Radiotherapy for Prostate Cancer: is it ‘what you do’ or ‘the way that you do it’? A UK Perspective on Technique and Quality Assurance

Jones, Gareth Wyn; Donovan, Jenny; Neal, David E.; Hamdy, Freddie C.; Lane, J. Athene; Bonnington, Sue; Bradshaw, Lynne; Cooper, Debbie; Elliott, Emma; Herbert, Pippa; Holding, Peter; Howson, Joanne; Jones, Mandy; Lennon, T; Lyons, Norma; Moody, Hilary; Plumb, Claire; O'Sullivan, Tricia; Salter, Liz; Tidball, Sarah; Thompson, Pauline; Adam, Tonia; Askew, Sarah; Atkinson, Sharon; Baynes, Tim; Blaikie, Jan; Brain, Carole; Breen, Viv; Brunt, Sarah; Bryne, Sean; Bythem, Jo; Clarke, Jenny; Cloete, Jenny; Dark, Susan; Davis, Gill; Rue, Rachael De La; Denizot, Jane; Dewhurst, Elspeth; Dimes, Anna; Dixon, Nicola; Ebbs, Penny; Emmerson, Ingrid; Ferguson, Jill; Gadd, Ali; Geoghegan, Lisa; Grant, Alison D.; Grant, Collette; Gray, Catherine; Godfrey, Rosemary; Goodwin, Louise; Hall, Susie; Hart, Liz; Harvey, Andrew; Hoult, Chloe; Hawkins, Sarah; Holling, Sharon; Innes, A.J; Kilner, Sue; Marshall, Fiona; Mellen, Louise; Moore, Andrea; Napier, Sally; Needham, Julie; Pearse, Kevin; Pisa, Anna; Rees, Mark I.; Richards, Elliw; Robson, Lindsay; Roxburgh, Janet; Samuel, Nikki; Sharkey, Irene; Slater, Michael D.; Smith, Donna; Taggart, Pippa; Taylor, H.; Taylor, Vicky; Thomas, Ayesha; Tomkies, Briony; Trewick, Nicola; Ward, Claire; Walker, Christy; Williams, Ayesha; Woodhouse, Colin; Wyber, Elizabeth; Aning, Jonathan; Bollina, Prasad; Catto, James W.F.; Doble, Andrew; Doherty, Alan; Durkan, G.; Gillatt, David; Hughes, Owen; Kocklebergh, Roger; Kouparis, Anthony; Kynaston, Howard; Leung, Hing Y.; Mariappan, Param; McNeill, Alan; Páez, Edgar; Paul, Alan; Persad, Raj; Powell, P. H.; Prescott, Stephen M.; Rosario, Derek J.; Rowe, Edward; Schwaibold, Hartwig; Tulloch, David; Wallace, Mike; Bahl, Amit; Benson, Richard; Beresford, Mark; Ferguson, Catherine; Graham, John D.; Herbert, Chris; James, Nicholas D.; Law, Alastair; Loughrey, Carmel; Mason, Malcolm David; McClaren, Duncan; Patterson, Helen; Pedley, Ian; Robinson, Angus; Russell, Simon; Staffurth, John; Symonds, Paul; Thanvi, Narottam; Vasanthan, Subramaniam; Wilson, Paula; Appleby, Helen; Ash, Dominic; Aston, Dean; Bolton, Steven; Chalmers, Graham; Conway, J.; Early, Nick; Geater, Tony; Goddall, Lynda; Heymann, Claire; Hicks, Deborah; Jones, Liza; Lamb, Susan; Lambert, G.; Lawrence, Gill; Lewis, Geraint; Lilley, J.; MacLeod, Aileen; Massey, Pauline; McQueen, Alison; Moore, Rollo; Penketh, Lynda; Potterton, Janet; Roberts, Neil; Showler, Helen; Slade, Stephen; Steele, Alasdair; Swinscoe, James; Tiffany, Marie; Townley, John; Treeby, Jo; Wilkinson, Joyce; Williams, Lorraine; Wills, L.; Woodley, O.; Yarrow, Sue; Bhattarai, Selina; Deshmukh, Neeta; Dormer, John; Fernando, Malee; Goepel, J R; Griffiths, David; Grigor, Ken; Mayer, Nick; Oxley, Jon; Robinson, Mary C.; Varma, Murali; Warren, Anne Y.; Brindle, Lucy; Davis, Michael J.; Dedman, Dan; Down, Elizabeth; Khazragui, Hanan; Metcalfe, Chris; Noble, Sian; Peters, Tim; Taylor, Hilary; Turner, Emma L; Wade, Julia; Walsh, Eleanor; Baker, Susan; Bellis‐Sheldon, Elizabeth; Bougard, Chantal; Bowtell, Joanne; Brewer, Catherine; Burton, C.R.; Charlton, J. E.; Christoforou, Nicholas; Clark, Rebecca; Coull, Susan; Croker, Christine; Currer, Rosemary; Daisey, Claire; Delaney, Gill; Donohue, Rose; Drew, Jane; Farmer, Rebecca L.; Fry, Susan; Haddow, Jean; Hale, Alex; Halpin, Susan; Harris, Belle; Hattrick, Barbara; Holmes, Sharon; Hunt, H. Allan; Jackson, Vicky; Johnson, Donna; Butt, Mandy Le; Leworthy, Jo; Liddiatt, Tanya; Martín, A.; Mauree, Jainee; Moore, Susan M.; Moulam, Gill; Mutch, Jackie; Parker, Kathleen; Pawsey, Christopher; Purdie, Michelle; Robson, Teresa; Smith, Lynne; Stenton, Carole; Steuart‐Feilding, Tom; Sully, Chris; Sutton, Caroline; Torrington, Carol; Wilkins, Zoe; Williams, S. Lloyd; Wilson, Andrea; Grant, Adrian; Roberts, Ian; Ashby, Deborah; Cowan, Richard A; Fayers, Peter; Mellon, Killian; N’Dow, James; O’Brien, Tim; Sokhal, Michael; Baum, Michael; Adolfson, Jan; Albertsen, Peter C.; Dearnaley, David P.; Schroeder, Fritz H.; Roberts, Tracy E; Zietman, Anthony

doi:10.1016/j.clon.2016.05.011

Cited by 7 publications

(8 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The protocol for quality assurance followed the RT01 trial procedures. [7][8][9] The trial oncologist held a review appointment with participants if PSA levels rose by at least 2.0 ng per milliliter above the nadir or if concerns were raised about progression. Management options included continued monitoring, additional testing, salvage therapy, or palliative treatments.…”

Section: Treatment Procedures and Clinical Managementmentioning

confidence: 99%

10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer

Hamdy

Donovan

Lane³

et al. 2016

N Engl J Med

Self Cite

2,196

1,725

View full text Add to dashboard Cite

General rightsThis document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/pure/about/ebr-terms T h e ne w e ngl a nd jou r na l o f m e dicine n engl j med nejm.org This article was published on September 14, 2016, at NEJM.org. DOI: 10.1056/NEJMoa1606220Copyright © 2016 Massachusetts Medical Society. BACKGROUNDThe comparative effectiveness of treatments for prostate cancer that is detected by prostate-specific antigen (PSA) testing remains uncertain. METHODSWe compared active monitoring, radical prostatectomy, and external-beam radiotherapy for the treatment of clinically localized prostate cancer. Between 1999 and 2009, a total of 82,429 men 50 to 69 years of age received a PSA test; 2664 received a diagnosis of localized prostate cancer, and 1643 agreed to undergo randomization to active monitoring (545 men), surgery (553), or radiotherapy (545). The primary outcome was prostate-cancer mortality at a median of 10 years of follow-up. Secondary outcomes included the rates of disease progression, metastases, and all-cause deaths. RESULTSThere were 17 prostate-cancer-specific deaths overall: 8 in the active-monitoring group (1.5 deaths per 1000 person-years; 95% confidence interval [CI], 0.7 to 3.0), 5 in the surgery group (0.9 per 1000 person-years; 95% CI, 0.4 to 2.2), and 4 in the radiotherapy group (0.7 per 1000 person-years; 95% CI, 0.3 to 2.0); the difference among the groups was not significant (P = 0.48 for the overall comparison). In addition, no significant difference was seen among the groups in the number of deaths from any cause (169 deaths overall; P = 0.87 for the comparison among the three groups). Metastases developed in more men in the active-monitoring group (33 men; 6.3 events per 1000 person-years; 95% CI, 4.5 to 8.8) than in the surgery group (13 men; 2.4 per 1000 person-years; 95% CI, 1.4 to 4.2) or the radiotherapy group (16 men; 3.0 per 1000 person-years; 95% CI, 1.9 to 4.9) (P = 0.004 for the overall comparison). Higher rates of disease progression were seen in the activemonitoring group (112 men; 22.9 events per 1000 person-years; 95% CI, 19.0 to 27.5) than in the surgery group (46 men; 8.9 events per 1000 person-years; 95% CI, 6.7 to 11.9) or the radiotherapy group (46 men; 9.0 events per 1000 person-years; 95% CI, 6.7 to 12.0) (P<0.001 for the overall comparison). CONCLUSIONSAt a median of 10 years, prostate-cancer-specific mortality was low irrespective of the treatment assigned, with no significant difference among treatments. Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring.

show abstract

Section: Treatment Procedures and Clinical Managementmentioning

confidence: 99%

10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer

Hamdy

Donovan

Lane³

et al. 2016

N Engl J Med

Self Cite

2,196

1,725

View full text Add to dashboard Cite

show abstract

“…Quality assurance followed the RT01 trial procedures. [129][130][131] There has been an increasingly sophisticated quality assurance programme in prostate radiotherapy trials over the last 15 years, reflecting dose escalation and treatment complexity. In ProtecT, machine dosimetry results were comparable between trial centres and with the UK RT01 trial.…”

Section: Quality Assurancementioning

confidence: 99%

“…In ProtecT, machine dosimetry results were comparable between trial centres and with the UK RT01 trial. [129][130][131] The outlining review showed that most deviations were clinically acceptable, although three (1.4%) may have been of clinical significance and were related to outlining of the prostate. Seminal vesicle outlining varied, possibly due to several prostate trials running concurrently with different protocols.…”

Section: Quality Assurancementioning

confidence: 99%

Active monitoring, radical prostatectomy and radical radiotherapy in PSA-detected clinically localised prostate cancer: the ProtecT three-arm RCT

Hamdy

Donovan

Lane

et al. 2020

Health Technol Assess

Self Cite

View full text Add to dashboard Cite

Background Prostate cancer is the most common cancer among men in the UK. Prostate-specific antigen testing followed by biopsy leads to overdetection, overtreatment as well as undertreatment of the disease. Evidence of treatment effectiveness has lacked because of the paucity of randomised controlled trials comparing conventional treatments. Objectives To evaluate the effectiveness of conventional treatments for localised prostate cancer (active monitoring, radical prostatectomy and radical radiotherapy) in men aged 50–69 years. Design A prospective, multicentre prostate-specific antigen testing programme followed by a randomised trial of treatment, with a comprehensive cohort follow-up. Setting Prostate-specific antigen testing in primary care and treatment in nine urology departments in the UK. Participants Between 2001 and 2009, 228,966 men aged 50–69 years received an invitation to attend an appointment for information about the Prostate testing for cancer and Treatment (ProtecT) study and a prostate-specific antigen test; 82,429 men were tested, 2664 were diagnosed with localised prostate cancer, 1643 agreed to randomisation to active monitoring (n = 545), radical prostatectomy (n = 553) or radical radiotherapy (n = 545) and 997 chose a treatment. Interventions The interventions were active monitoring, radical prostatectomy and radical radiotherapy. Trial primary outcome measure Definite or probable disease-specific mortality at the 10-year median follow-up in randomised participants. Secondary outcome measures Overall mortality, metastases, disease progression, treatment complications, resource utilisation and patient-reported outcomes. Results There were no statistically significant differences between the groups for 17 prostate cancer-specific (p = 0.48) and 169 all-cause (p = 0.87) deaths. Eight men died of prostate cancer in the active monitoring group (1.5 per 1000 person-years, 95% confidence interval 0.7 to 3.0); five died of prostate cancer in the radical prostatectomy group (0.9 per 1000 person-years, 95% confidence interval 0.4 to 2.2 per 1000 person years) and four died of prostate cancer in the radical radiotherapy group (0.7 per 1000 person-years, 95% confidence interval 0.3 to 2.0 per 1000 person years). More men developed metastases in the active monitoring group than in the radical prostatectomy and radical radiotherapy groups: active monitoring, n = 33 (6.3 per 1000 person-years, 95% confidence interval 4.5 to 8.8); radical prostatectomy, n = 13 (2.4 per 1000 person-years, 95% confidence interval 1.4 to 4.2 per 1000 person years); and radical radiotherapy, n = 16 (3.0 per 1000 person-years, 95% confidence interval 1.9 to 4.9 per 1000 person-years; p = 0.004). There were higher rates of disease progression in the active monitoring group than in the radical prostatectomy and radical radiotherapy groups: active monitoring (n = 112; 22.9 per 1000 person-years, 95% confidence interval 19.0 to 27.5 per 1000 person years); radical prostatectomy (n = 46; 8.9 per 1000 person-years, 95% confidence interval 6.7 to 11.9 per 1000 person-years); and radical radiotherapy (n = 46; 9.0 per 1000 person-years, 95% confidence interval 6.7 to 12.0 per 1000 person years; p < 0.001). Radical prostatectomy had the greatest impact on sexual function/urinary continence and remained worse than radical radiotherapy and active monitoring. Radical radiotherapy’s impact on sexual function was greatest at 6 months, but recovered somewhat in the majority of participants. Sexual and urinary function gradually declined in the active monitoring group. Bowel function was worse with radical radiotherapy at 6 months, but it recovered with the exception of bloody stools. Urinary voiding and nocturia worsened in the radical radiotherapy group at 6 months but recovered. Condition-specific quality-of-life effects mirrored functional changes. No differences in anxiety/depression or generic or cancer-related quality of life were found. At the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year, the probabilities that each arm was the most cost-effective option were 58% (radical radiotherapy), 32% (active monitoring) and 10% (radical prostatectomy). Limitations A single prostate-specific antigen test and transrectal ultrasound biopsies were used. There were very few non-white men in the trial. The majority of men had low- and intermediate-risk disease. Longer follow-up is needed. Conclusions At a median follow-up point of 10 years, prostate cancer-specific mortality was low, irrespective of the assigned treatment. Radical prostatectomy and radical radiotherapy reduced disease progression and metastases, but with side effects. Further work is needed to follow up participants at a median of 15 years. Trial registration Current Controlled Trials ISRCTN20141297. Funding This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 37. See the National Institute for Health Research Journals Library website for further project information.

show abstract

“…Главная цель лучевой терапии (ЛТ) -уничтожение опухолевых клеток при усло-вии максимального щажения окружающих нормальных органов и тканей [1][2][3][4]. Однако, несмотря на все современные достижения и техническое обеспечение в области ЛТ, в реальных условиях невозможно подвести к новообразованию необходимую суммар-ную дозу и полностью избежать при этом облучения здоровых тканей, особенно при глубоко расположенных опухолях [3][4][5].…”

Section: Analysis Of the Frequency Of Radiation Therapy Complicationsunclassified

“…Однако, несмотря на все современные достижения и техническое обеспечение в области ЛТ, в реальных условиях невозможно подвести к новообразованию необходимую суммар-ную дозу и полностью избежать при этом облучения здоровых тканей, особенно при глубоко расположенных опухолях [3][4][5]. В результате облучения нормальных тканей и органов возникают лучевые реакции и осложнения различной степени тяжести, которые существенным образом ухудшают качество жизни пациентов [6][7][8][9][10].…”

Section: Analysis Of the Frequency Of Radiation Therapy Complicationsunclassified

Analysis of the frequency of radiation therapy complications in patients with prostate cancer

Isaev¹,

Гусейн²,

Гулиев³

et al. 2017

Kazan Med J

View full text Add to dashboard Cite

Aim. Study of the frequency of radiation therapy complications in patients with prostate cancer. Methods. The study included 142 patients who underwent radiation therapy combined with hormonal therapy in 2001-2015. Average age of patients was 68 years. All of them received 3D-conformal radiotherapy by linear accelerators with 6 to 15 MV photon beams. Single boost dose was 2 Gy, total boost dose was 75 Gy. We studied frequency and severity of acute hematological toxicity and early and late gastroenterological and urological complications of the treatment. Treatment-related toxicity was assessed by RTOG/ EORTC and CTCAE v. 4.0 scales. Results. Early radiation-induced proctitis of I, II and III degree were registered in 95 (66.9%), 32 (22.5%) and 8 (5.6%) patients, respectively. Acute cystitis of I, II and III degree were noted in 22 (15.5%), 87 (61.3%) and 16 (11.3%) patients, respectively. Signs of late radiation-induced proctitis of I degree was diagnosed in 21 (14.8%) cases. Late radiation-induced cystitis of I degree was diagnoswed in 37 (26.1%) patients. No late complications of higher severity occurred. Conclusion. The results of the conducted study showed that use of high-tech precision external-beam radiotherapy techniques in the treatment of prostate cancer along with high efficacy allows to reduce the number of early and late complications.

show abstract

Radiotherapy for Prostate Cancer: is it ‘what you do’ or ‘the way that you do it’? A UK Perspective on Technique and Quality Assurance

Cited by 7 publications

References 35 publications

10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer

10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer

Active monitoring, radical prostatectomy and radical radiotherapy in PSA-detected clinically localised prostate cancer: the ProtecT three-arm RCT

Analysis of the frequency of radiation therapy complications in patients with prostate cancer

Contact Info

Product

Resources

About