largest trial conducted to date in men requiring further curative treatment after an operation. It already defined the role for radiotherapy after surgery (prostatectomy). The standard of care is now for blood test (PSA) monitoring after prostatectomy with radiotherapy offered when the PSA rises. The role and duration of hormone treatment (androgen deprivation), given in combination with radiotherapy, remains less clear. Currently if androgen deprivation is to be given, the RADICALS data support the use of a 24-month course, but this entails a considerable burden of side-effects for patients. Pathological and biological markers are needed to identify those most likely to benefit from androgen deprivation.\n\nIn RADICALS-TR, the investigators will conduct translational analyses on the biopsy and prostatectomy specimens from the RADICALS trial. The investigators aim to identify prognostic features and biomarkers predictive of benefit from androgen therapy. The investigators will prioritise the refinement and validation of clinical biomarkers already close to clinical utilisation. In this way it is hoped that findings can rapidly translate to stratified clinical trials and improved patient care.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were recruited to the RADICALS trial at one of two points:\n\nRT - after surgery for prostate cancer, possessing one or a number of higher risk features for subsequent relapse. These patients were randomised to either immediate radiotherapy or deferred until the point of biochemical relapse.\n\nHD - at the point of intiation of radiotherapy in the adjuvant or salvage setting. These patients were randomised to a number of different androgen deprivation durations (as detailed above in the cohort descriptions).', 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\nInclusion criteria:\n\nDiagnosis of nonmetastatic adenocarcinoma of the prostate Must have undergone radical prostatectomy Post-operative serum prostate-specific antigen (PSA) \\< 0.4 ng/mL No post-operative biochemical failure, defined as EITHER two consecutive rises in PSA and final PSA \\> 0.1 ng/mL OR three consecutive rises in PSA (for patients undergoing hormone therapy duration randomization)\n\nExclusion criteria:\n\nKnown distant metastases from prostate cancer PSA \\> 5 ng/mL at the time of hormone randomization (for patients undergoing hormone therapy duration randomization)\n\nPATIENT CHARACTERISTICS:\n\n* No other active malignancy likely to interfere with protocol treatment or follow-up.\n* Consent has been given within the RADICALS (RT/HD) trial to translational research and follow up.\n\nPRIOR CONCURRENT THERAPY:\n\nInclusion criteria:\n\nSee Disease Characteristics Co-enrollment to other trials is permitted, providing this does not interfere with the outcome measures 5-α reductase inhibitors, soya, selenium, and vitamin E are acceptable non-trial therapies\n\nExclusion criteria:\n\nPrior hormone therapy Bilateral orchidectomy Prior pelvic radiotherapy Neoadjuvant treatment Other concurrent therapies for prostate cancer (e.g., estrogens or cytotoxic chemotherapy) prior to disease progression'}, 'identificationModule': {'nctId': 'NCT06145958', 'acronym': 'RADICALS-TR', 'briefTitle': 'Radiotherapy and Androgen Deprivation In Combination After Local Surgery (RADICALS) Translational Study', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'A Translational Study of Samples From the Radiotherapy and Androgen Deprivation In Combination After Local Surgery (RADICALS) Prostate Cancer Trial to Identify Those Most Likely to Benefit From Androgen Deprivation With Salvage Radiotherapy', 'orgStudyIdInfo': {'id': '159874'}, 'secondaryIdInfos': [{'id': '329626', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'No androgen deprivation', 'description': 'Those patients not given androgen deprivation therapy'}, {'label': 'Short course androgen deprivation', 'description': 'Those patients given 6 months of androgen deprivation therapy', 'interventionNames': ['Drug: Luteinising Hormone-Releasing Factor Analogue']}, {'label': 'Long course androgen deprivation', 'description': 'Those patients given 24 months of androgen deprivation therapy', 'interventionNames': ['Drug: Luteinising Hormone-Releasing Factor Analogue']}], 'interventions': [{'name': 'Luteinising Hormone-Releasing Factor Analogue', 'type': 'DRUG', 'description': 'Androgen Deprivation Therapy', 'armGroupLabels': ['Long course androgen deprivation', 'Short course androgen deprivation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Matthew W Fittall, BMBCh PhD', 'role': 'CONTACT', 'email': 'Matthew.Fittall@ucl.ac.uk', 'phone': '020 7679 6500'}], 'overallOfficials': [{'name': 'Matthew W Fittall, BMBCh PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'On request - clinical outcome data is available from the RADICALS trial team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}