Evidence map›Paper›PMID 32562839›Full record

ArticleInternational journal of radiation oncology, biology, physics2020

Phase 1 Trial of Stereotactic Body Radiation Therapy Neoadjuvant to Radical Prostatectomy for Patients With High-Risk Prostate Cancer.

Neil R Parikh, Amar U Kishan, Nathanael Kane, Silvia Diaz-Perez, Ekambaram Ganapathy, Ramin Nazarian, Carol Felix, Colleen Mathis, Margaret Bradley, Ankush Sachdeva and 14 more

Open access · greenAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of radiation oncology, biology, physics, 2020. 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
1.8field-weighted citation impact, top 12% 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, 16 citations in OpenAlex.

  1. Trial
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  4. Article
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  7. Review
  8. Phase I dose escalation trial of stereotactic radiotherapy prior to robotic prostatectomy in high risk prostate cancer.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2021
    Article
  9. Article
  10. 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

24 authors at 2 institutions in 1 country.

Neil R ParikhDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California.
Amar U KishanDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California; Department of Urology, University of California Los Angeles, Los Angeles, California.
Nathanael KaneDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California.
Silvia Diaz-PerezDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California.
Ekambaram GanapathyDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California.
Ramin NazarianDepartment of Urology, University of California Los Angeles, Los Angeles, California.
Carol FelixDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California.
Colleen MathisDepartment of Urology, University of California Los Angeles, Los Angeles, California.
Margaret BradleyDepartment of Urology, University of California Los Angeles, Los Angeles, California.
Ankush SachdevaDepartment of Urology, University of California Los Angeles, Los Angeles, California.
Bashir WyattDepartment of Urology, University of California Los Angeles, Los Angeles, California.
Vince BasehartDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California.
Nazy ZomorodianDepartment of Urology, University of California Los Angeles, Los Angeles, California.
Lin LinDepartment of Urology, University of California Los Angeles, Los Angeles, California.
Christopher R KingDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California.
Patrick A KupelianDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California.
Matthew B RettigDepartment of Urology, University of California Los Angeles, Los Angeles, California.
Michael L SteinbergDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California.
Minsong CaoDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California.
Beatrice S KnudsenDepartments of Pathology and Laboratory Medicine and Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, California.
David ElashoffDepartment of Medicine, University of California Los Angeles, Los Angeles, California.
Dorthe SchaueDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California.
Robert E ReiterDepartment of Urology, University of California Los Angeles, Los Angeles, California.
Nicholas G NickolsDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, California; Department of Urology, University of California Los Angeles, Los Angeles, California; Radiation Therapy Service, VA Greater Los Angeles Healthcare System, Los Angeles, California. Electronic address: nnickols@mednet.ucla.edu.
University of California, Los Angeles · USCedars-Sinai Medical Center · US

Funding

Women's CancersP30CA016042 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Melissa Fitzmaurice Neligan · 1985 to 2026
$134.5M
UCLA SPORE IN PROSTATE CANCERP50CA092131 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI REITER, ROBERT E · 2002 to 2023
$42.6M
NCI NIH HHS P30 CA016042NCI NIH HHS P50 CA092131
6 · The paper itself

Abstract

purposeThis study aimed to evaluate the feasibility and safety of prostate stereotactic body radiation therapy (SBRT) neoadjuvant to radical prostatectomy (RP) in a phase 1 trial. The primary endpoint was treatment completion rate without severe acute surgical complications. Secondary endpoints included patient-reported quality of life and physician-reported toxicities. METHODS AND MATERIALS: Patients with nonmetastatic high-risk or locally advanced prostate cancer received 24 Gy in 3 fractions to the prostate and seminal vesicles over 5 days, completed 2 weeks before RP. Patients with pN1 disease were treated after multidisciplinary discussion and shared decision making. Patient-reported quality of life (International Prostate Symptom Score and Expanded Prostate Cancer Index Composite 26-item version questionnaires) and physician-reported toxicity (Common Terminology Criteria for Adverse Events, version 4.03) were assessed before SBRT, immediately before surgery, and at 3-month intervals for 1 year.

resultsTwelve patients were enrolled, and 11 completed treatment (1 patient had advanced disease on prostate-specific membrane antigen positron emission tomography after enrollment but before treatment). There were no significant surgical complications. After RP, 2 patients underwent additional radiation therapy to nodes with androgen suppression for pN1 disease. Median follow-up after completion of treatment was 20.1 months, with 9 of 11 patients having a follow-up period of >12 months. Two patients had biochemical recurrence (prostate-specific antigen ≥0.05) within the first 12 months, with an additional 2 patients found to have biochemical recurrence after the 12-month period. The highest Common Terminology Criteria for Adverse Events genitourinary grades were 0, 1, 2, and 3 (n = 1, 4, 4, and 2, respectively), and the highest gastrointestinal grades were 0, 1, and 2 (n = 9, 1, and 1, respectively). At 12 months, incontinence was the only grade ≥2 toxicity. One and 2 of 9 patients had grade 2 and 3 incontinence, respectively. On the Expanded Prostate Cancer Index Composite (26-item version), the mean/median changes in scores from baseline to 12 months were -32.8/-31.1 for urinary incontinence, -1.6/-6.2 for urinary irritative/obstructive, -2.1/0 for bowel, -34.4/-37.5 for sexual function, and -10.6/-2.5 for hormonal. The mean/median change in International Prostate Symptom Score from baseline to 12 months was 0.5/0.5.

conclusionsRP after neoadjuvant SBRT appears to be feasible and safe at the dose tested. The severity of urinary incontinence may be higher than RP alone.

Indexed as

ProstatectomyRadiosurgeryFeasibility StudiesFollow-Up StudiesHumansMaleNeoadjuvant TherapyProstateProstatic NeoplasmsQuality of LifeSeminal VesiclesUrinary Incontinence

Identifiers

PMID32562839
PMCPMC8261839
OpenAlexW3036833858

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.