Surveillance or metastasis-directed Therapy for OligoMetastatic Prostate cancer recurrence (STOMP): study protocol for a randomized phase II trial

BMC Cancer

Karel Decaestecker⁵  Gert De Meerleer³  Filip Ameye⁴  Valerie Fonteyne³  Bieke Lambert²  Steven Joniau¹  Louke Delrue⁷  Ignace Billiet⁹  Wim Duthoy⁸  Sarah Junius⁶  Wouter Huysse⁷  Nicolaas Lumen⁵  Piet Ost³ 

[1] Department of Urology, University Hospitals Leuven, Leuven, Belgium

[2] Department of Nuclear Medicine, Ghent University Hospital, Ghent, Belgium

[3] Department of Radiotherapy, Ghent University Hospital, Ghent, Belgium

[4] Department of Urology, AZ Maria Middelares Gent, Ghent, Belgium

[5] Department of Urology, Ghent University Hospital, Ghent, Belgium

[6] Department of Radiotherapy, CH Mouscron, Mouscron, Belgium

[7] Department of Radiology, Ghent University Hospital, Ghent, Belgium

[8] Department of Radiotherapy, AZ Sint-Lucas Gent, Ghent, Belgium

[9] Department of Urology, AZ Groeninghe, Kortrijk, Belgium

关键词: Survival;    Quality of life;    Androgen deprivation therapy;    Active surveillance;    Salvage lymph node dissection;    Stereotactic body radiotherapy;    Salvage treatment;    Prostate cancer;    Oligometastases;   

Others  :  1121077
DOI  :  10.1186/1471-2407-14-671

 received in 2014-06-06, accepted in 2014-09-02,  发布年份 2014

【 摘 要 】

Background

Metastases-directed therapy (MDT) with surgery or stereotactic body radiotherapy (SBRT) is emerging as a new treatment option for prostate cancer (PCa) patients with a limited number of metastases (≤3) at recurrence – so called “oligometastases”. One of the goals of this approach is to delay the start of palliative androgen deprivation therapy (ADT), with its negative impact on quality of life. However, the lack of a control group, selection bias and the use of adjuvant androgen deprivation therapy prevent strong conclusions from published studies.

The aim of this multicenter randomized phase II trial is to assess the impact of MTD on the start of palliative ADT compared to patients undergoing active surveillance.

Methods/Design

Patients with an oligometastatic recurrence, diagnosed on choline PET/CT after local treatment with curative intent, will be randomised in a 1:1 ratio between arm A: active surveillance only and arm B: MTD followed by active surveillance. Patients will be stratified according to the location of metastasis (node vs. bone metastases) and PSA doubling time (≤3 vs. > 3 months). Both surgery and SBRT are allowed as MDT. Active surveillance means 3-monthly PSA testing and re-imaging at PSA progression. The primary endpoint is ADT-free survival. ADT will be started in both arms at time of polymetastatic disease (>3 metastatic lesions), local progression or symptoms. The secondary endpoints include progression-free survival, quality of life, toxicity and prostate-cancer specific survival.

Discussion

This is the first randomized phase 2 trial assessing the possibility of deferring palliative ADT with MDT in oligometastatic PCa recurrence.

Trial registration

Clinicaltrials.gov identifier: NCT01558427

【 授权许可】

   
2014 Decaestecker et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Heidenreich A, Bastian PJ, Bellmunt J, Bolla M, Joniau S, van der Kwast T, Mason M, Matveev V, Wiegel T, Zattoni F, Mottet N: EAU guidelines on prostate cancer. part II: treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur Urol 2014, 65(2):467-479.
• [2]Abrahamsson PA: Potential benefits of intermittent androgen suppression therapy in the treatment of prostate cancer: a systematic review of the literature. Eur Urol 2010, 57(1):49-59.
• [3]Taylor LG, Canfield SE, Du XL: Review of major adverse effects of androgen-deprivation therapy in men with prostate cancer. Cancer 2009, 115(11):2388-2399.
• [4]Decaestecker K, De Meerleer G, Lambert B, Delrue L, Fonteyne V, Claeys T, De Vos F, Huysse W, Ost P: Repeated stereotactic body radiotherapy for oligometastatic prostate cancer recurrence. Radiat Oncol 2014. in press
• [5]Mottet N, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Schmid HP, Van der Kwast T, Wiegel T, Zattoni F, Heidenreich A: EAU guidelines on prostate cancer. part II: treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur Urol 2011, 59(4):572-583.
• [6]Umbehr MH, Muntener M, Hany T, Sulser T, Bachmann LM: The role of 11C-choline and 18 F-fluorocholine positron emission tomography (PET) and PET/CT in prostate cancer: a systematic review and meta-analysis. Eur Urol 2013, 64(1):106-117.
• [7]Wondergem M, van der Zant FM, van der Ploeg T, Knol RJ: A literature review of 18 F-fluoride PET/CT and 18 F-choline or 11C-choline PET/CT for detection of bone metastases in patients with prostate cancer. Nucl Med Commun 2013, 34(10):935-945.
• [8]Berkovic P, De Meerleer G, Delrue L, Lambert B, Fonteyne V, Lumen N, Decaestecker K, Villeirs G, Vuye P, Ost P: Salvage stereotactic body radiotherapy for patients with limited prostate cancer metastases: deferring androgen deprivation therapy. Clin Genitourin Cancer 2013, 11(1):27-32.
• [9]Suardi N, Gandaglia G, Gallina A, Di Trapani E, Scattoni V, Vizziello D, Cucchiara V, Bertini R, Colombo R, Picchio M, Giovacchini G, Montorsi F, Briganti A: Long-term outcomes of salvage lymph node dissection for clinically recurrent prostate cancer: results of a single-institution series with a minimum follow-up of 5 years. Eur Urol 2014. doi:10.1016/j.eururo.2014.02.011
• [10]Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M, Prostate Cancer Clinical Trials Working Group: Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 2008, 26(7):1148-1159.
• [11]Bottomley A, Flechtner H, Efficace F, Vanvoorden V, Coens C, Therasse P, Velikova G, Blazeby J, Greimel E, European Organisation for Research and Treatment of Cancer: Health related quality of life outcomes in cancer clinical trials. Eur J Cancer 2005, 41(12):1697-1709.
• [12]EuroQol Group: EuroQol--a new facility for the measurement of health-related quality of life. the EuroQol Group. Health Policy 1990, 16(3):199-208.
• [13]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.
• [14]Mitropoulos D, Artibani W, Graefen M, Remzi M, Roupret M, Truss M: Reporting and grading of complications after urologic surgical procedures: an ad hoc EAU guidelines panel assessment and recommendations. Eur Urol 2012, 61(2):341-349.
• [15]Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J: New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45(2):228-247.
• [16]Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ, European Society of Urogenital Radiology: ESUR prostate MR guidelines 2012. Eur Radiol 2012, 22(4):746-757.
• [17]Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF: Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys 2010, 37(8):4078-4101.
• [18]Salama JK, Hasselle MD, Chmura SJ, Malik R, Mehta N, Yenice KM, Villaflor VM, Stadler WM, Hoffman PC, Cohen EE, Connell PP, Haraf DJ, Vokes EE, Hellman S, Weichselbaum RR: Stereotactic body radiotherapy for multisite extracranial oligometastases: final report of a dose escalation trial in patients with 1 to 5 sites of metastatic disease. Cancer 2012, 118(11):2962-2970.
• [19]Casamassima F, Masi L, Menichelli C, Bonucci I, Casamassima E, Lazzeri M, Gulisano M, Aterini S: Efficacy of eradicative radiotherapy for limited nodal metastases detected with choline PET scan in prostate cancer patients. Tumori 2011, 97(1):49-55.
• [20]Bedford JL, Lee YK, Wai P, South CP, Warrington AP: Evaluation of the Delta4 phantom for IMRT and VMAT verification. Phys Med Biol 2009, 54(9):N167-N176.
• [21]Rubinstein LV, Korn EL, Freidlin B, Hunsberger S, Ivy SP, Smith MA: Design issues of randomized phase II trials and a proposal for phase II screening trials. J Clin Oncol 2005, 23(28):7199-7206.
• [22]Palma DA, Haasbeek CJ, Rodrigues GB, Dahele M, Lock M, Yaremko B, Olson R, Liu M, Panarotto J, Griffioen GH, Gaede S, Slotman B, Senan S: Stereotactic ablative radiotherapy for comprehensive treatment of oligometastatic tumors (SABR-COMET): study protocol for a randomized phase II trial. BMC Cancer 2012, 12:305. BioMed Central Full Text
• [23]Palmbos PL, Hussain M: Non-castrate metastatic prostate cancer: have the treatment options changed? Semin Oncol 2013, 40(3):337-346.
• [24]Jilg CA, Rischke HC, Reske SN, Henne K, Grosu AL, Weber W, Drendel V, Schwardt M, Jandausch A, Schultze-Seemann W: Salvage lymph node dissection with adjuvant radiotherapy for nodal recurrence of prostate cancer. J Urol 2012, 188(6):2190-2197.
• [25]Schick U, Jorcano S, Nouet P, Rouzaud M, Vees H, Zilli T, Ratib O, Weber DC, Miralbell R: Androgen deprivation and high-dose radiotherapy for oligometastatic prostate cancer patients with less than five regional and/or distant metastases. Acta Oncol 2013, 52(8):1622-1628.
• [26]Jereczek-Fossa BA, Beltramo G, Fariselli L, Fodor C, Santoro L, Vavassori A, Zerini D, Gherardi F, Ascione C, Bossi-Zanetti I, Mauro R, Bregantin A, Bianchi LC, De Cobelli O, Orecchia R: Robotic image-guided stereotactic radiotherapy, for isolated recurrent primary, lymph node or metastatic prostate cancer. Int J Radiat Oncol Biol Phys 2012, 82(2):889-897.