RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery
NCT ID: NCT00541047
Last Updated: 2023-11-13
Study Results
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Basic Information
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COMPLETED
PHASE3
4236 participants
INTERVENTIONAL
2007-11-30
2022-07-27
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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RADICALS-RT: Early RT
adjuvant therapy
quality-of-life assessment
radiation therapy
RADICALS-RT: Salvage RT
adjuvant therapy
quality-of-life assessment
radiation therapy
RADICALS-HD: Radiotherapy Alone
adjuvant therapy
radiation therapy
RADICALS-HD: Radiotherapy + 6 months
bicalutamide
goserelin acetate
leuprolide acetate
adjuvant therapy
radiation therapy
RADICALS-HD: Radiotherapy + 24 months
bicalutamide
goserelin acetate
leuprolide acetate
adjuvant therapy
radiation therapy
Interventions
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bicalutamide
goserelin acetate
leuprolide acetate
adjuvant therapy
quality-of-life assessment
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
* 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:
* 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
0 Years
120 Years
MALE
No
Sponsors
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Canadian Cancer Trials Group
NETWORK
University College, London
OTHER
Responsible Party
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Cheryl Pugh
Clinical Project Manager
Principal Investigators
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Christopher Parker, MD
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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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
Countries
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References
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Parker CC, Clarke NW, Catton C, Kynaston H, Cook A, Cross W, Davidson C, Goldstein C, Logue J, Maniatis C, Petersen PM, Neville P, Payne H, Persad R, Pugh C, Stirling A, Saad F, Parulekar WR, Parmar MKB, Sydes MR. RADICALS-HD: Reflections before the Results are Known. Clin Oncol (R Coll Radiol). 2022 Sep;34(9):593-597. doi: 10.1016/j.clon.2022.06.004. Epub 2022 Jul 6. No abstract available.
Parker CC, Clarke NW, Cook AD, Kynaston HG, Petersen PM, Catton C, Cross W, Logue J, Parulekar W, Payne H, Persad R, Pickering H, Saad F, Anderson J, Bahl A, Bottomley D, Brasso K, Chahal R, Cooke PW, Eddy B, Gibbs S, Goh C, Gujral S, Heath C, Henderson A, Jaganathan R, Jakobsen H, James ND, Kanaga Sundaram S, Lees K, Lester J, Lindberg H, Money-Kyrle J, Morris S, O'Sullivan J, Ostler P, Owen L, Patel P, Pope A, Popert R, Raman R, Roder MA, Sayers I, Simms M, Wilson J, Zarkar A, Parmar MKB, Sydes MR. Timing of radiotherapy after radical prostatectomy (RADICALS-RT): a randomised, controlled phase 3 trial. Lancet. 2020 Oct 31;396(10260):1413-1421. doi: 10.1016/S0140-6736(20)31553-1. Epub 2020 Sep 28.
Vale CL, Fisher D, Kneebone A, Parker C, Pearse M, Richaud P, Sargos P, Sydes MR, Brawley C, Brihoum M, Brown C, Chabaud S, Cook A, Forcat S, Fraser-Browne C, Latorzeff I, Parmar MKB, Tierney JF; ARTISTIC Meta-analysis Group. Adjuvant or early salvage radiotherapy for the treatment of localised and locally advanced prostate cancer: a prospectively planned systematic review and meta-analysis of aggregate data. Lancet. 2020 Oct 31;396(10260):1422-1431. doi: 10.1016/S0140-6736(20)31952-8. Epub 2020 Sep 28.
Parker CC, Clarke NW, Cook AD, Kynaston H, Catton CN, Cross WR, Petersen PM, Persad RA, Saad F, Bower LC, Logue J, Payne H, Forcat S, Goldstein C, Murphy C, Anderson J, Barkati M, Bottomley DM, Branagan J, Choudhury A, Chung PWM, Cogley L, Goh CL, Hoskin P, Khoo V, Malone SC, Masters L, Morris SL, Nabid A, Ong AD, Raman R, Tarver KL, Tree AC, Worlding J, Wylie JP, Zarkar AM, Parulekar WR, Parmar MKB, Sydes MR; RADICALS investigators. Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial. Lancet. 2024 Jun 1;403(10442):2405-2415. doi: 10.1016/S0140-6736(24)00548-8. Epub 2024 May 16.
Parker CC, Kynaston H, Cook AD, Clarke NW, Catton CN, Cross WR, Petersen PM, Persad RA, Pugh CA, Saad F, Logue J, Payne H, Bower LC, Brawley C, Rauchenberger M, Barkati M, Bottomley DM, Brasso K, Chung HT, Chung PWM, Conroy R, Falconer A, Ford V, Goh CL, Heath CM, James ND, Kim-Sing C, Kodavatiganti R, Malone SC, Morris SL, Nabid A, Ong AD, Raman R, Rodda S, Wells P, Worlding J, Parulekar WR, Parmar MKB, Sydes MR; RADICALS investigators. Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial. Lancet. 2024 Jun 1;403(10442):2416-2425. doi: 10.1016/S0140-6736(24)00549-X. Epub 2024 May 16.
Parker CC, Petersen PM, Cook AD, Clarke NW, Catton C, Cross WR, Kynaston H, Parulekar WR, Persad RA, Saad F, Bower L, Durkan GC, Logue J, Maniatis C, Noor D, Payne H, Anderson J, Bahl AK, Bashir F, Bottomley DM, Brasso K, Capaldi L, Chung C, Cooke PW, Donohue JF, Eddy B, Heath CM, Henderson A, Henry A, Jaganathan R, Jakobsen H, James ND, Joseph J, Lees K, Lester J, Lindberg H, Makar A, Morris SL, Oommen N, Ostler P, Owen L, Patel P, Pope A, Popert R, Raman R, Ramani V, Roder A, Sayers I, Simms M, Srinivasan V, Sundaram S, Tarver KL, Tran A, Wells P, Wilson J, Zarkar AM, Parmar MKB, Sydes MR; RADICALS investigators. Timing of radiotherapy (RT) after radical prostatectomy (RP): long-term outcomes in the RADICALS-RT trial (NCT00541047). Ann Oncol. 2024 Jul;35(7):656-666. doi: 10.1016/j.annonc.2024.03.010. Epub 2024 Apr 5.
Other Identifiers
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MRC-RADICALS-PR10
Identifier Type: OTHER
Identifier Source: secondary_id
ISRCTN40814031
Identifier Type: REGISTRY
Identifier Source: secondary_id
2006-000205-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NCT00541047
Identifier Type: OTHER
Identifier Source: secondary_id
00316/0223/001-0001
Identifier Type: OTHER
Identifier Source: secondary_id
PR13
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CDR0000571528
Identifier Type: -
Identifier Source: org_study_id
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