STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial

This study is currently recruiting participants.
Verified February 2013 by Medical Research Council
Sponsor:
Information provided by (Responsible Party):
Medical Research Council
ClinicalTrials.gov Identifier:
NCT00268476
First received: December 20, 2005
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

Prostate cancers depend upon the male hormone testosterone for their growth. Lowering testosterone levels (either by removing all or part of both testes, or by giving anti-hormone treatment) slows the growth of prostate cancers. This type of treatment is called hormone treatment and is often used when prostate cancers have spread outside of the prostate gland. Although hormone treatment is usually successful at stopping the cancer growing for a period of time, the cancer will begin to grow again in most men.

There are increasing numbers of treatments available for advanced prostate cancer. These treatments are usually used in prostate cancer when hormone treatment is no longer effective and the cancer has started to grow again. The aim of this trial, which is called STAMPEDE, is to assess five of these treatments, given earlier in the course of the disease in combination with hormone treatment.

The treatments assessed during the trial are:

  1. Zoledronic acid: Prostate cancer cells can spread to bones and weaken them. Zoledronic acid is a drug that reduces bone destruction and hardens bones. This may make them more resistant to attack by cancer cells.
  2. Docetaxel: A drug that stops cells replicating, Docetaxel is currently being used to treat a range of cancers including lung, breast and ovarian cancer as well as prostate cancer. Docetaxel is already known to prolong survival in men with relapsed metastatic prostate cancer.
  3. Celecoxib: An aspirin-like drug that is used to treat arthritis. Celecoxib slows down the growth of cancer cells in the laboratory. We wished to see if it had the same effect on cancer cells in patients. Recruitment to new patients for the evaluation of this drug is finished as a pre-planned interim analysis failed to demonstrate sufficient activity.
  4. Abiraterone (included from protocol version 8.0): An inhibitor of steroid hormone synthesis that blocks prostate cancer cells from generating their own male hormones. This is thought to be a major way in which prostate cancer cells resume growth following castration based therapies. This agent is given along with prednisolone and is already known to prolong survival when given to men following failure of docetaxel chemotherapy.
  5. Prostate radiotherapy (included from protocol version 9.0): Treatment with high-energy x-rays targeted to the prostate gland. This treatment is now mandatory for patients with cancer that is confined to the prostate gland as large trials have shown it improves survival times. We are interested in whether we should give radiotherapy to the prostate if the cancer has already spread.

STAMPEDE will look at the effect of combining one or two of the treatments described above with hormone treatment. A computer program will be used to allocate which treatment the patient receives, using a chance process. The trial will look at the effects of the combined treatments on quality of life and find out whether the new treatment combinations increase the time when the cancer is not growing and ultimately results in patients living longer. The study will also look at which treatment provides the greater value for money for the health service. More than 5,000 patients will join the trial with answers becoming available over 7 to 12 years.


Condition Intervention Phase
Prostate Cancer
Drug: celecoxib
Drug: docetaxel
Drug: prednisolone
Drug: releasing hormone agonist therapy
Drug: zoledronic acid
Drug: abiraterone
Procedure: orchiectomy
Radiation: Radiotherapy to the prostate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: STAMPEDE: Systemic Therapy in Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy - Androgen Suppression-Based Therapy Alone or Combined With Zoledronic Acid, Docetaxel, Prednisolone, Celecoxib, Abiraterone and/or Radiotherapy in Treating Patients With Locally Advanced or Metastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Medical Research Council:

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Failure-free survival [ Designated as safety issue: No ]
  • Cost effectiveness by EuroQol [ Designated as safety issue: No ]
  • Quality of life (QOL) by EORTC QOL Questionnaire C30 and prostate specific 25-item [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Skeletal related events [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: September 2005
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A Androgen Deprivation Therapy [ADT]
(plus Radiotherapy for newly-diagnosed non-metastatic disease)[Control]
Drug: releasing hormone agonist therapy Procedure: orchiectomy
Experimental: Arm B (ADT + zoledronic acid) Drug: releasing hormone agonist therapy Drug: zoledronic acid Procedure: orchiectomy
Experimental: Arm C (ADT + docetaxel + prednisolone) Drug: docetaxel Drug: prednisolone Drug: releasing hormone agonist therapy Procedure: orchiectomy
Experimental: Arm D (ADT + celecoxib) NO LONGER RECRUITING Drug: docetaxel Drug: prednisolone Drug: releasing hormone agonist therapy Drug: zoledronic acid Procedure: orchiectomy
Experimental: Arm E (ADT + zoledronic acid + docetaxel + prednisolone) Drug: releasing hormone agonist therapy Drug: abiraterone Procedure: orchiectomy
Experimental: Arm F (ADT + zoledronic acid + celecoxib) NO LONGER RECRUITING Drug: celecoxib Drug: releasing hormone agonist therapy Procedure: orchiectomy
Experimental: Arm G (ADT + abiraterone) Drug: celecoxib Drug: releasing hormone agonist therapy Procedure: orchiectomy
Experimental: Arm H (ADT + radiotherapy to the prostate) Drug: releasing hormone agonist therapy Procedure: orchiectomy Radiation: Radiotherapy to the prostate

Detailed Description:

OBJECTIVES:

Primary

  • Compare the safety of Androgen Deprivation Therapy (ADT) alone vs ADT in varying combinations with zoledronic acid, docetaxel, abiraterone and/or radiotherapy to the prostate (and previously celecoxib) in patients with locally advanced or metastatic prostate cancer.
  • Compare failure-free survival and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, controlled, multicenter, pilot study. Patients are randomized to 1 of 6 treatment arms.

  • Arm A (Androgen Deprivation Therapy [ADT] (plus RT for newly-diagnosed non-metastatic disease) [control]): Patients undergo bilateral orchidectomy or receive luteinizing hormone-releasing hormone (LHRH) analogues to achieve castration levels of testosterone.
  • Arm B (ADT and zoledronic acid): Patients undergo ADT (+/- RT) as in arm A. Patients also receive zoledronic acid IV over 15 minutes on day 1. Treatment repeats every 3 weeks for 6 courses and then every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
  • Arm C (ADT, docetaxel, and prednisolone): Patients undergo ADT (+/- RT) as in arm A. Patients also receive docetaxel IV over 1 hour on day 1 and oral prednisolone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm D (ADT and celecoxib): Patients undergo ADT as in arm A. Patients also receive oral celecoxib twice daily for 1 year in the absence of disease progression or unacceptable toxicity (no longer recruiting).
  • Arm E (ADT, zoledronic acid, docetaxel, and prednisolone): Patients undergo ADT (+/- RT) as in arm A. Patients also receive zoledronic acid as in arm B and docetaxel and prednisolone as in arm C.
  • Arm F (ADT, zoledronic acid, and celecoxib): Patients undergo ADT as in arm A. Patients also receive zoledronic acid as in arm B and celecoxib as in arm D (no longer recruiting).
  • Arm G (ADT and abiraterone): Patients undergo ADT (+/- RT) as in arm A. Patients also receive oral abiraterone once daily together with prednisolone or prednisone 5mg daily to prevent secondary ACTH excess.
  • Arm H (ADT and radiotherapy to the prostate): Patients (newly-diagnosed-metastatic only) undergo ADT, as in arm A. Patients also receive radiotherapy to the prostate. Two radiotherapy dose-fractionation schedules are permitted. In either case, radiotherapy is prescribed such that at least 95% of the PTV receives the prescribed dose:

    36Gy in 6 fractions of 6Gy, administered weekly over 6 consecutive weeks or 55Gy in 20 fractions of 2.75Gy, administered daily, five days per week, over 4 consecutive weeks.

After completion of study treatment, patients are followed periodically thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK. Grant funding: Novartis, Sanofi-Aventis, Pfizer, Janssen. Core funding: Medical Research Council PROJECTED ACCRUAL: Approximately 5000 patients will be accrued for this study

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

HIGH-RISK NEWLY DIAGNOSED NON-METASTATIC NODE-NEGATIVE DISEASE

Both:

At least two of:

  • Stage T3/4, PSA≥40ng/ml or Gleason sum score 8-10
  • Intention to treat with radical radiotherapy (unless there is a contra-indication; exemption can sought in advance of consent, after discussion with MRC CTU)

OR NEWLY DIAGNOSED METASTATIC OR NODE-POSITIVE DISEASE

At least one of:

  • Stage Tany N+ M0
  • Stage Tany Nany M+

OR PREVIOUSLY TREATED WITH RADICAL SURGERY AND/OR RADIOTHERAPY, NOW RELAPSING1

At least one of:

  • PSA ≥4ng/ml and rising with doubling time less than 6 months
  • PSA ≥20ng/ml
  • N+
  • M+

AND FOR ALL PATIENTS I. Histologically confirmed prostate adenocarcinoma II. Intention to treat with long-term androgen deprivation therapy III. Fit for all protocol treatment2 and follow-up, WHO performance status 0-23 IV. Have completed the appropriate investigations prior to randomisation V. Adequate haematological function: neutrophil count >1.5x109/l and platelets >100x109/l VI. Estimated creatinine clearance >30ml/min VII. Serum potassium ≥3.5mmol/L VIII. Written informed consent IX. Willing and expected to comply with follow-up schedule X. Using effective contraceptive method if applicable

PATIENT EXCLUSION CRITERIA Patients must not fulfil any of the criteria, below. I. Prior systemic therapy for locally advanced or metastatic prostate cancer except as listed in Section 4.1.3 of the protocol.

II. Metastatic brain disease or leptomeningeal disease

III. Abnormal liver functions consisting of any of the following:

Serum bilirubin ≥1.5 x ULN (except for patients with Gilbert's disease, for whom the upper limit of serum bilirubin is 51.3μmol/l or 3mg/dl) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN IV. Any other previous or current malignant disease which, in the judgement of the responsible physician, is likely to interfere with STAMPEDE treatment or assessment V. Patients with active peptic ulceration, gastrointestinal bleeding, inflammatory bowel disease VI. Symptomatic peripheral neuropathy grade <2 (NCI CTC)5 VII. Any surgery (e.g. TURP) performed within the past 4 weeks

VIII. Patients with significant cardiovascular disease such that, in the investigator's opinion, the patient is unfit for any of the study treatments. This might include:

  • Severe/unstable angina
  • Myocardial infarction less than 6 months prior to randomisation
  • Arterial thrombotic events less than 6 months prior to randomisation
  • Clinically significant cardiac failure requiring treatment (NYHA II-IV)6
  • Cerebrovascular disease (e.g. stroke or transient ischaemic episode) less than 2 years prior to randomisation
  • Patients with uncontrolled hypertension defined as systolic BP greater or equal than 160 mmHg or diastolic BP greater or equal than 95 mmHg IX. Patients who have been scheduled to have major dental extractions within the next 2 years X. Patients receiving treatment with drugs known to induce CYP3A4 (including phenytoin, carbamazepine, Phenobarbital)7 XI. Prior exposure to abiraterone XII. Prior chemotherapy for prostate cancer XIII. Prior therapy with zoledronic acid other than short-term treatment for hypercalcaemia XIV. Prior exposure to policy of long-term hormone therapy before randomisation (unless as described in Section 4.4.2 of the protocol)

SELECTION CRITERIA FOR COMPARISON OF RESEARCH (M1) RT FOR METASTATIC DISEASE

All patients meeting criteria above are eligible for the trial, but not all can be allocated to the research (M1) radiotherapy arm. The selection criteria for this "RT to the prostate" comparison are:

  • Newly diagnosed prostate cancer
  • Demonstrable M1 disease
  • No contraindication to radiotherapy e.g. no previous pelvic radiotherapy,
  • No previous radical prostatectomy

Patients meeting these criteria will have a chance to be allocated to Arms A and H.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268476

Contacts
Contact: Francesca Schiavone +44 (0)20 7670 4632 stampede@ctu.mrc.ac.uk

  Hide Study Locations
Locations
Switzerland
Hirslanden Klinik Aarau Recruiting
Aarau, Switzerland
Universitaetsspital-Basel Recruiting
Basel, Switzerland, CH-4031
Inselspital Bern Recruiting
Bern, Switzerland
Kantonsspital Graubuenden Recruiting
Chur, Switzerland
Lausanne Centre Hospitalier Universitaire Recruiting
Lausanne, Switzerland
Liestal Hospital Recruiting
Liestal, Switzerland
Kantonsspital - St. Gallen Recruiting
St. Gallen, Switzerland
Winterthur Hospital Recruiting
Winterthur, Switzerland
City Hospital Triemli Recruiting
Zurich, Switzerland
UniversitaetsSpital Zuerich Recruiting
Zurich, Switzerland, CH-8091
United Kingdom
William Harvey Hospital Recruiting
Ashford-Kent, England, United Kingdom, TN24 0LZ
Contact: Contact Person    44-1233-633-331      
Stoke Mandeville Hospital Recruiting
Aylesbury-Buckinghamshire, England, United Kingdom, HP21 8AL
North Devon District Hospital Recruiting
Barnstaple, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust Recruiting
Basingstoke, England, United Kingdom
Royal United Hospital Recruiting
Bath, England, United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust Recruiting
Birmingham, England, United Kingdom
City Hospital (Birmingham) Recruiting
Birmingham, England, United Kingdom
Royal Bournemouth Hospital Recruiting
Bournemouth, England, United Kingdom
Bradford Royal Infirmary Recruiting
Bradford, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital Recruiting
Brighton, England, United Kingdom, BN2 5BE
Bristol Haematology and Oncology Centre Recruiting
Bristol, England, United Kingdom
Broomfield Hospital Recruiting
Broomfield, England, United Kingdom
Burnley General Hospital Recruiting
Burnley, England, United Kingdom
Queen's Hospital Recruiting
Burton-upon-Trent, England, United Kingdom
West Suffolk Hospital Recruiting
Bury St. Edmunds, England, United Kingdom, IP33 2QZ
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Canterbury, England, United Kingdom
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Carlisle, England, United Kingdom
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Cheltenham, England, United Kingdom
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Chester, England, United Kingdom
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Cosham, England, United Kingdom
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Cottingham, England, United Kingdom
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Crewe, England, United Kingdom
Darlington Memorial Recruiting
Darlington, England, United Kingdom
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Derby, England, United Kingdom
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Doncaster, England, United Kingdom
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Dorchester, England, United Kingdom
Russells Hall Hospital Recruiting
Dudley, England, United Kingdom
University Hospital of North Durham Recruiting
Durham, England, United Kingdom, DH1 5TW
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Eastbourne, England, United Kingdom
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Essex, England, United Kingdom
Royal Devon and Exeter Hospital Recruiting
Exeter, England, United Kingdom
Royal Bolton Hospital Recruiting
Farnworth, England, United Kingdom
Gloucestershire Royal Hospital Recruiting
Gloucester, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital Recruiting
Guildford, England, United Kingdom
Hereford Hospitals Recruiting
Hereford, England, United Kingdom
Wycombe General Hospital Recruiting
High Wycombe, England, United Kingdom
Huddersfield Royal Infirmary Recruiting
Huddersfield, West Yorks, England, United Kingdom
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Ipswich, England, United Kingdom
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Keighley, England, United Kingdom
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Kidderminster Worcestershire, England, United Kingdom
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Lancanshire, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom
Glenfield Hospital Recruiting
Leicester, England, United Kingdom
Royal Liverpool University Hospital Recruiting
Liverpool, England, United Kingdom
University Hospital Aintree Recruiting
Liverpool, England, United Kingdom
Helen Rollason Cancer Care Centre at North Middlesex Hospital Recruiting
London, England, United Kingdom
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London, England, United Kingdom
Charing Cross Hospital Recruiting
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London, England, United Kingdom
UCL Cancer Institute Recruiting
London, England, United Kingdom, WC1E 6DD
Guy's Hospital Recruiting
London, England, United Kingdom
University College of London Hospitals Recruiting
London, England, United Kingdom, WIT 3AA
Mid Kent Oncology Centre at Maidstone Hospital Recruiting
Maidstone, England, United Kingdom
Withington Hospital Recruiting
Manchester, England, United Kingdom, M20 8LR
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Manchester, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital Recruiting
Margate, England, United Kingdom
Clatterbridge Centre for Oncology Recruiting
Merseyside, England, United Kingdom
James Cook University Hospital Recruiting
Middlesbrough, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital Recruiting
Newcastle-Upon-Tyne, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital Recruiting
Northwood, England, United Kingdom
Nottingham City Hospital Recruiting
Nottingham, England, United Kingdom
Royal Oldham Hospital Recruiting
Oldham, England, United Kingdom
Churchill Hospital Recruiting
Oxford, England, United Kingdom
Dorset Cancer Centre Recruiting
Poole Dorset, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital Recruiting
Preston, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital Recruiting
Reading, England, United Kingdom
Queen's Hospital Recruiting
Romford, England, United Kingdom
Conquest Hospital Recruiting
Saint Leonards-on-Sea, England, United Kingdom
Hope Hospital Recruiting
Salford, England, United Kingdom
Scarborough General Hospital Recruiting
Scarborough, England, United Kingdom
Cancer Research Centre at Weston Park Hospital Recruiting
Sheffield, England, United Kingdom
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Shrewsbury, England, United Kingdom
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South Shields, England, United Kingdom
Southampton General Hospital Recruiting
Southampton, England, United Kingdom
Southport and Formby District General Hospital Recruiting
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Lister Hospital Recruiting
Stevenage, England, United Kingdom
Stepping Hill Hospital Recruiting
Stockport, England, United Kingdom, SK2 7JE
University Hospital of North Staffordshire (City General Hospital) Recruiting
Stoke-on-Trent, England, United Kingdom
Sunderland Royal Hospital Recruiting
Sunderland, England, United Kingdom, SR4 7TP
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom
King's Mill Hospital Recruiting
Sutton-in-Ashfield, England, United Kingdom
Great Western Hospital Recruiting
Swindon, England, United Kingdom
Musgrove Park Hospital Recruiting
Taunton, England, United Kingdom
Torbay Hospital Recruiting
Torquay, England, United Kingdom, TQ2 7AA
Warrington Hospital NHS Trust Recruiting
Warrington, England, United Kingdom, WA5 1QG
Southend University Hospital NHS Foundation Trust Recruiting
Westcliff-On-Sea, England, United Kingdom
Weston General Hospital Recruiting
Weston Super Mare, England, United Kingdom
West Cumberland Hospital Recruiting
Whitehaven, England, United Kingdom
Worcester Royal Hospital Recruiting
Worcester, England, United Kingdom, WR5 1DD
Worthing Hospital Recruiting
Worthing, England, United Kingdom, BN11 2DH
St. Mary's Hospital Recruiting
Newport, Isle of Wight, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast Recruiting
Belfast, Northern Ireland, United Kingdom
Ayr Hospital Recruiting
Ayr, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital Recruiting
Edinburgh, Scotland, United Kingdom
Beatson Institute for Cancer Research - Glasgow Recruiting
Glasgow, Scotland, United Kingdom
Raigmore Hospital Recruiting
Inverness, Scotland, United Kingdom
Bronglais General Hospital Recruiting
Aberystwyth, Wales, United Kingdom
Velindre Cancer Center at Velindre Hospital Recruiting
Cardiff, Wales, United Kingdom, CF14 2TL
South West Wales Cancer Institute Recruiting
Swansea, Wales, United Kingdom
Barnet and Chase Farm Hospital Recruiting
Barnet, United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom
Essex County Hospital Recruiting
Colchester, United Kingdom
Forth Valley Hospital Recruiting
Larbert, United Kingdom
Lincoln Hospital Recruiting
Lincoln, United Kingdom
North Tees Hospital Recruiting
Stockton-on-Tees, United Kingdom
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: Nicholas D. James, MD University Hospital Birmingham
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Research Council
ClinicalTrials.gov Identifier: NCT00268476     History of Changes
Other Study ID Numbers: CDR0000455008, MRC-STAMPEDE, EU-205102, MRC-PR08, ISRCTN78818544, EUDRACT-2004-000193-31
Study First Received: December 20, 2005
Last Updated: February 25, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Medical Research Council:
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Methylprednisolone acetate
Prednisolone acetate
Celecoxib
Docetaxel
Zoledronic acid
Diphosphonates
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on April 22, 2014