Evidence map›Paper›PMID 36093342›Full record

ArticleClinical and translational radiation oncology2022

Single fraction of HDR brachytherapy for prostate cancer: Results of the SiFEPI phase II prospective trial.

Jean-Michel Hannoun-Levi, Marie-Eve Chand-Fouche, Tanguy Pace-Loscos, Mathieu Gautier, Jocelyn Gal, Renaud Schiappa, Nina Pujol

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical and translational radiation oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02104362 (A Phase I-II Study to Evaluate Exclusive Single-fraction Irradiation by Interstitial High Dose Rate Brachytherapy in Patients With Prostate Cancer at Low Risk or at Low Intermediate Risk of Local Recurrence), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 20% of its field
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.

NCT02104362 nacompletednot on this map

A Phase I-II Study to Evaluate Exclusive Single-fraction Irradiation by Interstitial High Dose Rate Brachytherapy in Patients With Prostate Cancer at Low Risk or at Low Intermediate Risk of Local Recurrence

TypeinterventionalSponsorCentre Antoine LacassagneRan2014 to 2021Enrolled35ConditionsProstate CancerArmsexclusive single-fraction irradiation
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
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

7 authors at 1 institution in 1 country.

Jean-Michel Hannoun-LeviDepartment of Radiation Oncology, Antoine Lacassagne Cancer Center, University of Côte d'Azur, 33 avenue Valombrose, 06189 Nice Cedex 2, Nice, France.
Marie-Eve Chand-FoucheDepartment of Radiation Oncology, Antoine Lacassagne Cancer Center, University of Côte d'Azur, 33 avenue Valombrose, 06189 Nice Cedex 2, Nice, France.
Tanguy Pace-LoscosDepartment of Statistics, Antoine Lacassagne Cancer Center - University of Côte d'Azur, Nice, France.
Mathieu GautierDepartment of Radiation Oncology, Antoine Lacassagne Cancer Center, University of Côte d'Azur, 33 avenue Valombrose, 06189 Nice Cedex 2, Nice, France.
Jocelyn GalDepartment of Statistics, Antoine Lacassagne Cancer Center - University of Côte d'Azur, Nice, France.
Renaud SchiappaDepartment of Statistics, Antoine Lacassagne Cancer Center - University of Côte d'Azur, Nice, France.
Nina PujolDepartment of Radiation Oncology, Antoine Lacassagne Cancer Center, University of Côte d'Azur, 33 avenue Valombrose, 06189 Nice Cedex 2, Nice, France.
Centre Antoine Lacassagne · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To report the results of the Materials/Methods: The SiFEPI trial (NCT02104362) evaluated a single fraction of high-dose rate brachytherapy (HDB) for low- (LR) and favorable-intermediate (FIR) risk prostate cancers. After rectal spacer placement, a single fraction of 20 Gy was delivered to the prostate. Oncological outcome (biochemical (bRFS) and local (lRFS) relapses, disease-free (DFS) and overall (OS) survivals and toxicity (acute/late genito-urinary (GU), gastro-intestinal (GI) and sexual (S) toxicities were investigated. Results: From 03/2014 to 10/2017, 35 pts were enrolled, of whom 33 were evaluable. With a median age of 66 y [46-79], 25 (76 %) and 8 (24 %) pts were LR and FIR respectively. With a MFU of 72.8 months [64-86], 6y-bRFS, lRFS and mRFS were 62 % [45-85], 61 % [44-85] and 93 % [85-100] respectively while 6y-DFS, CSS and OS were 54 % [37-77], 100 % and 89 % [77-100] respectively. Late GU, GI and S toxicities were observed in 11 pts (33 %;18G1), 4 pts (12 %;4G1) and 7 pts (21 %;1G1,5G2,1G3) respectively. Biochemical relapse (BR) was observed in 11 pts (33 %;7LR,4FIR) with a median time interval between HDB and BR of 51 months [24-69]. Nine of these pts (82 %) presented a histologically proven isolated local recurrence. Conclusions: Long-term results of the SiFEPI trial show that a single fraction of 20 Gy leads to sub-optimal biochemical control for LR/FIR prostate cancers. The late GU and GI toxicity profile is encouraging, leading to consideration of HDB as a safe irradiation technique.

Indexed as

ADT, androgen deprivation therapyBrachytherapybRFS, biochemical relapse free survivalCost-effectivnessCSS, cancer specific survivalCTCAE, common terminology criteria for adverse eventsCT, computerized tomographyCTV, clinical target volumeD90, dose delivered to 90% of the clinical target volumeDFS, disease-free survivalDNR, dose non-homogeneity ratioDVH, dose volume histogramEBRT, external beam radiation therapyEQD2, equivalent dose at 2 Gy per fractionGI, gastro-intestinalGTV1, initial gross volume tumorGTV2, relapse gross volume tumorGU, genito-urinaryHDB, high-dose rate brachytherapyHigh dose rateHR, high riskIIEF, international index of erectile functionIPSS, International prostate symptom scoreIR, intermediate riskISUP, International Society of Urological PathologyITPL, index tumor predominant lesionLDR, low dose-rateLIR, low-intermediate risklRFS, local relapse free survivalLR, low riskMFU, median follow upmpMRI, multi-parametric magnetic resonance imagingmRFS, metastatic relapse-free survivalNCCN, national comprehensive cancer networkOAR, organs at risksOS, overall survivalPC, prostate cancerPET, positron emission tomographyProstate cancerPSA, prostate specific antigenpts, patientsPUF, peak urine flowPVRV, post-void residual volumeQLQC30, quality of life questionnaire cancer patientsQLQ-PR25, quality of life questionnaire for prostate cancerQoL, quality of lifeSBRT, Stereotactic Body Radiation therapySDRT, Single Dose RadiotherapySingle fractionTURP, Transurethral resection of the prostateV100, percentage of the clinical target volume receiving 100% of the prescribed doseV110U, percentage of the urethra volume receiving 110% of the prescribed doseV150, percentage of the clinical target volume receiving 150% of the prescribed doseV200, percentage of the clinical target volume receiving 200% of the prescribed doseV85R, percentage of the rectal volume receiving 85% of the prescribed dose

Identifiers

PMID36093342
PMCPMC9449500
OpenAlexW4293065489

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.