Evidence map›Paper›PMID 39032598›Full record

Trial reportPractical radiation oncology

Biochemical Relapse-Free Survival in Postprostatectomy Patients Receiving 18F-Fluciclovine-Guided Prostate Bed-Only Radiation: Post Hoc Analysis of a Prospective Randomized Trial.

Vishal R Dhere, David M Schuster, Subir Goyal, Eduard Schreibmann, Bruce W Hershatter, Sagar A Patel, Joseph W Shelton, Sheela Hanasoge, Pretesh R Patel, Nikhil T Sebastian and 3 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
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. 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.

Vishal R DhereDepartment of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia. Electronic address: vdhere@emory.edu.
David M SchusterDepartment of Radiology and Imaging Sciences, Emory University, Atlanta, Georgia.
Subir GoyalBiostatistics Shared Resource, Winship Cancer Institute, Emory University, Atlanta, Georgia.
Eduard SchreibmannDepartment of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.
Bruce W HershatterDepartment of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.
Sagar A PatelDepartment of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.
Joseph W SheltonDepartment of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.
Sheela HanasogeDepartment of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.
Pretesh R PatelDepartment of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.
Nikhil T SebastianDepartment of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.
Omotayo A AdediranDepartment of Radiology and Imaging Sciences, Emory University, Atlanta, Georgia.
Ismaheel O LawalDepartment of Radiology and Imaging Sciences, Emory University, Atlanta, Georgia.
Ashesh B JaniDepartment of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.

Funding

Winship Cancer Institute Cancer Center Support GrantP30CA138292 · NCI · EMORY UNIVERSITY · PI Suresh S Ramalingam · 2009 to 2026
$47.5M
Molecular Imaging with FACBC PET-CT to Improve Post prostatectomy RadiotherapyR01CA169188 · NCI · EMORY UNIVERSITY · PI JANI, ASHESH, SCHUSTER, DAVID MICHAEL · 2012 to 2016
$2.1M
NCI NIH HHS P30 CA138292NCI NIH HHS R01 CA169188
6 · The paper itself

Abstract

purposeWhole-pelvis (WP) radiation therapy (radiation) improved biochemical relapse-free survival (bRFS) compared with prostate bed (PB)-only radiation in the Radiation Therapy Oncology Group 0534, but was performed in an era prior to positron emission tomography (PET) staging. Separately, 18F-fluciclovine PET/CT-guided postprostatectomy radiation improved 3-year bRFS versus radiation guided by conventional imaging alone. We hypothesized that patients who were changed from WP to PB-only radiation after PET would have bRFS that was: (a) no higher than patients initially planned for PB-only radiation; and (b) lower than patients planned for WP radiation without PET guidance. METHODS AND MATERIALS: We conducted a post hoc analysis of a prospective, randomized trial comparing conventional (arm 1) versus PET-guided (arm 2) postprostatectomy radiation. In arm 2, pre-PET treatment field decisions were recorded and post-PET fields were defined per protocol; pathologic node negative (pN0) without pelvic or extrapelvic PET uptake received PB-only radiation. Three-year bRFS was compared in patients planned for WP with change to PB-only radiation (arm 2 [WP:PB]) vs arm 2 patients planned for PB-only with final radiation to PB-only (arm 2 [PB:PB]) and arm 1 pN0 patients treated with WP radiation (arm 1 [WP]) using the Z test and log-rank test. Demographics were compared using the chi-square test, Fisher exact test, or analysis of variance, as appropriate.

resultsWe identified 10 arm 2 (WP:PB), 31 arm 2 (PB:PB) and 11 arm 1 (WP) patients. Androgen deprivation was used in 50.0% of arm 2 (WP:PB) and 3.2% of arm 2 (PB:PB) patients, P < .01. Median preradiation prostate-specific antigen was higher in arm 2 (WP:PB) vs arm 2 (PB:PB) patients (0.4 vs 0.2 ng/mL, P = .03); however, there were no significant differences in T stage, Gleason score, or margin positivity. Three-year bRFS was 80% in arm 2 (WP:PB) vs 87.4% in arm 2 (PB:PB), P = .47, respectively. Arm 1(WP) patients had significantly worse 3-year (23%) bRFS vs arm 2 (WP:PB), P < .01.

conclusionsPatients initially planned for WP radiation with field decision change to PB-only radiation after PET showed (1) no significant difference in 3-year bRFS compared with patients initially planned for PB-only radiation; and (2) improved bRFS compared with patients receiving WP radiation without PET guidance. PET-guided volume de-escalation in selected patients may be 1 approach to mitigating toxicity without compromising outcomes.

Indexed as

Carboxylic AcidsCyclobutanesProstatectomyProstatic NeoplasmsAgedDisease-Free SurvivalHumansMaleMiddle AgedNeoplasm Recurrence, LocalPositron Emission Tomography Computed TomographyProspective StudiesCarboxylic AcidsCyclobutanesfluciclovine F-18

Identifiers

PMID39032598
PMCPMC12447804

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.