Evidence map›Paper›PMID 26754260›Full record

Trial reportProstate cancer and prostatic diseases2016

A phase 2 multimodality trial of docetaxel/prednisone with sunitinib followed by salvage radiation therapy in men with PSA recurrent prostate cancer after radical prostatectomy.

A J Armstrong, S Halabi, P Healy, W R Lee, B F Koontz, J W Moul, K Mundy, P Creel, S Wood, K Davis and 11 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Prostate cancer and prostatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.3field-weighted citation impact, top 19% 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

9 citing papers in PubMed, 15 citations in OpenAlex.

  1. MDA-9/Syntenin in the tumor and microenvironment defines prostate cancer bone metastasis.Proceedings of the National Academy of Sciences of the United States of America · 2023
    Article
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Tumor-Associated Macrophages as Target for Antitumor Therapy.Archivum immunologiae et therapiae experimentalis · 2018
    Review
  8. The role of macrophage phenotype in regulating the response to radiation therapy.Translational research : the journal of laboratory and clinical medicine · 2018
    Review
  9. 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

21 authors at 4 institutions in 1 country.

A J ArmstrongDivision of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, NC, USA.
S HalabiDuke Cancer Institute, Duke University, Durham, NC, USA.
P HealyDuke Cancer Institute, Duke University, Durham, NC, USA.
W R LeeDuke Cancer Institute, Duke University, Durham, NC, USA.
B F KoontzDuke Cancer Institute, Duke University, Durham, NC, USA.
J W MoulDivision of Urology, Department of Surgery, Duke University, Durham, NC, USA.
K MundyDuke Cancer Institute, Duke University, Durham, NC, USA.
P CreelDuke Cancer Institute, Duke University, Durham, NC, USA.
S WoodDivision of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, NC, USA.
K DavisDivision of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, NC, USA.
M A CarducciSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
M SteinRutgers Cancer Institute of NJ, New Brunswick, NJ, USA.
C HobbsDuke Cancer Institute, Duke University, Durham, NC, USA.
B ReimerDuke Cancer Institute, Duke University, Durham, NC, USA.
M NguyenDivision of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, NC, USA.
M AnandDuke Cancer Institute, Duke University, Durham, NC, USA.
L BrattDuke Cancer Institute, Duke University, Durham, NC, USA.
S KimRutgers Cancer Institute of NJ, New Brunswick, NJ, USA.
P T TranSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
D J GeorgeDivision of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, NC, USA.
Department of Defense Prostate Cancer Clinical Trials Consortium
Duke University · USDuke Medical Center · USRutgers, The State University of New Jersey · USSidney Kimmel Comprehensive Cancer Center · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
NCI NIH HHS P30 CA006973
6 · The paper itself

Abstract

backgroundIn men with high Gleason PC and rapid PSA progression after surgery, failure rates remain unacceptably high despite salvage radiation. We explored a novel multimodality approach of docetaxel with anti-angiogenic therapy before salvage radiotherapy (RT).

methodsThis was a phase 2 single-arm prospective open-label trial with historic controls. Eligible men had a rising PSA of 0.1-3.0 ng ml(-1) within 4 years of radical prostatectomy, no metastases except resected nodal disease, no prior androgen-deprivation therapy (ADT) and Gleason 7-10. Men received four cycles of docetaxel 70 mg m(-2) every 3 weeks with low dose prednisone and sunitinib 37.5 mg daily for 14/21 days each cycle, with no ADT. Salvage prostate bed RT (66 Gy) started at day 100. The primary end point was progression-free survival (PFS) rate at 24 months. Safety data, quality of life (QOL) and dose-limiting toxicities (DLTs) were measured over time.

resultsThirty-four men accrued in this multi-institutional clinical trial: 24% of men were node positive, 47% were Gleason 8-10, median PSA at entry was 0.54. The trial was terminated prematurely owing to excess DLTs (nine) including grade 3 hand-foot syndrome (n=4), neutropenic fever (n=2), AST increase (n=1), fatigue (n=1) and vomiting with diarrhea (n=1). PFS rate at 24 months was 51% (95% CI: 33, 67%) with a median PFS of 26.2 months (95% CI: 12.5, -). Six men (17.6%) had an undetectable PSA at 2 years.

conclusionsSunitinib and docetaxel/prednisone followed by salvage RT resulted in excess pre-specified DLTs. Although nearly half of the men experienced durable disease control, efficacy was not greater than expected with radiation alone. The use of the intermediate end point of PFS in this salvage setting permitted an early decision on further development of this combination.

Indexed as

AdultAgedDisease-Free SurvivalDocetaxelHumansIndolesKaplan-Meier EstimateMaleMiddle AgedNeoplasm GradingNeoplasm Recurrence, LocalPrednisoneProstatectomyProstate-Specific AntigenProstatic NeoplasmsPyrrolesDocetaxelIndolesPrednisoneProstate-Specific AntigenPyrrolesSunitinibTaxoids

Identifiers

PMID26754260
OpenAlexW2239867761

What OpenQuestion holds

Textmetadata
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.