Evidence map›Paper›PMID 37608258›Full record

Trial reportBMC cancer2023

Randomized phase II trial of MRI-guided salvage radiotherapy for prostate cancer in 4 weeks versus 2 weeks (SHORTER).

Ariel E Marciscano, Sydney Wolfe, Xi Kathy Zhou, Christopher E Barbieri, Silvia C Formenti, Jim C Hu, Ana M Molina, David M Nanus, Jones T Nauseef, Douglas S Scherr and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04422132 (Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks), which is 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
2.6field-weighted citation impact, top 10% 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.

NCT04422132 phase2active not recruitingnot on this map

Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks

TypeinterventionalSponsorWeill Medical College of Cornell UniversityRan2020 to 2033Enrolled134ConditionsProstate CancerArms5 days Radiation Therapy (32.5 Gy in 5 fractions), 20 days Radiation therapy (55 Gy in 20 fractions)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. 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

13 authors at 3 institutions in 1 country.

Ariel E MarciscanoDepartment of Radiation Oncology, Weill Cornell Medicine/NewYork-Presbyterian, 525 East 68th Street, Box 169, New York, NY, N-046, USA. amarciscano@mgb.org.
Sydney WolfeDepartment of Radiation Oncology, Weill Cornell Medicine/NewYork-Presbyterian, 525 East 68th Street, Box 169, New York, NY, N-046, USA.
Xi Kathy ZhouDepartment of Population Health Sciences, Division of Biostatistics, Weill Cornell Medicine/NewYork-Presbyterian, New York, NY, USA.
Christopher E BarbieriDepartment of Urology, Weill Cornell Medicine/NewYork-Presbyterian, New York, NY, USA.
Silvia C FormentiDepartment of Radiation Oncology, Weill Cornell Medicine/NewYork-Presbyterian, 525 East 68th Street, Box 169, New York, NY, N-046, USA.
Jim C HuDepartment of Urology, Weill Cornell Medicine/NewYork-Presbyterian, New York, NY, USA.
Ana M MolinaEnglander Institute for Precision Medicine, Weill Cornell Medicine/New York-Presbyterian, New York, NY, USA.
David M NanusSandra and Edward Meyer Cancer Center, Weill Cornell Medicine/NewYork-Presbyterian, New York, NY, USA.
Jones T NauseefSandra and Edward Meyer Cancer Center, Weill Cornell Medicine/NewYork-Presbyterian, New York, NY, USA.
Douglas S ScherrDepartment of Urology, Weill Cornell Medicine/NewYork-Presbyterian, New York, NY, USA.
Cora N SternbergEnglander Institute for Precision Medicine, Weill Cornell Medicine/New York-Presbyterian, New York, NY, USA.
Scott T TagawaSandra and Edward Meyer Cancer Center, Weill Cornell Medicine/NewYork-Presbyterian, New York, NY, USA.
Himanshu NagarDepartment of Radiation Oncology, Weill Cornell Medicine/NewYork-Presbyterian, 525 East 68th Street, Box 169, New York, NY, N-046, USA.
Cornell University · USPresbyterian Hospital · USPenn Presbyterian Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUltra-hypofractionated image-guided stereotactic body radiotherapy (SBRT) is increasingly used for definitive treatment of localized prostate cancer. Magnetic resonance imaging-guided radiotherapy (MRgRT) facilitates improved visualization, real-time tracking of targets and/or organs-at-risk (OAR), and capacity for adaptive planning which may translate to improved targeting and reduced toxicity to surrounding tissues. Given promising results from NRG-GU003 comparing conventional and moderate hypofractionation in the post-operative setting, there is growing interest in exploring ultra-hypofractionated post-operative regimens. It remains unclear whether this can be done safely and whether MRgRT may help mitigate potential toxicity. SHORTER (NCT04422132) is a phase II randomized trial prospectively evaluating whether salvage MRgRT delivered in 5 fractions versus 20 fractions is non-inferior with respect to gastrointestinal (GI) and genitourinary (GU) toxicities at 2-years post-treatment.

methodsA total of 136 patients will be randomized in a 1:1 ratio to salvage MRgRT in 5 fractions or 20 fractions using permuted block randomization. Patients will be stratified according to baseline Expanded Prostate Cancer Index Composite (EPIC) bowel and urinary domain scores as well as nodal treatment and androgen deprivation therapy (ADT). Patients undergoing 5 fractions will receive a total of 32.5 Gy over 2 weeks and patients undergoing 20 fractions will receive a total of 55 Gy over 4 weeks, with or without nodal coverage (25.5 Gy over 2 weeks and 42 Gy over 4 weeks) and ADT as per the investigator's discretion. The co-primary endpoints are change scores in the bowel and the urinary domains of the EPIC. The change scores will reflect the 2-year score minus the pre-treatment (baseline) score. The secondary endpoints include safety endpoints, including change in GI and GU symptoms at 3, 6, 12 and 60 months from completion of treatment, and efficacy endpoints, including time to progression, prostate cancer specific survival and overall survival. DISCUSSION: The SHORTER trial is the first randomized phase II trial comparing toxicity of ultra-hypofractionated and hypofractionated MRgRT in the salvage setting. The primary hypothesis is that salvage MRgRT delivered in 5 fractions will not significantly increase GI and GU toxicities when compared to salvage MRgRT delivered in 20 fractions.

trial registrationClinicalTrials.gov Identifier: NCT04422132. Date of registration: June 9, 2020.

Indexed as

Prostatic NeoplasmsRadiotherapy, Image-GuidedAndrogen AntagonistsHumansMagnetic Resonance ImagingMaleProstateAndrogen AntagonistsGenitourinaryHypofractionationMRI-guided radiotherapy (MRgRT)MR-LinacProstate cancerSalvage radiotherapyStereotactic body radiotherapy (SBRT)ToxicityUltra-hypofractionated

Identifiers

PMID37608258
PMCPMC10463903
OpenAlexW4386051170

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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.