Evidence map›Paper›PMID 36420197›Full record

ArticleAdvances in radiation oncology

A Phase 1 Trial of Highly Conformal, Hypofractionated Postprostatectomy Radiation Therapy.

Krishnan R Patel, Lindsay S Rowe, Erica Schott, Theresa Cooley-Zgela, Holly Ning, Baris Turkbey, Peter Choyke, Liza Lindenberg, Esther Mena, Peter A Pinto and 4 more

Open access · goldAbstract read
In one paragraph

Article in Advances in radiation oncology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 30% 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, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. A Phase 1 Trial of Image Guided Risk Volume-Adapted Postprostatectomy Radiation Therapy.International journal of radiation oncology, biology, physics · 2025
    Article
  3. 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

14 authors at 1 institution in 1 country.

Krishnan R PatelRadiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Lindsay S RoweRadiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Erica SchottRadiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Theresa Cooley-ZgelaRadiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Holly NingRadiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Baris TurkbeyMolecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Peter ChoykeMolecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Liza LindenbergMolecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Esther MenaMolecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Peter A PintoUrologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Qihu ZhangDivision of Cancer Treatment and Diagnosis: Biometric Research Program, National Cancer Institute, National Institutes of Health, Rockville, Maryland.
Joanna ShihDivision of Cancer Treatment and Diagnosis: Biometric Research Program, National Cancer Institute, National Institutes of Health, Rockville, Maryland.
Kilian E SalernoRadiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Deborah E CitrinRadiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
National Institutes of Health · US

Funding

Targeting mechanisms of radiation resistanceZIABC011552 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI CITRIN, DEBORAH · 2014 to 2025
$12.2M
Intramural NIH HHS ZIA BC011552
6 · The paper itself

Abstract

Purpose: This phase 1 trial aimed to identify the maximally tolerated hypofractionated dose schedule for postoperative radiation therapy (PORT) after radical prostatectomy. Secondary objectives included biochemical control and quality of life (QoL) measures. Methods and Materials: Patients were treated on 1 of 3 dose levels (DLs): 56.4 Gy in 20 fractions (DL1), 51.2 Gy in 15 fractions (DL2), and 44.2 Gy in 10 fractions (DL3). Treatment was delivered to the prostate bed without pelvic nodal irradiation. Dose escalation followed a standard 3 + 3 design with an expansion for 6 additional patients at the maximally tolerated hypofractionated dose schedule. Acute dose-limiting toxicity (DLT) was defined as grade 3 toxicity lasting >4 days within 21 days of PORT completion; late DLT was defined as grade 4 gastrointestinal (GI) or genitourinary (GU) toxicity. Results: Between January 2018 and August 2019, 15 patients underwent radiation treatment: 3 on DL1, 3 on DL2, and 9 on DL3. The median follow-up was 24 months. There were no DLTs, and the maximally tolerated hypofractionated dose schedule was identified as DL3. Two of the 15 patients (13.3%) experienced biochemical failure (prostate-specific antigen >0.1). Ten of 15 patients (67%) had grade 2+ acute toxicities, consisting of transient GI toxicities. Three patients experienced late grade 2+ GI toxicity, and 5 patients experienced late grade 2+ GU toxicity. Late grade 3 GU toxicity occurred in 2 patients. There were no grade 4+ acute or late toxicities. There were no significant differences in GI measures of QoL, however, there was an increase in GU symptoms and corresponding decrease in GU QoL between 12 and 24 months. Conclusions: The maximum tolerated hypofractionated dose schedule for hypofractionated PORT to the prostate bed was determined to be 44.2 Gy in 10 daily fractions. The most frequent clinically significant toxicities were late grade 2+ GU toxicities, which corresponded to a worsening of late GU QoL.

Identifiers

PMID36420197
PMCPMC9677208
OpenAlexW4285603520

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.