PEACE V - Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial

被引：72

作者：

De Bruycker, A. ^{[1
]}

Spiessens, A. ^{[1
]}

Dirix, P. ^{[2
]}

Koutsouvelis, N. ^{[3
]}

Semac, I. ^{[3
,4
,5
]}

Liefhooghe, N. ^{[6
]}

Gomez-Iturriaga, A. ^{[7
]}

Everaerts, W. ^{[8
]}

Otte, F. ^{[9
,10
]}

Papachristofilou, A. ^{[11
]}

Scorsetti, M. ^{[12
]}

Shelan, M. ^{[13
]}

Siva, S. ^{[14
]}

Ameye, F. ^{[15
]}

Guckenberger, M. ^{[16
]}

Heikkilae, R. ^{[17
]}

Putora, P. M. ^{[13
,18
]}

Zapatero, A. ^{[19
]}

Conde-Moreno, A. ^{[20
]}

Counago, F. ^{[21
]}

Vanhoutte, F. ^{[1
]}

Goetghebeur, E. ^{[22
]}

Reynders, D. ^{[22
]}

Zilli, T. ^{[3
]}

Ost, P. ^{[1
]}

机构：

[1] Ghent Univ Hosp, Dept Radiat Oncol & Expt Canc Res, Ghent, Belgium

[2] GZ Antwerp, Iridium Canc Network, Dept Radiat Oncol, Antwerp, Belgium

[3] Geneva Univ Hosp, Dept Radiat Oncol, Geneva, Switzerland

[4] Geneva Univ Hosp, Clin Res Ctr, Geneva, Switzerland

[5] Fac Med, Geneva, Switzerland

[6] AZ Groeninge, Dept Radiat Oncol, Kortrijk, Belgium

[7] Cruces Univ Hosp, Biocruces Hlth Res Inst, Baracaldo, Spain

[8] Katholieke Univ Leuven, Dept Dev & Regenerat, Leuven, Belgium

[9] Univ Libre Bruxelles, Univ Clin Brussels, Inst Jules Bordet, Dept Radiat Oncol, Brussels, Belgium

[10] Univ Libre Bruxelles, Univ Clin Brussels, Hop Erasme, Brussels, Belgium

[11] Univ Hosp Basel, Clin Radiotherapy & Radiat Oncol, Basel, Switzerland

[12] IRCSS, Radiotherapy & Radiosurg Dept, Humanitas Clin & Res Hosp, Milan, Italy

[13] Univ Bern, Bern Univ Hosp, Inselspital, Dept Radiat Oncol, Bern, Switzerland

[14] Univ Melbourne, Epworth Healthcare, Melbourne, Vic, Australia

[15] AZ Maria Middelares Ghent, Epworth Healthcare, Ghent, Belgium

[16] Univ Zurich, Dept Radiat Oncol, Univ Hosp Zurich, Zurich, Switzerland

[17] Oslo Univ Hosp, Dept Oncol, Oslo, Norway

[18] Kantonsspital St Gallen, Dept Radiat Oncol, St Gallen, Switzerland

[19] Univ Hosp La Princesa, Madrid, Spain

[20] Hosp Univ & Politecn La Fe, Dept Radiat Oncol, Valencia, Spain

[21] Univ Hosp Quiron, Dept Radiat Oncol, Madrid, Spain

[22] Univ Ghent, Dept Appl Math Comp Sci & Stat, Ghent, Belgium

来源：

BMC CANCER | 2020年 / 20卷 / 01期

关键词：

Prostate cancer; Oligometastases; Oligorecurrence; Stereotactic body radiotherapy; Whole pelvic radiotherapy; Salvage lymph node dissection; Metastasis-directed therapy; Quality of life; Survival; Androgen deprivation therapy; STEREOTACTIC BODY RADIOTHERAPY; RADIATION-THERAPY; ANDROGEN DEPRIVATION; DIRECTED THERAPY; RECURRENCE; GUIDELINES; PROGRESSION; TOMOGRAPHY; CONSENSUS; PET/CT;

D O I：

10.1186/s12885-020-06911-4

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

BackgroundPelvic nodal recurrences are being increasingly diagnosed with the introduction of new molecular imaging techniques, like choline and PSMA PET-CT, in the restaging of recurrent prostate cancer (PCa). At this moment, there are no specific treatment recommendations for patients with limited nodal recurrences and different locoregional treatment approaches are currently being used, mostly by means of metastasis-directed therapies (MDT): salvage lymph node dissection (sLND) or stereotactic body radiotherapy (SBRT). Since the majority of patients treated with MDT relapse within 2 years in adjacent lymph node regions, with an estimated median time to progression of 12-18months, combining MDT with whole pelvic radiotherapy (WPRT) may improve oncological outcomes in these patients. The aim of this prospective multicentre randomized controlled phase II trial is to assess the impact of the addition of WPRT to MDT and short-term androgen deprivation therapy (ADT) on metastasis-free survival (MFS) in the setting of oligorecurrent pelvic nodal recurrence.Methods & designPatients diagnosed with PET-detected pelvic nodal oligorecurrence (<= 5 nodes) following radical local treatment for PCa, will be randomized in a 1:1 ratio between arm A: MDT and 6months of ADT, or arm B: WPRT added to MDT and 6months of ADT. Patients will be stratified by type of PET-tracer (choline, FACBC or PSMA) and by type of MDT (sLND or SBRT). The primary endpoint is MFS and the secondary endpoints include clinical and biochemical progression-free survival (PFS), prostate cancer specific survival, quality of life (QoL), toxicity and time to castration-resistant prostate cancer (CRPC) and to palliative ADT. Estimated study completion: December 31, 2023.DiscussionThis is the first prospective multicentre randomized phase II trial assessing the potential of combined WPRT and MDT as compared to MDT alone on MFS for patients with nodal oligorecurrent PCa.Trial registrationClinicalTrials.gov Identifier: NCT03569241, registered June 14, 2018, ;Identifier on Swiss National Clinical Trials Portal (SNCTP): SNCTP000002947, registered June 14, 2018.

引用

页数：12

共 42 条

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