Evidence map›Paper›PMID 36503429›Full record

Trial reportBMC cancer2022

SPARKLE: a new spark in treating oligorecurrent prostate cancer: adding systemic treatment to stereotactic body radiotherapy or metastasectomy: key to long-lasting event-free survival?

Kato Rans, Berghen Charlien, Ameye Filip, De Hertogh Olivier, den Hartog Julie, Draulans Céderic, Dumez Herlinde, Engels Benedikt, Goffin Karolien, Laenen Annouschka and 8 more

2 registry-linked trialsAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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.

NCT05352178 phase3recruitingnot on this map

a New Spark in Treating Oligorecurrent Prostate Cancer: Adding Systemic Treatment to Stereotactic Body Radiotherapy or Metastasectomy: Key to Long-lasting Event-free Survival?

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2022 to 2032Enrolled873ConditionsProstate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic, Metastatic CancerArmsRadiotherapy (SBRT) and/or surgery (metastasectomy), Androgen deprivation therapy, Androgen receptor targeted therapy
NCT07649421 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Multicenter, Prospective, Randomized Controlled Phase II Trial of PSMA PET/CT-Guided Stereotactic Body Radiotherapy Combined With Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer

TypeinterventionalSponsorWest China HospitalRan2026 to 2031Enrolled254ConditionsMetastatic Hormone-Sensitive Prostate Cancer (mHSPC)ArmsStereotactic Body Radiotherapy (SBRT), Darolutamide 600 mg twice daily, Androgen Deprivation Therapy (ADT)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Stereotactic ablative radiotherapy (SABR) for pelvic nodal oligorecurrence in prostate cancer.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2024
    Article
  6. Review
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

18 authors.

Kato RansDepartment of Radiation Oncology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. kato.rans@uzleuven.be.ORCID http://orcid.org/0000-0002-0389-4041
Berghen CharlienDepartment of Radiation Oncology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.
Ameye FilipDepartment of Urology, AZ Maria Middelares Ghent, Ghent, Belgium.
De Hertogh OlivierDepartment of Radiotherapy, Centre Hospitalier Régional de Verviers, Verviers, Belgium.
den Hartog JulieDepartment of Radiation Oncology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.
Draulans CédericDepartment of Radiation Oncology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.
Dumez HerlindeDepartment of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium.
Engels BenediktDepartment of Radiation Oncology, AZ Delta Roeselare-Menen-Torhout, Roeselare, Belgium.
Goffin KarolienDepartment of Nuclear Medicine and Molecular Imaging, University Hospitals Leuven, Leuven, Belgium.
Laenen AnnouschkaLeuven Biostatistics and Statistical Bioinformatics Center, KU Leuven, Leuven, Belgium.
Liefhooghe NickDepartment of Radiation Oncology, AZ Groeninge, Kortrijk, Belgium.
Poels KennethDepartment of Radiation Oncology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.
Salembier CarlDepartment of Radiotherapy, Europe Hospitals Brussels, Brussels, Belgium.
Slabbaert KoenDepartment of Urology, RZ Tienen, Tienen, Belgium.
Vandendriessche HansDepartment of Urology, AZ Jan Portaels, Vilvoorde, Belgium.
Vanneste BenDepartment of Human Structure and Repair; Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium.
Joniau Steven *Department of Urology, University Hospitals Leuven, Leuven, Belgium.
De Meerleer Gert *Department of Radiation Oncology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetastasis-directed therapy (MDT) significantly delays the initiation of palliative androgen deprivation therapy (pADT) in patients with oligorecurrent prostate cancer (PCa) with a positive impact on patient's quality of life. However, it remains unclear whether the addition of ADT improves polymetastatic free survival (PMFS) and metastatic castration refractory PCa-free survival (mCRPC-FS) and how long concomitant hormone therapy should be given. A significant overall survival (OS) benefit was shown when an androgen receptor targeted agent (ARTA) was added to pADT in patients with metastatic hormone sensitive PCa (HSPC). However, whether the addition of and ARTA to MDT in the treatment of oligorecurrent PCa results in better PMFS and mCRPC-FS has not been proven yet. METHODS &

designPatients diagnosed with oligorecurrent HSPC (defined as a maximum of 5 extracranial metastases on PSMA PET-CT) will be randomized in a 1:1:1 allocation ratio between arm A: MDT alone, arm B: MDT with 1 month ADT, or arm C: MDT with 6 months ADT together with ARTA (enzalutamide 4 × 40 mg daily) for 6 months. Patients will be stratified by PSA doubling time (≤ 3 vs. > 3 months), number of metastases (1 vs. > 1) and initial localization of metastases (M1a vs. M1b and/or M1c). The primary endpoint is PMFS, and the secondary endpoints include mCRPC-FS, biochemical relapse-free survival (bRFS), clinical progression free survival (cPFS), cancer specific survival (CSS), overall survival (OS), quality of life (QOL) and toxicity. DISCUSSION: This is the first prospective multicentre randomized phase III trial that investigates whether the addition of short-term ADT during 1 month or short-term ADT during 6 months together with an ARTA to MDT significantly prolongs PMFS and/or mCRPC-FS.

trial registrationClinicalTrials.gov Identifier: NCT05352178, registered April 28, 2022.

Indexed as

Prostatic NeoplasmsRadiosurgeryAndrogen AntagonistsHormonesHumansMaleNeoplasm Recurrence, LocalPositron Emission Tomography Computed TomographyProgression-Free SurvivalProspective StudiesQuality of LifeAndrogen AntagonistsHormonesAndrogen deprivation therapyAndrogen receptor targeted therapyHormone sensitive prostate cancerMetastasis-directed therapyMetastatic prostate cancerOligorecurrent prostate cancerStereotactic body radiation therapy

Identifiers

PMID36503429
PMCPMC9743623

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.