Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS)

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActiveAny ageOtherCDR0000571528
MRC-RADICALS-PR10, ISRCTN40814031, EUDRACT-2006-000205-34, EU-20767, PR13, NCT00541047

Trial Description

Summary

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.

Further Study Information

OBJECTIVES:

  • Assess the timing of radiotherapy and the use of hormone therapy in conjunction with post-operative radiotherapy.
  • Determine the impact of radiotherapy on general quality of life, sexual function, urinary function, and bowel function.
  • Determine the impact of duration of hormone therapy on general quality of life and sexual function.

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.

  • Arm I (immediate RT): Within 2 months after randomization, patients undergo radiotherapy to the prostate bed once a day, 5 days a week, for 4 (20 fractions total) or 6.5 weeks (33 fractions total). They may also undergo radiotherapy to the pelvic lymph nodes once a day, 5 days a week, for 4.5 weeks (23 fractions total) at the investigator's discretion.
  • Arm II (early salvage RT in case of PSA failure): Within 2 months of confirmation of post-operative biochemical failure, patients undergo radiotherapy as in arm I.

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.

  • Arm III (no hormone therapy): Patients do not receive hormone therapy. They receive post-operative RT alone as described above in arm I or II.
  • Arm IV (RT and short-term hormone therapy): Beginning approximately 2 months prior to the start of RT, patients receive hormone therapy for 6 months. Hormone therapy* may comprise of LHRH agonist (gonadotrophin-releasing hormone analogue [GnRHa] [e.g., goserelin or leuprolide acetate]) or bicalutamide daily.
  • Arm V (RT and long-term hormone therapy): Beginning approximately 2 months prior to the start of RT, patients receive hormone therapy for 24 months. Hormone therapy* may comprise of LHRH agonist (gonadotrophin-releasing hormone analogue [GnRHa] [e.g., goserelin or leuprolide acetate]) or bicalutamide daily.

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Diagnosis of nonmetastatic adenocarcinoma of the prostate
  • Must have undergone radical prostatectomy
  • Post-operative serum prostate-specific antigen (PSA) < 0.4 ng/mL
  • No post-operative biochemical failure, defined as EITHER two consecutive rises in PSA and final PSA > 0.1 ng/mL OR three consecutive rises in PSA (for patients undergoing hormone therapy duration randomization)

Exclusion criteria:

  • Known distant metastases from prostate cancer
  • PSA > 5 ng/mL at the time of hormone randomization (for patients undergoing hormone therapy duration randomization)

PATIENT CHARACTERISTICS:

  • No other active malignancy likely to interfere with protocol treatment or follow-up

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • See Disease Characteristics
  • Co-enrollment to other trials is permitted, providing this does not interfere with the outcome measures
  • 5-α reductase inhibitors, soya, selenium, and vitamin E are acceptable non-trial therapies

Exclusion criteria:

  • Prior hormone therapy
  • Bilateral orchidectomy
  • Prior pelvic radiotherapy
  • Neoadjuvant treatment
  • Other concurrent therapies for prostate cancer (e.g., estrogens or cytotoxic chemotherapy) prior to disease progression

Trial Contact Information

Trial Lead Organizations/Sponsors

Medical Research Council's Working Party on Leukemia in Adults and Children

    Christopher Parker, Study Chair

    Trial Sites

    Canada

    British Columbia
    Kelowna

    British Columbia Cancer Agency - Centre for the Southern Interior

    Contact Person
    Ph: 250-712-3900

    Vancouver

    British Columbia Cancer Agency - Vancouver Cancer Centre

    Contact Person
    Ph: 604-877-6000

    Ontario
    London

    London Regional Cancer Program at London Health Sciences Centre

    Contact Person
    Ph: 519-685-8615

    Ottawa

    Ottawa Health Research Institute

    Contact Person
    Ph: 613-761-4395

    Toronto

    Princess Margaret Hospital

    Contact Person
    Ph: 416-946-2811

    United Kingdom

    England
    Ashford-Kent

    William Harvey Hospital

    Contact Person
    Ph: 44-1227-766-877

    Barnstaple

    North Devon District Hospital

    Contact Person
    Ph: 44-1392-402-114

    Basingstoke

    Basingstoke and North Hampshire NHS Foundation Trust

    Contact Person
    Ph: 44-1483-406-823

    Birmingham

    Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Contact Person
    Ph: 44-121-472-1311

    Bournemouth

    Royal Bournemouth Hospital

    Contact Person
    Ph: 44-1202-448-435

    Bradford

    Bradford Royal Infirmary

    Contact Person
    Ph: 44-113-206-7630

    Bristol

    Bristol Haematology and Oncology Centre

    Amit Bahl, MD
    Ph: 44-117-928-2468
    Email: amit.bahl@ubht.nhs.uk

    Southmead Hospital

    Contact Person
    Ph: 44-117-959-5147

    Cambridge

    Addenbrooke's Hospital

    Helen Patterson, MD
    Ph: 44-122324-5151 ext. 2523 and 2

    Canterbury

    Kent and Canterbury Hospital

    Contact Person
    Ph: 44-1227-766-877

    Coventry

    Walsgrave Hospital

    Contact Person
    Ph: 44-24-7696-7488

    Crewe

    Mid Cheshire Hospitals Trust- Leighton Hopsital

    J. P. Logue, MD
    Ph: 44-1270-255-141

    Croydon

    Mayday University Hospital

    Contact Person
    Ph: 44-20-8725-3305

    Doncaster

    Doncaster Royal Infirmary

    Contact Person
    Ph: 44-114-226-5000

    Dorchester

    Dorset County Hospital

    Adrian Crellin, FRCP, FRCR
    Ph: 44-1305-251-150

    Essex

    Princess Alexandra Hospital

    Contact Person
    Ph: 44-20-887-2687

    Exeter

    Royal Devon and Exeter Hospital

    Contact Person
    Ph: 44-1392-402-105

    Guildford

    St. Luke's Cancer Centre at Royal Surrey County Hospital

    Contact Person
    Ph: 44-1483-406-823

    Ipswich

    Ipswich Hospital

    Contact Person
    Ph: 44-1473-704-389

    Leeds

    Leeds Cancer Centre at St. James's University Hospital

    Contact Person
    Ph: 44-113-206-7822

    Lincoln

    Lincoln County Hospital

    Contact Person
    Ph: 44-1522-572-215

    London

    Guy's Hospital

    Contact Person
    Ph: 44-20-7188-4219

    Helen Rollason Cancer Care Centre at North Middlesex Hospital

    Contact Person
    Ph: 44-20-887-2687

    Royal Marsden - London

    Contact Person
    Ph: 44-20-7808-2788

    University College Hospital

    Contact Person
    Ph: 44-20-7380-9105

    Maidstone

    Maidstone Hospital

    Sharon Beesley
    Ph: 44-1622-729-000

    Manchester

    Christie Hospital

    John Logue
    Ph: 44-161-446-3407
    Email: john.logue@christie-tr.nwest.nhs.uk

    Merseyside

    Clatterbridge Centre for Oncology

    Contact Person
    Ph: 44-151-334-1155

    Middlesbrough

    James Cook University Hospital

    Contact Person
    Ph: 44-1642-850-830

    Northwood

    Mount Vernon Cancer Centre at Mount Vernon Hospital

    Peter Ostler, MD
    Ph: 44-1923-844-592

    Plymouth

    Derriford Hospital

    Contact Person
    Ph: 44-1752-517-809

    Poole Dorset

    Dorset Cancer Centre

    Contact Person
    Ph: 44-1202-448-263

    Romford

    Queen's Hospital

    Contact Person
    Ph: 44-1708-435-428

    Rotherham

    Rotherham General Hospital

    Contact Person
    Ph: 44-114-226-5000

    Salford

    Hope Hospital

    Noel Clarke
    Ph: 44-161-206-5568

    Sheffield

    Cancer Research Centre at Weston Park Hospital

    Contact Person
    Ph: 44-114-226-5000

    Southampton

    Southampton General Hospital

    Catherine Heath
    Ph: 44-23-8079-4202

    Stockport

    Stepping Hill Hospital

    John Logue
    Ph: 44-161-419-5883

    Stoke-On-Trent

    University Hospital of North Staffordshire

    Contact Person
    Ph: 44-1782-554-301

    Sutton

    Royal Marsden - Surrey

    Christopher Parker, MD
    Ph: 44-208-661-3425

    Torquay

    Torbay Hospital

    Anna Lydon, MD
    Ph: 44-1803-655-376

    Uxbridge

    Hillingdon Hospital

    Alvan J. Pope
    Ph: 44-1895-238-282

    Westcliff-On-Sea

    Southend University Hospital NHS Foundation Trust

    Contact Person
    Ph: 44-1702-435-555

    York

    Cancer Care Centre at York Hospital

    M. Stower
    Ph: 44-1904-725-972

    Scotland
    Aberdeen

    Aberdeen Royal Infirmary

    Contact Person
    Ph: 44-1224-551-273

    Ayr

    Ayr Hospital

    Contact Person
    Ph: 44-141-301-7062

    Edinburgh

    Edinburgh Cancer Centre at Western General Hospital

    Contact Person
    Ph: 44-131-537-3036

    Glasgow

    Beatson West of Scotland Cancer Centre

    Contact Person
    Ph: 44-141-301-7062

    Wakefield

    Pinderfields General Hospital

    Contact Person
    Ph: 44-113-206-7822

    Wales
    Cardiff

    University Hospital of Wales

    Howard Kynaston
    Ph: 44-2920-745-094

    Velindre Cancer Center at Velindre Hospital

    John Staffurth, MD
    Ph: 44-292-061-5888 ext. 6353

    Newport Gwent

    Royal Gwent Hospital

    Contact Person
    Ph: 44-1633-234-975

    Rhyl, Denbighshire

    Glan Clwyd Hospital

    Contact Person
    Ph: 44-1745-445-158

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00541047
    ClinicalTrials.gov processed this data on April 09, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.