Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS)
Basic Trial Information
|Phase III||Treatment||Active||Any age||Other||CDR0000571528|
MRC-RADICALS-PR10, ISRCTN40814031, EUDRACT-2006-000205-34, EU-20767, PR13, 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.
Further Study Information
- 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.
- 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)
- Known distant metastases from prostate cancer
- PSA > 5 ng/mL at the time of hormone randomization (for patients undergoing hormone therapy duration randomization)
- No other active malignancy likely to interfere with protocol treatment or follow-up
PRIOR CONCURRENT THERAPY:
- 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
- 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
British Columbia Cancer Agency - Centre for the Southern Interior
British Columbia Cancer Agency - Vancouver Cancer Centre
London Regional Cancer Program at London Health Sciences Centre
Ottawa Health Research Institute
Princess Margaret Hospital
William Harvey Hospital
North Devon District Hospital
Basingstoke and North Hampshire NHS Foundation Trust
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Royal Bournemouth Hospital
Bradford Royal Infirmary
Bristol Haematology and Oncology Centre
Amit Bahl, MD
Helen Patterson, MD
Ph: 44-122324-5151 ext. 2523 and 2
Kent and Canterbury Hospital
Mid Cheshire Hospitals Trust- Leighton Hopsital
J. P. Logue, MD
Mayday University Hospital
Doncaster Royal Infirmary
Dorset County Hospital
Adrian Crellin, FRCP, FRCR
Princess Alexandra Hospital
Royal Devon and Exeter Hospital
St. Luke's Cancer Centre at Royal Surrey County Hospital
Leeds Cancer Centre at St. James's University Hospital
Lincoln County Hospital
Helen Rollason Cancer Care Centre at North Middlesex Hospital
Royal Marsden - London
University College Hospital
Clatterbridge Centre for Oncology
James Cook University Hospital
Mount Vernon Cancer Centre at Mount Vernon Hospital
Peter Ostler, MD
Dorset Cancer Centre
Rotherham General Hospital
Cancer Research Centre at Weston Park Hospital
Southampton General Hospital
Stepping Hill Hospital
University Hospital of North Staffordshire
Royal Marsden - Surrey
Christopher Parker, MD
Anna Lydon, MD
Alvan J. Pope
Southend University Hospital NHS Foundation Trust
Cancer Care Centre at York Hospital
Aberdeen Royal Infirmary
Edinburgh Cancer Centre at Western General Hospital
Beatson West of Scotland Cancer Centre
Pinderfields General Hospital
University Hospital of Wales
Velindre Cancer Center at Velindre Hospital
John Staffurth, MD
Ph: 44-292-061-5888 ext. 6353
Royal Gwent Hospital
Glan Clwyd Hospital
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.