RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery
- Conditions
- Gastrointestinal ComplicationsProstate CancerSexual DysfunctionUrinary Complications
- Interventions
- Procedure: adjuvant therapyProcedure: quality-of-life assessmentRadiation: radiation therapy
- Registration Number
- NCT00541047
- Lead Sponsor
- University College, London
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 4236
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description RADICALS-RT: Early RT adjuvant therapy - RADICALS-RT: Early RT quality-of-life assessment - RADICALS-RT: Early RT radiation therapy - RADICALS-RT: Salvage RT adjuvant therapy - RADICALS-RT: Salvage RT quality-of-life assessment - RADICALS-RT: Salvage RT radiation therapy - RADICALS-HD: Radiotherapy Alone adjuvant therapy - RADICALS-HD: Radiotherapy Alone radiation therapy - RADICALS-HD: Radiotherapy + 6 months goserelin acetate - RADICALS-HD: Radiotherapy + 6 months leuprolide acetate - RADICALS-HD: Radiotherapy + 6 months adjuvant therapy - RADICALS-HD: Radiotherapy + 6 months radiation therapy - RADICALS-HD: Radiotherapy + 24 months goserelin acetate - RADICALS-HD: Radiotherapy + 24 months leuprolide acetate - RADICALS-HD: Radiotherapy + 24 months adjuvant therapy - RADICALS-HD: Radiotherapy + 24 months radiation therapy - RADICALS-HD: Radiotherapy + 6 months bicalutamide - RADICALS-HD: Radiotherapy + 24 months bicalutamide -
- Primary Outcome Measures
Name Time Method Disease-specific survival (i.e., death due to prostate cancer) (RADICALS-HD) up 12 years Freedom from distant metastases (any distance metastases or prostate cancer death) (RADICALS-RT) up 12 years
- Secondary Outcome Measures
Name Time Method Patient reported outcomes - EQ5D up 12 years Treatment toxicity up 12 years Freedom from treatment failure up 12 years Clinical progression-free survival up 12 years Overall survival up 12 years Freedom from biochemical progression (RADICALS-RT) up 12 years Non-protocol hormone therapy up 12 years
Trial Locations
- Locations (58)
London Regional Cancer Program at London Health Sciences Centre
🇨🇦London, Ontario, Canada
Ottawa Health Research Institute
🇨🇦Ottawa, Ontario, Canada
Lincoln County Hospital
🇬🇧Lincoln, England, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
🇬🇧Basingstoke, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Southmead Hospital
🇬🇧Bristol, England, United Kingdom
Doncaster Royal Infirmary
🇬🇧Doncaster, England, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Royal Marsden - London
🇬🇧London, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Dorset Cancer Centre
🇬🇧Poole Dorset, England, United Kingdom
Queen's Hospital
🇬🇧Romford, England, United Kingdom
Hope Hospital
🇬🇧Salford, England, United Kingdom
Stepping Hill Hospital
🇬🇧Stockport, England, United Kingdom
University Hospital of North Staffordshire
🇬🇧Stoke-On-Trent, England, United Kingdom
Torbay Hospital
🇬🇧Torquay, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Cancer Care Centre at York Hospital
🇬🇧York, England, United Kingdom
Hillingdon Hospital
🇬🇧Uxbridge, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Ayr Hospital
🇬🇧Ayr, Scotland, United Kingdom
Glan Clwyd Hospital
🇬🇧Bodelwyddan, Wales, United Kingdom
Pinderfields General Hospital
🇬🇧Wakefield, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Royal Gwent Hospital
🇬🇧Newport, Wales, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, England, United Kingdom
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Princess Alexandra Hospital
🇬🇧Harlow, England, United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
🇬🇧Birmingham, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
William Harvey Hospital
🇬🇧Ashford, England, United Kingdom
University College Hospital
🇬🇧London, England, United Kingdom
Mid Cheshire Hospitals Trust- Leighton Hopsital
🇬🇧Crewe, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
British Columbia Cancer Agency - Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
Clatterbridge Centre for Oncology
🇬🇧Manchester, England, United Kingdom
North Devon District Hospital
🇬🇧Barnstaple, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
British Columbia Cancer Agency - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Rotherham General Hospital
🇬🇧Rotherham, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Helen Rollason Cancer Care Centre at North Middlesex Hospital
🇬🇧London, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Mayday University Hospital
🇬🇧Croydon, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Guy's Hospital
🇬🇧London, England, United Kingdom