Evidence map›Paper›PMID 39384104›Full record

ArticleInternational journal of radiation oncology, biology, physics2025

A Phase 1 Trial of Image Guided Risk Volume-Adapted Postprostatectomy Radiation Therapy.

Krishnan R Patel, Esther Mena, Lindsay S Rowe, Holly Ning, Jason Cheng, Kilian Salerno, Erica Schott, Debbie-Ann Nathan, Erich P Huang, Liza Lindenberg and 3 more

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of radiation oncology, biology, physics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Krishnan R PatelRadiation Oncology Branch, National Cancer Institute, National Institutes fo Health, Bethesda, Maryland.
Esther MenaMolecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Lindsay S RoweDepartment of Oncology, University of Alberta, Edmonton, Alberta, Canada.
Holly NingRadiation Oncology Branch, National Cancer Institute, National Institutes fo Health, Bethesda, Maryland.
Jason ChengRadiation Oncology Branch, National Cancer Institute, National Institutes fo Health, Bethesda, Maryland.
Kilian SalernoRadiation Oncology Branch, National Cancer Institute, National Institutes fo Health, Bethesda, Maryland.
Erica SchottRadiation Oncology Branch, National Cancer Institute, National Institutes fo Health, Bethesda, Maryland.
Debbie-Ann NathanRadiation Oncology Branch, National Cancer Institute, National Institutes fo Health, Bethesda, Maryland.
Erich P HuangBiometric Research Program, National Cancer Institute, National Institutes of Health, Rockville, Maryland.
Liza LindenbergMolecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Peter ChoykeMolecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Baris TurkbeyMolecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Deborah E CitrinRadiation Oncology Branch, National Cancer Institute, National Institutes fo Health, Bethesda, Maryland. Electronic address: citrind@mail.nih.gov.

Funding

Mechanisms of Normal Tissue Toxicity From IrradiationZIABC010850 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI CITRIN, DEBORAH · 2009 to 2025
$19.4M
Targeting mechanisms of radiation resistanceZIABC011552 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI CITRIN, DEBORAH · 2014 to 2025
$12.2M
Intramural NIH HHS Z99 CA999999Intramural NIH HHS ZIA BC010850Intramural NIH HHS ZIA BC011552
6 · The paper itself

Abstract

purposeThis was a phase 1 trial with the primary objective of identifying the most compressed dose schedule (DS) tolerable using risk volume-adapted, hypofractionated, postoperative radiation therapy (PORT) for biochemically recurrent prostate cancer. Secondary endpoints included biochemical progression-free survival and quality of life (QOL). METHODS AND MATERIALS: Patients were treated with 1 of 3 isoeffective DSs (DS1: 20 fractions, DS2: 15 fractions, and DS3: 10 fractions) that escalated the dose to the imaging-defined local recurrence (73 Gy

resultsBetween January 2018 and December 2023, 15 patients were treated (3 with DS1, 3 with DS2, and 9 with DS3). The median follow-up was 48 months. No dose-limiting toxicities were observed on any DS, and thus, expansion occurred at DS3. The cumulative incidence of G3 GI and genitourinary toxicity was 7% and 9% at 24 months, respectively, with no G4 events observed. Transient, acute G2+ GI toxicity was the most common. QOL worsened transiently during study follow-up in urinary incontinence, GI, and sexual subdomains but was similar to baseline by 24 months. The biochemical progression-free survival was 91% at both 24 and 60 months.

conclusionsThe maximally tolerated hypofractionated DS for hypofractionated, risk volume-adapted PORT was determined to be DS3 (36.4 Gy to the prostate bed and 47.1 Gy to the imaging-defined recurrence in 10 daily fractions). No >G3 events were observed. Transient declines in QOL did not persist through 24 months.

Indexed as

Neoplasm Recurrence, LocalProstatic NeoplasmsRadiotherapy, Image-GuidedAgedHumansMaleMiddle AgedProgression-Free SurvivalProstatectomyProstate-Specific AntigenQuality of LifeRadiation Dose HypofractionationProstate-Specific Antigen

Identifiers

PMID39384104
PMCPMC11978905

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Registered trials

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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.