Ignite Creation Date:
2025-12-17 @ 3:06 PM
Ignite Modification Date:
2025-12-23 @ 10:50 PM
Study NCT ID:
NCT00764166
Status:
UNKNOWN
Last Update Posted:
2008-10-01
First Post:
2008-09-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563250', 'term': 'Salivary Gland Adenoma, Pleomorphic'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-09-30', 'studyFirstSubmitDate': '2008-09-30', 'studyFirstSubmitQcDate': '2008-09-30', 'lastUpdatePostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint was the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).', 'timeFrame': 'Every month during 5 years.'}], 'secondaryOutcomes': [{'measure': 'Secondary endpoints were metastasis-free survival, PSA response (decrease > 50 % of the PSA), overall survival, cancer specific survival, safety and quality of life (QoL).', 'timeFrame': 'Every month during 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PSA (biochemical)', 'Progression- free Survival', 'Clinical progress', 'Overall survival', 'Tolerance to the treatment', 'Quality of Live'], 'conditions': ['Adenocarcinoma of the Prostate']}, 'referencesModule': {'references': [{'pmid': '30703190', 'type': 'DERIVED', 'citation': 'Oudard S, Latorzeff I, Caty A, Miglianico L, Sevin E, Hardy-Bessard AC, Delva R, Rolland F, Mouret L, Priou F, Beuzeboc P, Gravis G, Linassier C, Gomez P, Voog E, Muracciole X, Abraham C, Banu E, Ferrero JM, Ravaud A, Krakowski I, Lagrange JL, Deplanque G, Zylberait D, Bozec L, Houede N, Culine S, Elaidi R. Effect of Adding Docetaxel to Androgen-Deprivation Therapy in Patients With High-Risk Prostate Cancer With Rising Prostate-Specific Antigen Levels After Primary Local Therapy: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):623-632. doi: 10.1001/jamaoncol.2018.6607.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective was to evaluate the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).\n\nThe study was powered at 80% to detect a 25% improvement in biochemical PFS for a total sample size estimated at 252 patients, with a two-sided type I error rate of 5% (non-parametric methods.', 'detailedDescription': 'Docetaxel was shown to be active in metastatic hormone-refractory prostate cancer (PC) in phase III trials (1-2). It is likely to demonstrate a substantial role in the management of early-stage PC patients in the neoadjuvant and adjuvant settings, where clinical trials are underway.•53% of all men who undergo radical prostatectomy will develop prostate-specific antigen (PSA) elevations in the 10 years following surgery, with approximately 77% of these recurrences occurring within the first 2 years.A prospective, multicenter, national, randomized, two-arm, phase III study comparing hormonal treatment (LH-RH agonist alone) with or without docetaxel was designed to evaluate the interest of chemotherapy in non-metastatic prostate cancer patients at high risk of systemic recurrence after initial treatment (radical prostatectomy or radiotherapy).\n\n1. PETRYLAK DP, et al: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513-1520, 2004\n2. TANNOCK IF, de Wit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512, 2004'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically documented adenocarcinoma of the prostate\n* Previous treatment with either radical prostatectomy or radiation therapy\n* Salvage radiotherapy for local relapse allowed\n* Neoadjuvant or per radiotherapy Hormonal therapy allowed in case of more than 6 months free-interval before first rising PSA\n* Life expectancy of more than 12 months\n* Non metastatic disease documented by imaging including radionuclide bone scan\n* ECOG performance status 0-1\n* ANC \\> 1,500/mm3\n* Platelet counts \\> 100,000/mm3\n* SGOT and/or SGPT may be up to 2.5 x ULN\n\nPatients at high risk of biological relapse defined by:\n\n* Gleason \\> 8\n* PSA-DT \\< 6 months\n* Positive surgical margins\n* PSA velocity \\> 0.75 ng/mL/year\n* Pathological pelvic lymph nodes involvement (pN+)\n* Time from initial treatment until inclusion \\< 12 months\n\nExclusion Criteria:\n\n* Prior chemotherapy by taxanes and estramustine phosphate\n* Documented local recurrence of prostate cancer or documented metastatic disease\n* History of other malignancy within the last 5 years other than curatively treated basal cell carcinoma of the skin\n* Active infection\n* Significant cardiac disease, angina pectoris or myocardial infarction within twelve months\n* Clinically significant neuropathy\n* Medical condition requiring the use of concomitant corticosteroids\n* Prohibited concomitant therapy with experimental drug.\n* Participation in another clinical trial for the period \\< 30 days'}, 'identificationModule': {'nctId': 'NCT00764166', 'acronym': 'RisingPSA', 'briefTitle': 'A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Non-Metastatic High-Risk Prostate Cancer Patients With Biochemical Relapse Only After Local Treatment. A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel', 'orgStudyIdInfo': {'id': 'AOM 03108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Docetaxel + hormonal treatment (LH-RH agonist)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Hormonal treatment (LH-RH agonist)']}], 'interventions': [{'name': 'Docetaxel + hormonal treatment (LH-RH agonist)', 'type': 'DRUG', 'description': 'Docetaxel will be administered:\n\n* To D1 of every cycle in the dose of 70 mg/m²,\n* Perfusion IV of 60 minutes diluted in 250 ml with physiological serum or with serum glucoside from a peripheral or central vein, Every 3 weeks during 6 cycles (except when unacceptable tolerance).\n\nTriptorelin was given by injection for 4 times every 3 months Bicalutamide was given at the same time with LH-RH agonist for 3 weeks ; taken orally', 'armGroupLabels': ['1']}, {'name': 'Hormonal treatment (LH-RH agonist)', 'type': 'DRUG', 'description': 'Triptorelin was given by injection for 4 times every 3 months. Bicalutamide given at the same time with LH-RH agonist for 3 weeks ; taken orally.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Service Oncologie Médicale, Hopital Europeen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Stephane Oudard, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Georges Pompidou Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'ARTIC group (oncologists and urologists association)', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Aurélie Guimfack', 'oldOrganization': 'Department Clinical Research of Developpement'}}}}