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Open Access 01-12-2011 | Study protocol

Single blind randomized Phase III trial to investigate the benefit of a focal lesion ablative microboost in prostate cancer (FLAME-trial): study protocol for a randomized controlled trial

Authors: Irene M Lips, Uulke A van der Heide, Karin Haustermans, Emile NJT van Lin, Floris Pos, Stefan PG Franken, Alexis NTJ Kotte, Carla H van Gils, Marco van Vulpen

Published in: Trials | Issue 1/2011

Abstract

Background

The treatment results of external beam radiotherapy for intermediate and high risk prostate cancer patients are insufficient with five-year biochemical relapse rates of approximately 35%. Several randomized trials have shown that dose escalation to the entire prostate improves biochemical disease free survival. However, further dose escalation to the whole gland is limited due to an unacceptable high risk of acute and late toxicity. Moreover, local recurrences often originate at the location of the macroscopic tumor, so boosting the radiation dose at the macroscopic tumor within the prostate might increase local control. A reduction of distant metastases and improved survival can be expected by reducing local failure. The aim of this study is to investigate the benefit of an ablative microboost to the macroscopic tumor within the prostate in patients treated with external beam radiotherapy for prostate cancer.

Methods/Design

The FLAME-trial (F ocal L esion A blative M icroboost in prostatE cancer) is a single blind randomized controlled phase III trial. We aim to include 566 patients (283 per treatment arm) with intermediate or high risk adenocarcinoma of the prostate who are scheduled for external beam radiotherapy using fiducial markers for position verification. With this number of patients, the expected increase in five-year freedom from biochemical failure rate of 10% can be detected with a power of 80%. Patients allocated to the standard arm receive a dose of 77 Gy in 35 fractions to the entire prostate and patients in the experimental arm receive 77 Gy to the entire prostate and an additional integrated microboost to the macroscopic tumor of 95 Gy in 35 fractions. The secondary outcome measures include treatment-related toxicity, quality of life and disease-specific survival. Furthermore, by localizing the recurrent tumors within the prostate during follow-up and correlating this with the delivered dose, we can obtain accurate dose-effect information for both the macroscopic tumor and subclinical disease in prostate cancer. The rationale, study design and the first 50 patients included are described.

Trial registration

This study is registered at ClinicalTrials.gov: NCT01168479

Available only for authorised users

Lu-Yao GL, Yao SL: Population-based study of long-term survival in patients with clinically localised prostate cancer. Lancet. 1997, 349 (9056): 906-910.CrossRefPubMed

Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I: Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002, 53 (5): 1097-1105.CrossRefPubMed

Widmark A, Klepp O, Solberg A, Damber JE, Angelsen A, Fransson P, Lund JA, Tasdemir I, Hoyer M, Wiklund F, Fossa SD, Scandinavian Prostate Cancer Group Study 7, Swedish Association for Urological Oncology 3: Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial. Lancet. 2009, 373 (9660): 301-308.CrossRefPubMed

Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV: Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006, 24 (13): 1990-1996.CrossRefPubMed

Zietman AL, DeSilvio ML, Slater JD, Rossi CJ, Miller DW, Adams JA, Shipley WU: Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005, 294 (10): 1233-1239.CrossRefPubMed

Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK, RT01 collaborators: Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007, 8 (6): 475-487.CrossRefPubMed

Zelefsky MJ, Fuks Z, Hunt M, Yamada Y, Marion C, Ling CC, Amols H, Venkatraman ES, Leibel SA: High-dose intensity modulated radiation therapy for prostate cancer: early toxicity and biochemical outcome in 772 patients. Int J Radiat Oncol Biol Phys. 2002, 53 (5): 1111-1116.CrossRefPubMed

Nahum AE, Movsas B, Horwitz EM, Stobbe CC, Chapman JD: Incorporating clinical measurements of hypoxia into tumor local control modeling of prostate cancer: implications for the alpha/beta ratio. Int J Radiat Oncol Biol Phys. 2003, 57 (2): 391-401.CrossRefPubMed

Pucar D, Hricak H, Shukla-Dave A, Kuroiwa K, Drobnjak M, Eastham J, Scardino PT, Zelefsky MJ: Clinically significant prostate cancer local recurrence after radiation therapy occurs at the site of primary tumor: magnetic resonance imaging and step-section pathology evidence. Int J Radiat Oncol Biol Phys. 2007, 69 (1): 62-69.CrossRefPubMed

10.

Cellini N, Morganti AG, Mattiucci GC, Valentini V, Leone M, Luzi S, Manfredi R, Dinapoli N, Digesu' C, Smaniotto D: Analysis of intraprostatic failures in patients treated with hormonal therapy and radiotherapy: implications for conformal therapy planning. Int J Radiat Oncol Biol Phys. 2002, 53 (3): 595-599.CrossRefPubMed

11.

Coen JJ, Zietman AL, Thakral H, Shipley WU: Radical radiation for localized prostate cancer: local persistence of disease results in a late wave of metastases. J Clin Oncol. 2002, 20 (15): 3199-3205.CrossRefPubMed

12.

Kupelian PA, Ciezki J, Reddy CA, Klein EA, Mahadevan A: Effect of increasing radiation doses on local and distant failures in patients with localized prostate cancer. Int J Radiat Oncol Biol Phys. 2008, 71 (1): 16-22.CrossRefPubMed

13.

Jacob R, Hanlon AL, Horwitz EM, Movsas B, Uzzo RG, Pollack A: The relationship of increasing radiotherapy dose to reduced distant metastases and mortality in men with prostate cancer. Cancer. 2004, 100 (3): 538-543.CrossRefPubMed

14.

Lips IM, van der Heide UA, Kotte AN, van Vulpen M, Bel A: Effect of translational and rotational errors on complex dose distributions with off-line and on-line position verification. Int J Radiat Oncol Biol Phys. 2009, 74 (5): 1600-1608.CrossRefPubMed

15.

van Lin EN, Futterer JJ, Heijmink SW, van der Vight LP, Hoffmann AL, van Kollenburg P, Huisman HJ, Scheenen TW, Witjes JA, Leer JW, Barentsz JO, Visser AG: IMRT boost dose planning on dominant intraprostatic lesions: gold marker-based three-dimensional fusion of CT with dynamic contrast-enhanced and 1H-spectroscopic MRI. Int J Radiat Oncol Biol Phys. 2006, 65 (1): 291-303.CrossRefPubMed

16.

Miralbell R, Molla M, Rouzaud M, Hidalgo A, Toscas JI, Lozano J, Sanz S, Ares C, Jorcano S, Linero D, Escude L: Hypofractionated boost to the dominant tumor region with intensity modulated stereotactic radiotherapy for prostate cancer: a sequential dose escalation pilot study. Int J Radiat Oncol Biol Phys. 2010, 78 (1): 50-57.CrossRefPubMed

17.

Gaudet M, Vigneault E, Aubin S, Varfalvy N, Harel F, Beaulieu L, Martin AG: Dose escalation to the dominant intraprostatic lesion defined by sextant biopsy in a permanent prostate I-125 implant: a prospective comparative toxicity analysis. Int J Radiat Oncol Biol Phys. 2010, 77 (1): 153-159.CrossRefPubMed

18.

Fonteyne V, Villeirs G, Speleers B, De Neve W, De Wagter C, Lumen N, De Meerleer G: Intensity-modulated radiotherapy as primary therapy for prostate cancer: report on acute toxicity after dose escalation with simultaneous integrated boost to intraprostatic lesion. Int J Radiat Oncol Biol Phys. 2008, 72 (3): 799-807.CrossRefPubMed

19.

De Meerleer G, Villeirs G, Bral S, Paelinck L, De Gersem W, Dekuyper P, De Neve W: The magnetic resonance detected intraprostatic lesion in prostate cancer: planning and delivery of intensity-modulated radiotherapy. Radiother Oncol. 2005, 75 (3): 325-333.CrossRefPubMed

20.

Singh AK, Guion P, Sears-Crouse N, Ullman K, Smith S, Albert PS, Fichtinger G, Choyke PL, Xu S, Kruecker J, Wood BJ, Krieger A, Ning H: Simultaneous integrated boost of biopsy proven, MRI defined dominant intra-prostatic lesions to 95 Gray with IMRT: early results of a phase I NCI study. Radiat Oncol. 2007, 2: 36-CrossRefPubMedPubMedCentral

21.

Ash D, Flynn A, Battermann J, de Reijke T, Lavagnini P, Blank L, ESTRA/EAU Urological Brachytherapy Group, EORTC Radiotherapy Group: ESTRO/EAU/EORTC recommendations on permanent seed implantation for localized prostate cancer. Radiother Oncol. 2000, 57 (3): 315-321.CrossRefPubMed

22.

Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP: Toxicity and response criteria of the eastern cooperative oncology group. Am J Clin Oncol. 1982, 5 (6): 649-655.CrossRefPubMed

23.

Peeters ST, Heemsbergen WD, van Putten WL, Slot A, Tabak H, Mens JW, Lebesque JV, Koper PC: Acute and late complications after radiotherapy for prostate cancer: results of a multicenter randomized trial comparing 68 Gy to 78 Gy. Int J Radiat Oncol Biol Phys. 2005, 61 (4): 1019-1034.CrossRefPubMed

24.

Sandhu AS, Zelefsky MJ, Lee HJ, Lombardi D, Fuks Z, Leibel SA: Long-term urinary toxicity after 3-dimensional conformal radiotherapy for prostate cancer in patients with prior history of transurethral resection. Int J Radiat Oncol Biol Phys. 2000, 48 (3): 643-647.CrossRefPubMed

25.

Schultheiss TE, Lee WR, Hunt MA, Hanlon AL, Peter RS, Hanks GE: Late GI and GU complications in the treatment of prostate cancer. Int J Radiat Oncol Biol Phys. 1997, 37 (1): 3-11.CrossRefPubMed

26.

van der Wielen GJ, van Putten WL, Incrocci L: Sexual function after three-dimensional conformal radiotherapy for prostate cancer: results from a dose-escalation trial. Int J Radiat Oncol Biol Phys. 2007, 68 (2): 479-484.CrossRefPubMed

27.

Zelefsky MJ, Cowen D, Fuks Z, Shike M, Burman C, Jackson A, Venkatramen ES, Leibel SA: Long term tolerance of high dose three-dimensional conformal radiotherapy in patients with localized prostate carcinoma. Cancer. 1999, 85 (11): 2460-2468.CrossRefPubMed

28.

Turner SL, Adams K, Bull CA, Berry MP: Sexual dysfunction after radical radiation therapy for prostate cancer: a prospective evaluation. Urology. 1999, 54 (1): 124-129.CrossRefPubMed

29.

Christie D, Denham J, Steigler A, Lamb D, Turner S, Mameghan H, Joseph D, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Spry NA, Tai KH, Wynne C, Duchesne G, Kovacev O, Francis L, Kramar A, D'Este C, Bill D: Delayed rectal and urinary symptomatology in patients treated for prostate cancer by radiotherapy with or without short term neo-adjuvant androgen deprivation. Radiother Oncol. 2005, 77 (2): 117-125.CrossRefPubMed

30.

Vavassori V, Fiorino C, Rancati T, Magli A, Fellin G, Baccolini M, Bianchi C, Cagna E, Mauro FA, Monti AF, Munoz F, Stasi M, Franzone P, Valdagni R: Predictors for rectal and intestinal acute toxicities during prostate cancer high-dose 3D-CRT: results of a prospective multicenter study. Int J Radiat Oncol Biol Phys. 2007, 67 (5): 1401-1410.CrossRefPubMed

31.

Moman MR, van der Heide UA, Kotte AN, van Moorselaar RJ, Bol GH, Franken SP, van Vulpen M: Long-term experience with transrectal and transperineal implantations of fiducial gold markers in the prostate for position verification in external beam radiotherapy; feasibility, toxicity and quality of life. Radiother Oncol. 2010, 96 (1): 38-42.CrossRefPubMed

32.

van der Heide UA, Kotte AN, Dehnad H, Hofman P, Lagenijk JJ, van Vulpen M: Analysis of fiducial marker-based position verification in the external beam radiotherapy of patients with prostate cancer. Radiother Oncol. 2007, 82 (1): 38-45.CrossRefPubMed

33.

Nederveen AJ, van der Heide UA, Hofman P, Welleweerd H, Lagendijk JJ: Partial boosting of prostate tumours. Radiother Oncol. 2001, 61 (2): 117-126.CrossRefPubMed

34.

Lips IM, Dehnad H, van Gils CH, Boeken Kruger AE, van der Heide UA, van Vulpen M: High-dose intensity-modulated radiotherapy for prostate cancer using daily fiducial marker-based position verification: acute and late toxicity in 331 patients. Radiat Oncol. 2008, 3: 15-CrossRefPubMedPubMedCentral

35.

Rasch C, Barillot I, Remeijer P, Touw A, van Herk M, Lebesque JV: Definition of the prostate in CT and MRI: a multi-observer study. Int J Radiat Oncol Biol Phys. 1999, 43 (1): 57-66.CrossRefPubMed

36.

Usmani N, Sloboda R, Kamal W, Ghosh S, Pervez N, Pedersen J, Yee D, Danielson B, Murtha A, Amanie J, Monajemi T: Can Images Obtained with High Field Strength Magnetic Resonance Imaging Reduce Contouring Variability of the Prostate?. Int J Radiat Oncol Biol Phys. 2010, 80 (3): 728-734.CrossRefPubMed

37.

Groenendaal G, van den Berg CA, Korporaal JG, Philippens ME, Luijten PR, van Vulpen M, van der Heide UA: Simultaneous MRI diffusion and perfusion imaging for tumor delineation in prostate cancer patients. Radiother Oncol. 2010, 95 (2): 185-190.CrossRefPubMed

38.

van der Heide UA, Korporaal JG, Groenendaal G, Franken SP, van Vulpen M: Functional MRI for tumor delineation in prostate radiation therapy. Imaging Med. 2011, 3 (2): 219-231.CrossRef

39.

Padhani AR: Dynamic contrast-enhanced MRI in clinical oncology: current status and future directions. J Magn Reson Imaging. 2002, 16 (4): 407-422.CrossRefPubMed

40.

Hosseinzadeh K, Schwarz SD: Endorectal diffusion-weighted imaging in prostate cancer to differentiate malignant and benign peripheral zone tissue. J Magn Reson Imaging. 2004, 20 (4): 654-661.CrossRefPubMed

41.

Scheidler J, Hricak H, Vigneron DB, Yu KK, Sokolov DL, Huang LR, Zaloudek CJ, Nelson SJ, Carroll PR, Kurhanewicz J: Prostate cancer: localization with three-dimensional proton MR spectroscopic imaging--clinicopathologic study. Radiology. 1999, 213 (2): 473-480.CrossRefPubMed

42.

Roach M, Hanks G, Thames H, Schellhammer P, Shipley WU, Sokol GH, Sandler H: Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys. 2006, 65 (4): 965-974.CrossRefPubMed

43.

Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, Langer C, Murphy B, Cumberlin R, Coleman CN, Rubin P: CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003, 13 (3): 176-181.CrossRefPubMed

44.

Hornbrook MC, Goodman MJ: Assessing relative health plan risk with the RAND-36 health survey. Inquiry. 1995, 32 (1): 56-74.PubMed

45.

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC: The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993, 85 (5): 365-376.CrossRefPubMed

46.

Borghede G, Sullivan M: Measurement of quality of life in localized prostatic cancer patients treated with radiotherapy. Development of a prostate cancer-specific module supplementing the EORTC QLQ-C30. Qual Life Res. 1996, 5 (2): 212-222.CrossRefPubMed

47.

Litwin MS, Fitzpatrick JM, Fossa SD, Newling DW: Defining an international research agenda for quality of life in men with prostate cancer. Prostate. 1999, 41 (1): 58-67.CrossRefPubMed

48.

Nout RA, van de Poll-Franse LV, Lybeert ML, Warlam-Rodenhuis CC, Jobsen JJ, Mens JW, Lutgens LC, Pras B, van Putten WL, Creutzberg CL: Long-term outcome and quality of life of patients with endometrial carcinoma treated with or without pelvic radiotherapy in the post operative radiation therapy in endometrial carcinoma 1 (PORTEC-1) trial. J Clin Oncol. 2011, 29 (13): 1692-1700.CrossRefPubMed

49.

Kornblith AB, Lan L, Archer L, Partridge A, Kimmick G, Hudis C, Winer E, Casey R, Bennett S, Cohen HJ, Muss HB: Quality of life of older patients with early-stage breast cancer receiving adjuvant chemotherapy: A companion study to cancer and leukemia group B 49907. J Clin Oncol. 2011, 29 (8): 1022-1028.CrossRefPubMedPubMedCentral

50.

Inoue S, Shiina H, Hiraoka T, Wake K, Sumura M, Honda S, Urakami S, Igawa M, Usui T: Five-year longitudinal effect of radical perineal prostatectomy on health-related quality of life in japanese men, using general and disease-specific measures. BJU Int. 2009, 104 (8): 1077-1084.CrossRefPubMed

51.

52.

Vickers AJ, Altman DG: Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001, 323 (7321): 1123-1124.CrossRefPubMedPubMedCentral

53.

Osoba D, Bezjak A, Brundage M, Zee B, Tu D, Pater J, Quality of Life Committee of the NCIC CTG: Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of The National Cancer Institute of Canada Clinical Trials Group. Eur J Cancer. 2005, 41 (2): 280-287.CrossRefPubMed

54.

Movsas B, Moughan J, Sarna L, Langer C, Werner-Wasik M, Nicolaou N, Komaki R, Machtay M, Wasserman T, Bruner DW: Quality of life supersedes the classic prognosticators for long-term survival in locally advanced non-small-cell lung cancer: an analysis of RTOG 9801. J Clin Oncol. 2009, 27 (34): 5816-5822.CrossRefPubMedPubMedCentral

55.

Mutanga TF, de Boer HC, van der Wielen GJ, Hoogeman MS, Incrocci L, Heijmen BJ: Margin Evaluation in the Presence of Deformation, Rotation, and Translation in Prostate and Entire Seminal Vesicle Irradiation with Daily Marker-Based Setup Corrections. Int J Radiat Oncol Biol Phys.

56.

Meijer GJ, de Klerk J, Bzdusek K, van den Berg HA, Janssen R, Kaus MR, Rodrigus P, van der Toorn PP: What CTV-to-PTV margins should be applied for prostate irradiation? Four-dimensional quantitative assessment using model-based deformable image registration techniques. Int J Radiat Oncol Biol Phys. 2008, 72 (5): 1416-1425.CrossRefPubMed

57.

Rijkhorst EJ, Lakeman A, Nijkamp J, de Bois J, van Herk M, Lebesque JV, Sonke JJ: Strategies for online organ motion correction for intensity-modulated radiotherapy of prostate cancer: prostate, rectum, and bladder dose effects. Int J Radiat Oncol Biol Phys. 2009, 75 (4): 1254-1260.CrossRefPubMed

58.

Kotte AN, Hofman P, Lagendijk JJ, van Vulpen M, van der Heide UA: Intrafraction motion of the prostate during external-beam radiation therapy: analysis of 427 patients with implanted fiducial markers. Int J Radiat Oncol Biol Phys. 2007, 69 (2): 419-425.CrossRefPubMed

59.

Pinkawa M, Asadpour B, Gagel B, Piroth MD, Holy R, Eble MJ: Prostate position variability and dose-volume histograms in radiotherapy for prostate cancer with full and empty bladder. Int J Radiat Oncol Biol Phys. 2006, 64 (3): 856-861.CrossRefPubMed

60.

Lips IM, Kotte AN, van Gils CH, van Leerdam ME, van der Heide UA, van Vulpen M: Influence of Antiflatulent Dietary Advice on Intrafraction Motion for Prostate Cancer Radiotherapy. Int J Radiat Oncol Biol Phys.

61.

Tofts PS, Brix G, Buckley DL, Evelhoch JL, Henderson E, Knopp MV, Larsson HB, Lee TY, Mayr NA, Parker GJ, Port RE, Taylor J, Weisskoff RM: Estimating kinetic parameters from dynamic contrast-enhanced T(1)-weighted MRI of a diffusable tracer: standardized quantities and symbols. J Magn Reson Imaging. 1999, 10 (3): 223-232.CrossRefPubMed

62.

Chao KK, Goldstein NS, Yan D, Vargas CE, Ghilezan MI, Korman HJ, Kernen KM, Hollander JB, Gonzalez JA, Martinez AA, Vicini FA, Kestin LL: Clinicopathologic analysis of extracapsular extension in prostate cancer: should the clinical target volume be expanded posterolaterally to account for microscopic extension?. Int J Radiat Oncol Biol Phys. 2006, 65 (4): 999-1007.CrossRefPubMed

63.

Lips I, Dehnad H, Kruger AB, van Moorselaar J, van der Heide U, Battermann J, van Vulpen M: Health-related quality of life in patients with locally advanced prostate cancer after 76 Gy intensity-modulated radiotherapy vs. 70 Gy conformal radiotherapy in a prospective and longitudinal study. Int J Radiat Oncol Biol Phys. 2007, 69 (3): 656-661.CrossRefPubMed

64.

Lips IM, van Gils CH, van der Heide UA, Kruger AE, van Vulpen M: Health-related quality of life 3 years after high-dose intensity-modulated radiotherapy with gold fiducial marker-based position verification. BJU Int. 2009, 103 (6): 762-767.CrossRefPubMed

65.

Marchand V, Bourdin S, Charbonnel C, Rio E, Munos C, Campion L, Bonnaud-Antignac A, Lisbona A, Mahe MA, Supiot S: No impairment of quality of life 18 months after high-dose intensity-modulated radiotherapy for localized prostate cancer: a prospective study. Int J Radiat Oncol Biol Phys. 2010, 77 (4): 1053-1059.CrossRefPubMed

66.

Zelefsky MJ, Chan H, Hunt M, Yamada Y, Shippy AM, Amols H: Long-term outcome of high dose intensity modulated radiation therapy for patients with clinically localized prostate cancer. J Urol. 2006, 176 (4 Pt 1): 1415-1419.CrossRefPubMed

67.

Pickett B, Vigneault E, Kurhanewicz J, Verhey L, Roach M: Static field intensity modulation to treat a dominant intra-prostatic lesion to 90 Gy compared to seven field 3-dimensional radiotherapy. Int J Radiat Oncol Biol Phys. 1999, 44 (4): 921-929.CrossRefPubMed

68.

Xia P, Pickett B, Vigneault E, Verhey LJ, Roach M: Forward or inversely planned segmental multileaf collimator IMRT and sequential tomotherapy to treat multiple dominant intraprostatic lesions of prostate cancer to 90 Gy. Int J Radiat Oncol Biol Phys. 2001, 51 (1): 244-254.CrossRefPubMed

69.

Langer DL, van der Kwast TH, Evans AJ, Trachtenberg J, Wilson BC, Haider MA: Prostate cancer detection with multi-parametric MRI: logistic regression analysis of quantitative T2, diffusion-weighted imaging, and dynamic contrast-enhanced MRI. J Magn Reson Imaging. 2009, 30 (2): 327-334.CrossRefPubMed

70.

van Vulpen M, van den Berg CA, Moman MR, van der Heide UA: Difficulties and potential of correlating local recurrences in prostate cancer with the delivered local dose. Radiother Oncol. 2009, 93 (2): 180-184.CrossRefPubMed

71.

De Visschere PJ, De Meerleer GO, Futterer JJ, Villeirs GM: Role of MRI in follow-up after focal therapy for prostate carcinoma. AJR Am J Roentgenol. 2010, 194 (6): 1427-1433.CrossRefPubMed

72.

Kim CK, Park BK, Park W, Kim SS: Prostate MR imaging at 3T using a phased-arrayed coil in predicting locally recurrent prostate cancer after radiation therapy: preliminary experience. Abdom Imaging. 2010, 35 (2): 246-252.CrossRefPubMed

73.

Rouviere O: MR assessment of recurrent prostate cancer after radiation therapy. Radiology. 2007, 242 (2): 635-6. author reply 636-7CrossRefPubMed

74.

Haider MA, Chung P, Sweet J, Toi A, Jhaveri K, Menard C, Warde P, Trachtenberg J, Lockwood G, Milosevic M: Dynamic contrast-enhanced magnetic resonance imaging for localization of recurrent prostate cancer after external beam radiotherapy. Int J Radiat Oncol Biol Phys. 2008, 70 (2): 425-430.CrossRefPubMed

Title: Single blind randomized Phase III trial to investigate the benefit of a focal lesion ablative microboost in prostate cancer (FLAME-trial): study protocol for a randomized controlled trial
Authors: Irene M Lips
Uulke A van der Heide
Karin Haustermans
Emile NJT van Lin
Floris Pos
Stefan PG Franken
Alexis NTJ Kotte
Carla H van Gils
Marco van Vulpen
Publication date: 01-12-2011
Publisher: BioMed Central
Published in: Trials / Issue 1/2011
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/1745-6215-12-255

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Single blind randomized Phase III trial to investigate the benefit of a focal lesion ablative microboost in prostate cancer (FLAME-trial): study protocol for a randomized controlled trial

Abstract

Background

Methods/Design

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/Design

Trial registration

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