Evidence map›Paper›PMID 33848618›Full record

Trial reportPractical radiation oncology

Long-Term Outcomes of Dose-Escalated Pelvic Lymph Node Intensity-Modulated Radiation Therapy (IMRT) With a Simultaneous Hypofractionated Boost to the Prostate for Very High-Risk Adenocarcinoma of the Prostate: A Prospective Phase II Clinical Trial.

William A Hall, Meena Bedi, Deepak Kilari, Kathryn A Bylow, John Burfeind, Candice Johnstone, Malika Siker, Adam Currey, William A See, Ariel Nelson and 3 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Practical radiation oncology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 36% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. 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 2 institutions in 1 country.

William A HallDepartment of Radiation Oncology. Electronic address: whall@mcw.edu.
Meena BediDepartment of Radiation Oncology.
Deepak KilariDepartment of Medical Oncology.
Kathryn A BylowDepartment of Medical Oncology.
John BurfeindDepartment of Medical Oncology.
Candice JohnstoneDepartment of Radiation Oncology.
Malika SikerDepartment of Radiation Oncology.
Adam CurreyDepartment of Radiation Oncology.
William A SeeDepartment of Urology, Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin.
Ariel NelsonDepartment of Medical Oncology.
Scott JohnsonDepartment of Urology, Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin.
Michael StrazaDepartment of Radiation Oncology.
Colleen A F LawtonDepartment of Radiation Oncology.
Froedtert Hospital · USMajor League Baseball · US

Funding

Institutional Career Development CoreKL2TR001438 · NCATS · MEDICAL COLLEGE OF WISCONSIN · PI WIDLANSKY, MICHAEL E · 2015 to 2024
$2.9M
NCATS NIH HHS KL2 TR001438
6 · The paper itself

Abstract

purposeThere remains limited data as to the feasibility, safety, and efficacy of higher doses of elective radiation therapy to the pelvic lymph nodes in men with high-risk prostate cancer. We conducted a phase II study to evaluate moderate dose escalation to the pelvic lymph nodes using a simultaneous integrated boost to the prostate. METHODS AND MATERIALS: Patients were eligible with biopsy-proven adenocarcinoma of the prostate, a calculated lymph node risk of at least 25%, Karnofsky performance scale ≥70, and no evidence of M1 disease. Acute and late toxicity were prospectively collected at each follow-up using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). The pelvic lymph nodes were treated to a dose of 56 Gy over 28 fractions with a simultaneous integrated boost to the prostate to a total dose of 70 Gy over 28 fractions using intensity-modulated radiation therapy.

resultsThirty patients were prospectively enrolled from October 2010 to August 2014. Median patient age was 70 years (57-83), pretreatment prostate-specific antigen was 11.5 ng/mL (3.23-111.5), T stage was T2c (T1c-T3b), and Gleason score was 9 (6-9). CTCAE v4.0 rate of any grade 1 or 2 genitourinary and gastrointestinal toxicity were 55% and 44%, respectively, and there was 1 reported acute grade 3 genitourinary and gastrointestinal toxicity, both unrelated to protocol therapy. With a median follow-up of 6.4 years, the biochemical failure free survival rate was 80.2%, and mean biochemical progression free survival was 8.3 years (95% confidence interval [CI], 7.2-9.4). The prostate cancer specific survival was 95.2%, and mean prostate cancer specific survival was 8.7 years (95% CI, 8.0-9.4). Five-year distant metastases free survival was 96%. Medians were not reached.

conclusionsIn this single arm, small, prospective feasibility study, nodal radiation therapy dose escalation was safe, feasible, and seemingly well tolerated. Rates of progression free survival are highly encouraging in this population of predominately National Comprehensive Cancer Network very high-risk patients.

Indexed as

AdenocarcinomaProstatic NeoplasmsRadiotherapy, Intensity-ModulatedAgedAged, 80 and overHumansLymph NodesMaleMiddle AgedProspective StudiesProstate

Identifiers

PMID33848618
PMCPMC8638529
OpenAlexW3154447355

What OpenQuestion holds

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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.