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

Karel Decaestecker UGent, Gert De Meerleer UGent, Filip Ameye UGent, VALERIE FONTEYNE, Bieke Lambert UGent, Steven Joniau, LOUKE DELRUE, Ignace Billiet, Wim Duthoy, Sarah Junius, et al. (2014) BMC CANCER. 14.
abstract
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.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
Quality of life, Survival, Androgen deprivation therapy, STEREOTACTIC BODY RADIOTHERAPY, Oligometastases, Prostate cancer, Salvage treatment, Stereotactic body radiotherapy, Salvage lymph node dissection, Active surveillance, ANDROGEN-DEPRIVATION THERAPY, CLINICAL-TRIALS, EAU GUIDELINES, RECOMMENDATIONS, DESIGN, PET/CT
journal title
BMC CANCER
BMC Cancer
volume
14
article number
671
pages
6 pages
Web of Science type
Article
Web of Science id
000342115100001
JCR category
ONCOLOGY
JCR impact factor
3.362 (2014)
JCR rank
81/211 (2014)
JCR quartile
2 (2014)
ISSN
1471-2407
DOI
10.1186/1471-2407-14-671
language
English
UGent publication?
yes
classification
A1
copyright statement
I have retained and own the full copyright for this publication
id
5834444
handle
http://hdl.handle.net/1854/LU-5834444
date created
2015-02-01 15:38:35
date last changed
2017-03-07 09:07:35
@article{5834444,
  abstract     = {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 ({\textlangle}= 3) at recurrence - so called {\textacutedbl}oligometastases{\textacutedbl}. 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 ({\textlangle}= 3 vs. {\textrangle} 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 ({\textrangle}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.},
  articleno    = {671},
  author       = {Decaestecker, Karel and De Meerleer, Gert and Ameye, Filip and FONTEYNE, VALERIE and Lambert, Bieke and Joniau, Steven and DELRUE, LOUKE and Billiet, Ignace and Duthoy, Wim and Junius, Sarah and HUYSSE, WOUTER and Lumen, Nicolaas and Ost, Piet},
  issn         = {1471-2407},
  journal      = {BMC CANCER},
  keyword      = {Quality of life,Survival,Androgen deprivation therapy,STEREOTACTIC BODY RADIOTHERAPY,Oligometastases,Prostate cancer,Salvage treatment,Stereotactic body radiotherapy,Salvage lymph node dissection,Active surveillance,ANDROGEN-DEPRIVATION THERAPY,CLINICAL-TRIALS,EAU GUIDELINES,RECOMMENDATIONS,DESIGN,PET/CT},
  language     = {eng},
  pages        = {6},
  title        = {Surveillance or metastasis-directed Therapy for OligoMetastatic Prostate cancer recurrence (STOMP): study protocol for a randomized phase II trial},
  url          = {http://dx.doi.org/10.1186/1471-2407-14-671},
  volume       = {14},
  year         = {2014},
}

Chicago
Decaestecker, Karel, Gert De Meerleer, Filip Ameye, Valérie Fonteyne, Bieke Lambert, Steven Joniau, LOUKE DELRUE, et al. 2014. “Surveillance or Metastasis-directed Therapy for OligoMetastatic Prostate Cancer Recurrence (STOMP): Study Protocol for a Randomized Phase II Trial.” Bmc Cancer 14.
APA
Decaestecker, K., De Meerleer, G., Ameye, F., Fonteyne, V., Lambert, B., Joniau, S., DELRUE, L., et al. (2014). Surveillance or metastasis-directed Therapy for OligoMetastatic Prostate cancer recurrence (STOMP): study protocol for a randomized phase II trial. BMC CANCER, 14.
Vancouver
1.
Decaestecker K, De Meerleer G, Ameye F, Fonteyne V, Lambert B, Joniau S, et al. Surveillance or metastasis-directed Therapy for OligoMetastatic Prostate cancer recurrence (STOMP): study protocol for a randomized phase II trial. BMC CANCER. 2014;14.
MLA
Decaestecker, Karel, Gert De Meerleer, Filip Ameye, et al. “Surveillance or Metastasis-directed Therapy for OligoMetastatic Prostate Cancer Recurrence (STOMP): Study Protocol for a Randomized Phase II Trial.” BMC CANCER 14 (2014): n. pag. Print.