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

NCT00554918 | Completed Phase 2

• 7 other identifiers: CRUK-TRAPEZE-2100CDR0000574585EUDRACT-2004-002295-41EU-20782ISRCTN12808747SANOFI-AVENTIS-CRUK-TRAPEZE-21NOVARTIS-CRUK-TRAPEZE-2100
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 16

Brief Summary

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. PURPOSE: 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.

Conditions

Metastatic Cancer; Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer; bone metastases

Outcome Measures

Primary Outcomes (4)

• Safety

• Toxicity and tolerability of docetaxel and zoledronic acid

• Toxicity and tolerability of docetaxel and strontium chloride Sr 89

• Toxicity and tolerability of docetaxel, zoledronic acid, and strontium chloride Sr 89

Secondary Outcomes (8)

• Health Care economic analysis

• Changes in bone mineral density

• Median time to disease progression

• Pain progression-free survival (PFS)

• PSA PFS

Interventions

docetaxel DRUG

prednisolone DRUG

zoledronic acid DRUG

quality-of-life assessment PROCEDURE

strontium chloride Sr 89 RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Histologically or cytologically proven prostate adenocarcinoma * Multiple sclerotic bone metastases with PSA ≥ 100 ng/mL without histological confirmation * Radiological evidence of bone metastasis * Prior hormonal therapy for prostate cancer including ≥ 1 of the following: * Bilateral orchidectomy * Medical castration by luteinizing hormone-releasing hormone (LHRH) agonist therapy * If receiving LHRH agonist therapy alone, this therapy should be continued * Documented disease progression, defined by one of the following: * Progressive disease after discontinuing hormone therapy * Elevated and rising PSA, defined as 2 consecutive increases in PSA documented over a previous reference value * PSA \> 5ng/mL * Progression of any unidimensionally or bidimensionally measurable malignant lesion * At least 1 new lesion identified on bone scan * No known brain or leptomeningeal metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Hemoglobin ≥ 10g/dL * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 times upper limit of normal (ULN) * 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) * Serum bilirubin ≤ 1.5 times ULN * Physically fit enough to receive trial treatment * No malignant disease within the past 5 years, other than adequately treated basal cell carcinoma * No symptomatic peripheral neuropathy ≥ grade 2 (NCI CTC) * No known hypersensitivity to bisphosphonates * No condition, in the opinion of the investigator, that may interfere with the safety of the patient or evaluation of the study objectives PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior flutamide, nilutamide, or cyproterone acetate with evidence of disease progression since cessation * At least 6 weeks since prior bicalutamide with evidence of disease progression since cessation * At least 4 weeks since prior estramustine and any adverse events must have resolved * At least 2 months since prior treatment with a bisphosphonate for any reason * No treatment with any other investigational compound within the past 30 days * No prior cytotoxic chemotherapy for hormone refractory prostate cancer (HRPC), other than estramustine monotherapy * No prior radionuclide therapy for HRPC * No prior radiotherapy to more than 25% of the bone marrow or whole pelvic irradiation * No concurrent enrollment in any other investigational clinical trial

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital Birmingham: lead

Study Sites (16)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Mid Kent Oncology Centre at Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Walsall Manor Hospital

Walsall, England, WS2 9PS, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ayr Hospital

Ayr, Scotland, KA6 6DX, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Crosshouse Hospital

Kilmarnock, Scotland, KA2 OBE, United Kingdom

Location

Wishaw General Hospital

Wishaw, Scotland, ML2 0DP, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33270906 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Prostatic Neoplasms

Interventions

Docetaxel; Prednisolone; Zoledronic Acid; strontium chloride

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nicholas D. James, MD

  University Hospital Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 6, 2007
• First Posted: November 7, 2007
• Study Start: February 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2013
• Last Updated: August 7, 2013

Record last verified: 2008-04

Locations

GB (16)