RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery
Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS)
7 other identifiers
interventional
4,236
2 countries
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2007
Longer than P75 for phase_3
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2007
CompletedFirst Posted
Study publicly available on registry
October 8, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2022
CompletedNovember 13, 2023
November 1, 2023
14.7 years
October 5, 2007
November 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Freedom from treatment failure
up 12 years
Clinical progression-free survival
up 12 years
Overall survival
up 12 years
Non-protocol hormone therapy
up 12 years
Treatment toxicity
up 12 years
- +2 more secondary outcomes
Study Arms (5)
RADICALS-RT: Early RT
EXPERIMENTALRADICALS-RT: Salvage RT
EXPERIMENTALRADICALS-HD: Radiotherapy Alone
EXPERIMENTALRADICALS-HD: Radiotherapy + 6 months
EXPERIMENTALRADICALS-HD: Radiotherapy + 24 months
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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:
- See Disease Characteristics
- Co-enrollment to other trials is permitted, providing this does not interfere with the outcome measures
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- Canadian Cancer Trials Groupcollaborator
Study Sites (58)
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
Ottawa Health Research Institute
Ottawa, Ontario, K1Y 4E9, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
William Harvey Hospital
Ashford, England, TN24 0LZ, United Kingdom
North Devon District Hospital
Barnstaple, England, EX31 4JB, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, RG24 9NA, United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2TH, United Kingdom
Royal Bournemouth Hospital
Bournemouth, England, BH7 7DW, United Kingdom
Bradford Royal Infirmary
Bradford, England, BD9 6RJ, United Kingdom
Southmead Hospital
Bristol, England, BS10 5NB, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED, United Kingdom
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, CT1 3NG, United Kingdom
Walsgrave Hospital
Coventry, England, CV2 2DX, United Kingdom
Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, England, CW1 4QJ, United Kingdom
Mayday University Hospital
Croydon, England, United Kingdom
Doncaster Royal Infirmary
Doncaster, England, DN2 5LT, United Kingdom
Dorset County Hospital
Dorchester, England, DT1 2JY, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX, United Kingdom
Princess Alexandra Hospital
Harlow, England, CM20 1QX, United Kingdom
Ipswich Hospital
Ipswich, England, IP4 5PD, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF, United Kingdom
Lincoln County Hospital
Lincoln, England, LN2 5QY, United Kingdom
Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, England, N18 1QX, United Kingdom
University College Hospital
London, England, NW1 2BU, United Kingdom
Guy's Hospital
London, England, SE1 9RT, United Kingdom
Royal Marsden - London
London, England, SW3 6JJ, United Kingdom
Maidstone Hospital
Maidstone, England, ME16 9QQ, United Kingdom
Clatterbridge Centre for Oncology
Manchester, England, CH63 4JY, United Kingdom
Christie Hospital
Manchester, England, M20 4BX, United Kingdom
James Cook University Hospital
Middlesbrough, England, TS4 3BW, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN, United Kingdom
Derriford Hospital
Plymouth, England, PL6 8DH, United Kingdom
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB, United Kingdom
Queen's Hospital
Romford, England, RM7 0AG, United Kingdom
Rotherham General Hospital
Rotherham, England, S60 2UD, United Kingdom
Hope Hospital
Salford, England, M6 8HD, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ, United Kingdom
Southampton General Hospital
Southampton, England, SO16 6YD, United Kingdom
Stepping Hill Hospital
Stockport, England, SK2 7JE, United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, England, ST4 7LN, United Kingdom
Royal Marsden - Surrey
Sutton, England, SM2 5PT, United Kingdom
Torbay Hospital
Torquay, England, TQ2 7AA, United Kingdom
Hillingdon Hospital
Uxbridge, England, UB8 3NN, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY, United Kingdom
Cancer Care Centre at York Hospital
York, England, Y031 8HE, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN, United Kingdom
Ayr Hospital
Ayr, Scotland, KA6 6DX, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN, United Kingdom
Pinderfields General Hospital
Wakefield, Scotland, WF1 4DG, United Kingdom
Glan Clwyd Hospital
Bodelwyddan, Wales, LL 18 5UJ, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL, United Kingdom
University Hospital of Wales
Cardiff, Wales, CF14 4XW, United Kingdom
Royal Gwent Hospital
Newport, Wales, NP9 2UB, United Kingdom
Related Publications (6)
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.
PMID: 35810050RESULTParker 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.
PMID: 33002429RESULTVale 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.
PMID: 33002431RESULTParker 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.
PMID: 38763154DERIVEDParker 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.
PMID: 38763153DERIVEDParker 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.
PMID: 38583574DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christopher Parker, MD
Royal Marsden NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Project Manager
Study Record Dates
First Submitted
October 5, 2007
First Posted
October 8, 2007
Study Start
November 1, 2007
Primary Completion
July 27, 2022
Study Completion
July 27, 2022
Last Updated
November 13, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share
Data can be shared on request via emailing mrcctu.radical@ucl.ac.uk