Evidence map›Paper›PMID 34774676›Full record

Trial reportInternational journal of radiation oncology, biology, physics2022

SABR for High-Risk Prostate Cancer: A Prospective Multilevel MRI-Based Dose Escalation Trial.

Raquibul Hannan, Samer Salamekh, Neil B Desai, Aurelie Garant, Michael R Folkert, Daniel N Costa, Samantha Mannala, Chul Ahn, Osama Mohamad, Aaron Laine and 10 more

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.8field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 24 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Longitudinal stability of HyperSightScientific reports · 2025
    Article
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  7. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 4 institutions in 1 country.

Raquibul HannanDepartments of Radiation Oncology. Electronic address: Raquibul.Hannan@UTSouthwestern.edu.
Samer SalamekhDepartments of Radiation Oncology.
Neil B DesaiDepartments of Radiation Oncology.
Aurelie GarantDepartments of Radiation Oncology.
Michael R FolkertDepartments of Radiation Oncology.
Daniel N CostaRadiology.
Samantha MannalaDepartments of Radiation Oncology.
Chul AhnPopulation and Data Science, Comprehensive Cancer Center, University of Texas at Southwestern Medical Center, Dallas, Texas.
Osama MohamadDepartment of Radiation Oncology, University of California, San Francisco, California.
Aaron LaineThe Center for Cancer and Blood Disorders, Fort Worth, Texas.
Dong W Nathan KimDepartments of Radiation Oncology.
Tamara DickinsonDepartments of Radiation Oncology.
Ganesh V RajDepartments of Urology.
Rajal B ShahPathology.
Jing WangDepartments of Radiation Oncology.
Xun JiaDepartments of Radiation Oncology.
Hak ChoyDepartments of Radiation Oncology.
Claus G RoehrbornDepartments of Urology.
Yair LotanDepartments of Urology.
Robert D TimmermanDepartments of Radiation Oncology; Neurosurgery, Simmons Comprehensive Cancer Center, University of Texas at Southwestern Medical Center, Dallas, Texas.
Southwestern Medical CenterCenter for Cancer and Blood Disorders · USSouthwestern Medical Center · USUniversity of California, San Francisco · US

Funding

Real-time prostate lesion tracking during SBRTR01EB027898 · NIBIB · UT SOUTHWESTERN MEDICAL CENTER · PI HANNAN, RAQUIBUL, WANG, JING · 2019 to 2022
$1.4M
NIBIB NIH HHS R01 EB027898
6 · The paper itself

Abstract

purposeRadiation dose intensification improves outcome in men with high-risk prostate cancer (HR-PCa). A prospective trial was conducted to determine safety, feasibility, and maximal tolerated dose of multilevel magnetic resonance imaging (MRI)-based 5-fraction SABR in patients with HR-PCa. METHODS AND MATERIALS: This phase I clinical trial enrolled patients with HR-PCa with grade group ≥4, prostate-specific antigen (PSA) ≥20 ng/mL, or radiographic ≥T3, and well-defined prostatic lesions on multiparametric MRI (mpMRI) into 4 dose-escalation cohorts. The initial cohort received 47.5 Gy to the prostate, 50 Gy to mpMRI-defined intraprostatic lesion(s), and 22.5 Gy to pelvic lymph nodes in 5 fractions. Radiation doses were escalated for pelvic nodes to 25 Gy and mpMRI lesion(s) to 52.5 Gy and then 55 Gy. Escalation was performed sequentially according to rule-based trial design with 7 to 15 patients per cohort and a 90-day observation period. All men received peri-rectal hydrogel spacer, intraprostatic fiducial placement, and 2 years of androgen deprivation. The primary endpoint was maximal tolerated dose according to a 90-day acute dose-limiting toxicity (DLT) rate <33%. DLT was defined as National Cancer Institute Common Toxicity Criteria for Adverse Events ≥grade 3 treatment-related toxicity. Secondary outcomes included acute and delayed gastrointestinal (GI)/genitourinary (GU) toxicity graded with Common Toxicity Criteria for Adverse Events.

resultsFifty-five of the 62 enrolled patients were included in the analysis. Dose was escalated through all 4 cohorts without observing any DLTs. Median overall follow-up was 18 months, with a median follow-up of 42, 24, 12, and 7.5 months for cohorts 1 to 4 respectively. Acute and late grade 2 GU toxicities were 25% and 20%, while GI were 13% and 7%, respectively. Late grade 3 GU and GI toxicities were 2% and 0%, respectively.

conclusionsSABR dose for HR-PCa was safely escalated with multilevel dose painting of 47.5 Gy to prostate, 55 Gy to mpMRI-defined intraprostatic lesions, and 25 Gy to pelvic nodal region in 5 fractions. Longer and ongoing follow-up will be required to assess late toxicity.

Indexed as

Prostatic NeoplasmsRadiotherapy, Intensity-ModulatedAndrogen AntagonistsDose Fractionation, RadiationHumansMagnetic Resonance ImagingMaleProspective StudiesAndrogen Antagonists

Identifiers

PMID34774676
PMCPMC9091061
OpenAlexW3212508113

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.