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Sponsored by: |
Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00541047 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy, such as goserelin, leuprolide, or bicalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy together with androgen deprivation therapy may kill more prostate cancer cells.
PURPOSE: This randomized phase III trial is studying how well giving radiation therapy together with androgen deprivation therapy works in treating patients who have undergone surgery for prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Prostate Cancer |
Drug: bicalutamide Drug: goserelin Drug: leuprolide acetate Procedure: adjuvant therapy Procedure: quality-of-life assessment Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery |
Estimated Enrollment: | 6100 |
Study Start Date: | October 2007 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients requiring immediate radiotherapy (RT) are assigned to arm I; patients do not require immediate RT are assigned to arm II. Patients for whom the need of immediate post-operative radiotherapy are uncertain undergo radiotherapy timing randomization within 3 months after surgery and are randomized to 1 of 2 radiotherapy arms.
Patients undergoing immediate RT and patients who eventually need early salvage RT undergo hormone therapy duration randomization before the administration of post-operative radiotherapy. Patients are randomized to 1 of 3 hormone therapy arms.
NOTE: *For Canadian patients, hormonal therapy will consist of LHRH analog (leuprolide acetate) therapy only.
Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed using self-administered questionnaires at baseline and 1, 5, and 10 years after randomization. Health economics information is also collected via patient-administered questionnaires (EQ-5D) at baseline and at 1, 5 and 10 years after randomization.
After completion of study treatment, patients are followed for 7 years.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Must have undergone radical prostatectomy
Exclusion criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
United Kingdom, England | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 2QQ | |
Contact: Helen Patterson, MD 44-122324-5151 ext. 2523 and 2 | |
Bristol Haematology and Oncology Centre | Recruiting |
Bristol, England, United Kingdom, BS2 8ED | |
Contact: Amit Bahl, MD 44-117-928-2468 amit.bahl@ubht.nhs.uk | |
Cancer Care Centre at York Hospital | Recruiting |
York, England, United Kingdom, Y031 8HE | |
Contact: M. Stower 44-1904-725-972 | |
Christie Hospital | Recruiting |
Manchester, England, United Kingdom, M20 4BX | |
Contact: John Logue 44-161-446-3407 john.logue@christie-tr.nwest.nhs.uk | |
Dorset County Hospital | Recruiting |
Dorchester, England, United Kingdom, DT1 2JY | |
Contact: Adrian Crellin, FRCP, FRCR 44-1305-251-150 | |
Hillingdon Hospital | Recruiting |
Uxbridge, England, United Kingdom, UB8 3NN | |
Contact: Alvan J. Pope 44-1895-238-282 | |
Mid Cheshire Hospitals Trust- Leighton Hopsital | Recruiting |
Crewe, England, United Kingdom, CW1 4QJ | |
Contact: J. P. Logue, MD 44-1270-255-141 | |
Leeds Cancer Centre at St. James's University Hospital | Recruiting |
Leeds, England, United Kingdom, LS9 7TF | |
Contact: Contact Person 44-113-206-7822 | |
Lincoln County Hospital | Recruiting |
Lincoln, England, United Kingdom, LN2 5QY | |
Contact: Thiagarajan Sreenivasant 44-1522-573-965 | |
Maidstone Hospital | Recruiting |
Maidstone, England, United Kingdom, ME16 9QQ | |
Contact: Sharon Beesley 44-1622-729-000 | |
Mayday University Hospital | Recruiting |
Croydon, England, United Kingdom | |
Contact: Contact Person 44-20-8725-3305 | |
Hope Hospital | Recruiting |
Salford, England, United Kingdom, M6 8HD | |
Contact: Noel Clarke 44-161-206-5568 | |
Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting |
Northwood, England, United Kingdom, HA6 2RN | |
Contact: Peter Ostler, MD 44-1923-844-592 | |
Royal Marsden - Surrey | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: Christopher Parker, MD 44-208-661-3425 | |
Southampton General Hospital | Recruiting |
Southampton, England, United Kingdom, SO16 6YD | |
Contact: Catherine Heath 44-23-8079-4202 | |
St. Luke's Cancer Centre at Royal Surrey County Hospital | Recruiting |
Guildford, England, United Kingdom, GU2 7XX | |
Contact: Contact Person 44-1483-406-823 | |
Stepping Hill Hospital | Recruiting |
Stockport, England, United Kingdom, SK2 7JE | |
Contact: John Logue 44-161-419-5883 | |
Torbay Hospital | Recruiting |
Torquay, England, United Kingdom, TQ2 7AA | |
Contact: Anna Lydon, MD 44-1803-655-376 | |
University College Hospital | Recruiting |
London, England, United Kingdom, NW1 2BU | |
Contact: Contact Person 44-20-7380-9105 | |
Walsgrave Hospital | Recruiting |
Coventry, England, United Kingdom, CV2 2DX | |
Contact: Contact Person 44-24-7696-7488 | |
United Kingdom, Scotland | |
Pinderfields General Hospital | Recruiting |
Wakefield, Scotland, United Kingdom, WF1 4DG | |
Contact: Contact Person 44-113-206-7822 | |
United Kingdom, Wales | |
Royal Gwent Hospital | Recruiting |
Newport Gwent, Wales, United Kingdom, NP9 2UB | |
Contact: Contact Person 44-1633-234-975 | |
University Hospital of Wales | Recruiting |
Cardiff, Wales, United Kingdom, CF14 4XW | |
Contact: Howard Kynaston 44-2920-745-094 | |
Velindre Cancer Center at Velindre Hospital | Recruiting |
Cardiff, Wales, United Kingdom, CF14 2TL | |
Contact: John Staffurth, MD 44-292-061-5888 ext. 6353 |
Study Chair: | Christopher Parker, MD | Royal Marsden - Surrey |
Study ID Numbers: | CDR0000571528, MRC-RADICALS-PR10, ISRCTN40814031, EUDRACT-2006-000205-34, EU-20767, CAN-NCIC-CTG-PR13 |
Study First Received: | October 5, 2007 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00541047 |
Health Authority: | Unspecified |
sexual dysfunction and infertility urinary complications gastrointestinal complications adenocarcinoma of the prostate |
stage I prostate cancer stage II prostate cancer stage III prostate cancer |
Infertility Prostatic Diseases Genital Neoplasms, Male Leuprolide Goserelin |
Bicalutamide Urogenital Neoplasms Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Pharmacologic Actions |
Neoplasms Androgen Antagonists Neoplasms by Site Therapeutic Uses Fertility Agents, Female Fertility Agents |