Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-02-03 @ 7:16 AM
Study NCT ID:
NCT00554918
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2007-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel and Prednisolone With or Without Zoledronic Acid and/or Strontium Chloride Sr 89 in Treating Patients With Prostate Cancer Metastatic to Bone That Has Not Responded to Hormone Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D000077211', 'term': 'Zoledronic Acid'}, {'id': 'C025700', 'term': 'strontium chloride'}], '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': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2007-11-06', 'studyFirstSubmitQcDate': '2007-11-06', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety'}, {'measure': 'Toxicity and tolerability of docetaxel and zoledronic acid'}, {'measure': 'Toxicity and tolerability of docetaxel and strontium chloride Sr 89'}, {'measure': 'Toxicity and tolerability of docetaxel, zoledronic acid, and strontium chloride Sr 89'}], 'secondaryOutcomes': [{'measure': 'Health Care economic analysis'}, {'measure': 'Changes in bone mineral density'}, {'measure': 'Median time to disease progression'}, {'measure': 'Pain progression-free survival (PFS)'}, {'measure': 'PSA PFS'}, {'measure': 'Pain response'}, {'measure': 'Overall survival'}, {'measure': 'Quality of life'}]}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'recurrent prostate cancer', 'stage IV prostate cancer', 'bone metastases'], 'conditions': ['Metastatic Cancer', 'Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '33270906', 'type': 'DERIVED', 'citation': 'Jakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Zoledronic acid may help relieve some of the symptoms caused by bone metastases. Radioactive substances, such as strontium chloride Sr 89, may help relieve bone pain caused by prostate cancer. Giving docetaxel together with prednisolone with or without zoledronic acid and/or strontium chloride Sr 89 may kill more tumor cells.\n\nPURPOSE: This randomized phase II trial is studying the side effects and how well giving docetaxel together with prednisolone works with or without zoledronic acid and/or strontium chloride Sr 89 in treating patients with prostate cancer metastatic to bone that has not responded to hormone therapy.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To assess the toxicity and tolerability of docetaxel with zoledronic acid.\n* To assess the toxicity and tolerability of docetaxel with strontium chloride Sr 89.\n* To assess the toxicity and tolerability of docetaxel with zoledronic acid and strontium chloride Sr 89.\n\nSecondary\n\n* Compare health economic endpoints between the treatment groups.\n* Compare changes in bone mineral density between the treatment groups.\n* Compare the biological profiling for prognostic and predictive indicators between the treatment groups.\n\nTertiary\n\n* Compare median time to disease progression between the treatment groups.\n* Compare pain progression-free survival (PFS) between the treatment groups.\n* Compare PSA PFS between the treatment groups.\n* Compare pain response between the treatment groups.\n* Compare overall survival between the treatment groups.\n* Compare quality of life between the treatment groups.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to treatment center and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 4 treatment arms.\n\n* Arm I: Patients receive docetaxel IV on day 1 and oral prednisolone once daily.\n* Arm II: Patients receive docetaxel and prednisolone as in arm I and zoledronic acid IV over 15 minutes on day 1.\n* Arm III: Patients receive docetaxel and prednisolone as in arm I and a single dose of strontium chloride Sr 89 IV on day 7 of course 2.\n* Arm IV: Patients receive docetaxel and prednisolone as in arm I, zoledronic acid as in arm II, and strontium chloride Sr 89 as in arm III.\n\nTreatment with docetaxel, prednisolone, and zoledronic acid repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Strontium chloride Sr 89 is given as a one time single dose.\n\nQuality of life is assessed using the Euroqual (EQ-5D) and FACT-P at baseline and every 3 months during follow up.\n\nAfter completion of study, patients are followed every 3 months.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of 1 of the following:\n\n * Histologically or cytologically proven prostate adenocarcinoma\n * Multiple sclerotic bone metastases with PSA ≥ 100 ng/mL without histological confirmation\n* Radiological evidence of bone metastasis\n* Prior hormonal therapy for prostate cancer including ≥ 1 of the following:\n\n * Bilateral orchidectomy\n * Medical castration by luteinizing hormone-releasing hormone (LHRH) agonist therapy\n\n * If receiving LHRH agonist therapy alone, this therapy should be continued\n* Documented disease progression, defined by one of the following:\n\n * Progressive disease after discontinuing hormone therapy\n * Elevated and rising PSA, defined as 2 consecutive increases in PSA documented over a previous reference value\n * PSA \\> 5ng/mL\n * Progression of any unidimensionally or bidimensionally measurable malignant lesion\n * At least 1 new lesion identified on bone scan\n* No known brain or leptomeningeal metastases\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Life expectancy ≥ 3 months\n* Hemoglobin ≥ 10g/dL\n* ANC ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Creatinine ≤ 1.5 times upper limit of normal (ULN)\n* ALT and AST ≤ 1.5 times ULN (unless related to hepatic metastatic disease, where patients may be entered after discussion with one of the clinical advisors)\n* Serum bilirubin ≤ 1.5 times ULN\n* Physically fit enough to receive trial treatment\n* No malignant disease within the past 5 years, other than adequately treated basal cell carcinoma\n* No symptomatic peripheral neuropathy ≥ grade 2 (NCI CTC)\n* No known hypersensitivity to bisphosphonates\n* No condition, in the opinion of the investigator, that may interfere with the safety of the patient or evaluation of the study objectives\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* At least 4 weeks since prior flutamide, nilutamide, or cyproterone acetate with evidence of disease progression since cessation\n* At least 6 weeks since prior bicalutamide with evidence of disease progression since cessation\n* At least 4 weeks since prior estramustine and any adverse events must have resolved\n* At least 2 months since prior treatment with a bisphosphonate for any reason\n* No treatment with any other investigational compound within the past 30 days\n* No prior cytotoxic chemotherapy for hormone refractory prostate cancer (HRPC), other than estramustine monotherapy\n* No prior radionuclide therapy for HRPC\n* No prior radiotherapy to more than 25% of the bone marrow or whole pelvic irradiation\n* No concurrent enrollment in any other investigational clinical trial'}, 'identificationModule': {'nctId': 'NCT00554918', 'briefTitle': 'Docetaxel and Prednisolone With or Without Zoledronic Acid and/or Strontium Chloride Sr 89 in Treating Patients With Prostate Cancer Metastatic to Bone That Has Not Responded to Hormone Therapy', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomised Phase II Feasibility Study of Docetaxel (Taxotere®) Plus Prednisolone vs. Docetaxel (Taxotere®) Plus Prednisolone Plus Zoledronic Acid (Zometa®) vs. Docetaxel (Taxotere®) Plus Prednisolone Plus Strontium-89 vs. Docetaxel (Taxotere®) Plus Prednisolone Plus Zoledronic Acid (Zometa®) Plus Strontium-89 in Hormone Refractory Prostate Cancer Metastatic to Bone.', 'orgStudyIdInfo': {'id': 'CRUK-TRAPEZE-2100'}, 'secondaryIdInfos': [{'id': 'CDR0000574585', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EUDRACT-2004-002295-41'}, {'id': 'EU-20782'}, {'id': 'ISRCTN12808747'}, {'id': 'SANOFI-AVENTIS-CRUK-TRAPEZE-21'}, {'id': 'NOVARTIS-CRUK-TRAPEZE-2100'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'docetaxel', 'type': 'DRUG'}, {'name': 'prednisolone', 'type': 'DRUG'}, {'name': 'zoledronic acid', 'type': 'DRUG'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE'}, {'name': 'strontium chloride Sr 89', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TH', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'GL53 7AN', 'city': 'Cheltenham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Gloucestershire Oncology Centre at Cheltenham General Hospital', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}, {'zip': 'GL1 3NN', 'city': 'Gloucester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Gloucestershire Royal Hospital', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}, {'zip': 'IP4 5PD', 'city': 'Ipswich', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'zip': 'ME16 9QQ', 'city': 'Maidstone', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Mid Kent Oncology Centre at Maidstone Hospital', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden - Surrey', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'WS2 9PS', 'city': 'Walsall', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Walsall Manor Hospital', 'geoPoint': {'lat': 52.58528, 'lon': -1.98396}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'KA6 6DX', 'city': 'Ayr', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Ayr Hospital', 'geoPoint': {'lat': 55.46273, 'lon': -4.63393}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Edinburgh Cancer Centre at Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Beatson West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'KA2 OBE', 'city': 'Kilmarnock', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Crosshouse Hospital', 'geoPoint': {'lat': 55.61171, 'lon': -4.49581}}, {'zip': 'ML2 0DP', 'city': 'Wishaw', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Wishaw General Hospital', 'geoPoint': {'lat': 55.76667, 'lon': -3.91667}}, {'zip': 'CF14 2TL', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Velindre Cancer Center at Velindre Hospital', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'LL 18 5UJ', 'city': 'Rhyl, Denbighshire', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Glan Clwyd Hospital', 'geoPoint': {'lat': 53.31929, 'lon': -3.49228}}], 'overallOfficials': [{'name': 'Nicholas D. James, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Birmingham', 'class': 'OTHER'}}}}