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Spots Global Cancer Trial Database for RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery

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Trial Identification

Brief Title: RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery

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

Study ID: NCT00541047

Study Description

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.

Eligibility

Minimum Age: 0 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, Canada

British Columbia Cancer Agency - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada

Ottawa Health Research Institute, Ottawa, Ontario, Canada

Princess Margaret Hospital, Toronto, Ontario, Canada

William Harvey Hospital, Ashford, England, United Kingdom

North Devon District Hospital, Barnstaple, England, United Kingdom

Basingstoke and North Hampshire NHS Foundation Trust, Basingstoke, England, United Kingdom

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham, England, United Kingdom

Royal Bournemouth Hospital, Bournemouth, England, United Kingdom

Bradford Royal Infirmary, Bradford, England, United Kingdom

Southmead Hospital, Bristol, England, United Kingdom

Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom

Addenbrooke's Hospital, Cambridge, England, United Kingdom

Kent and Canterbury Hospital, Canterbury, England, United Kingdom

Walsgrave Hospital, Coventry, England, United Kingdom

Mid Cheshire Hospitals Trust- Leighton Hopsital, Crewe, England, United Kingdom

Mayday University Hospital, Croydon, England, United Kingdom

Doncaster Royal Infirmary, Doncaster, England, United Kingdom

Dorset County Hospital, Dorchester, England, United Kingdom

Royal Devon and Exeter Hospital, Exeter, England, United Kingdom

St. Luke's Cancer Centre at Royal Surrey County Hospital, Guildford, England, United Kingdom

Princess Alexandra Hospital, Harlow, England, United Kingdom

Ipswich Hospital, Ipswich, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

Lincoln County Hospital, Lincoln, England, United Kingdom

Helen Rollason Cancer Care Centre at North Middlesex Hospital, London, England, United Kingdom

University College Hospital, London, England, United Kingdom

Guy's Hospital, London, England, United Kingdom

Royal Marsden - London, London, England, United Kingdom

Maidstone Hospital, Maidstone, England, United Kingdom

Clatterbridge Centre for Oncology, Manchester, 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

Rotherham General Hospital, Rotherham, England, United Kingdom

Hope Hospital, Salford, England, United Kingdom

Cancer Research Centre at Weston Park Hospital, Sheffield, England, United Kingdom

Southampton General Hospital, Southampton, England, United Kingdom

Stepping Hill Hospital, Stockport, England, United Kingdom

University Hospital of North Staffordshire, Stoke-On-Trent, England, United Kingdom

Royal Marsden - Surrey, Sutton, England, United Kingdom

Torbay Hospital, Torquay, England, United Kingdom

Hillingdon Hospital, Uxbridge, England, United Kingdom

Southend University Hospital NHS Foundation Trust, Westcliff-On-Sea, England, United Kingdom

Cancer Care Centre at York Hospital, York, England, United Kingdom

Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom

Ayr Hospital, Ayr, Scotland, United Kingdom

Edinburgh Cancer Centre at Western General Hospital, Edinburgh, Scotland, United Kingdom

Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom

Pinderfields General Hospital, Wakefield, Scotland, United Kingdom

Glan Clwyd Hospital, Bodelwyddan, Wales, United Kingdom

Velindre Cancer Center at Velindre Hospital, Cardiff, Wales, United Kingdom

University Hospital of Wales, Cardiff, Wales, United Kingdom

Royal Gwent Hospital, Newport, Wales, United Kingdom

Contact Details

Name: Christopher Parker, MD

Affiliation: Royal Marsden NHS Foundation Trust

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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