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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

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 ParkerStudy 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 Identifer NCT00541047
ClinicalTrials.gov processed this data on October 17, 2013

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.

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