Evidence map›Paper›PMID 25223986›Full record

Trial reportBMC cancer2014

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

Karel Decaestecker, Gert De Meerleer, Filip Ameye, Valerie Fonteyne, Bieke Lambert, Steven Joniau, Louke Delrue, Ignace Billiet, Wim Duthoy, Sarah Junius and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01558427 (Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer), which is not on this map. Cited by 66 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01558427 phase2completednot on this map

Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial

TypeinterventionalSponsorUniversity Hospital, GhentRan2012 to 2023Enrolled62ConditionsProstate CancerArmsSurveillance, Salvage treatment
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
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  6. Review
  7. Review
  8. Article
  9. Review
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  13. Prognostic significance of a negative PSMA PET/CT in biochemical recurrence of prostate cancer.Cancer imaging : the official publication of the International Cancer Imaging Society · 2024
    Observational
  14. Article
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  18. Review
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6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Karel Decaestecker
Gert De Meerleer
Filip Ameye
Valerie Fonteyne
Bieke Lambert
Steven Joniau
Louke Delrue
Ignace Billiet
Wim Duthoy
Sarah Junius
Wouter Huysse
Nicolaas Lumen
Piet OstDepartment of Radiotherapy, Ghent University Hospital, Ghent, Belgium. piet.ost@ugent.be.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetastases-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/

designPatients 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 registrationClinicaltrials.gov identifier: NCT01558427.

Indexed as

AdultAgedDisease-Free SurvivalHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalProstate-Specific AntigenProstatic NeoplasmsPublic Health SurveillanceQuality of LifeRadiosurgeryYoung AdultProstate-Specific Antigen

Identifiers

PMID25223986
PMCPMC4175227

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.