Evidence map›Paper›PMID 38523017›Full record

Trial reportEuropean urology oncology2024

Three- and Seven-month Prostate-specific Antigen Levels as Prognostic Markers for Overall Survival in Metastatic Hormone-sensitive Prostate Cancer: Results from SWOG S1216, a Phase 3 Randomized Trial of Androgen Deprivation Plus Orteronel or Bicalutamide.

Mamta Parikh, Catherine Tangen, Maha H A Hussain, Shilpa Gupta, Sam Callis, Yeonjung Jo, Andrea Harzstark, Channing J Paller, Saby George, Matthew R Zibelman and 12 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European urology oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
3.4field-weighted citation impact, top 8% 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

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. 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

22 authors at 17 institutions in 1 country.

Mamta ParikhUC Davis Comprehensive Cancer Center, Sacramento, CA, USA. Electronic address: mbparikh@ucdavis.edu.
Catherine TangenSWOG Statistics and Data Management Center, Seattle, WA, USA.
Maha H A HussainNorthwestern University, Chicago, IL, USA; Robert H Lurie Comprehensive Cancer Center, US.
Shilpa GuptaCleveland Clinic, Cleveland, OH, USA.
Sam CallisSWOG Statistics and Data Management Center, Seattle, WA, USA.
Yeonjung JoUniversity of Utah, Salt Lake City, UT, USA.
Andrea HarzstarkKaiser Permanente San Francisco Medical Center, San Francisco, CA, USA.
Channing J PallerJohns Hopkins University, Baltimore, MD, USA.
Saby GeorgeRoswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Matthew R ZibelmanFox Chase Cancer Center, Philadelphia, PA, USA.
Heather H ChengUniversity of Washington and Fred Hutchinson Cancer Center, Seattle, WA, USA.
Benjamin L MaughanUniversity of Utah, Salt Lake City, UT, USA.
Jingsong ZhangMoffitt Cancer Center, Tampa, FL, USA.
Russell K PachynskiWashington University School of Medicine in St. Louis, St. Louis, MO, USA.
Alan H BryceCity of Hope, Goodyear, AZ, USA.
Daniel W LinUniversity of Washington and Fred Hutchinson Cancer Center, Seattle, WA, USA.
David I QuinnUSC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
Seth P LernerBaylor College of Medicine, Houston, TX, USA.
Ian M ThompsonUniversity of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
Tanya B DorffCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Primo N LaraUC Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Neeraj AgarwalUniversity of Utah, Salt Lake City, UT, USA.
University of Utah · USCity of Hope · USBaylor College of Medicine · USCleveland Clinic · USFox Chase Cancer Center · USFred Hutch Cancer Center · USJohns Hopkins University · USKaiser Permanente San Francisco Medical Center · USMoffitt Cancer Center · USNorthwestern University · USRoswell Park Comprehensive Cancer Center · USThe University of Texas Health Science Center at San Antonio · USUC Davis Comprehensive Cancer CenterUniversity of California, Davis · USUniversity of Washington · USUSC Norris Comprehensive Cancer Center · USWashington University in St. Louis · US

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Gina M Dayton · 2002 to 2026
$84.9M
NCI NIH HHS P30 CA093373NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180888
6 · The paper itself

Abstract

backgroundA robust decrease in prostate-specific antigen (PSA) in response to androgen deprivation therapy (ADT) has been evaluated as a prognostic factor in patients with metastatic hormone-sensitive prostate cancer (mHSPC) since 2006, but the treatment of mHSPC has since evolved to include intensified therapy.

objectiveWe assessed the association of PSA levels at 3 (PSA-3mo) and 7 (PSA-7mo) mo with overall survival (OS) in patients with mHSPC treated with ADT combined with either bicalutamide or orteronel in the S1216 phase 3 clinical trial. DESIGN, SETTING, AND

participantsPSA responses to treatment of patients in the S1216 trial were categorized as: complete response (CR) if PSA was ≤0.2 ng/ml, partial response if PSA was >0.2 and ≤4 ng/ml, and no response (NR) if PSA was >4 ng/ml. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A Cox analysis (adjusted for treatment arm and three stratification factors: performance status, severity of disease, and early vs late induction) was used for OS association. While PSA-7mo association was a prespecified objective, PSA-3mo association was also evaluated. RESULTS AND LIMITATIONS: A total of 1251 and 1231 patients from the S1216 study were evaluable for PSA-3mo and PSA-7mo, respectively. A PSA-7mo CR was associated with improved OS compared with NR (HR: 0.20; p < 0.0001). A PSA-3mo CR showed a similar association to NR (HR: 0.34; p < 0.0001). The association of a PSA response with survival did not differ by treatment arm at either time point.

conclusionsThe PSA-3mo and PSA-7mo responses were strongly associated with OS; taken with other emerging prognostic biomarkers, these markers may allow for early identification of patients at the highest risk of death, aid with counseling in clinical practice, and permit design of future clinical trials targeting these patients. PATIENT SUMMARY: A low prostate-specific antigen level at 3 or 7 mo after starting treatment for metastatic hormone-sensitive prostate cancer predicts longer survival regardless of the first treatment given with androgen deprivation therapy.

Indexed as

Androgen AntagonistsAnilidesNitrilesProstate-Specific AntigenProstatic NeoplasmsTosyl CompoundsAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorHumansMaleMiddle AgedNeoplasm MetastasisPrognosisAndrogen AntagonistsAnilidesbicalutamideBiomarkers, TumorNitrilesProstate-Specific AntigenTosyl CompoundsBiomarkerCastration sensitiveHormone sensitiveProstate cancerProstate-specific antigen

Identifiers

PMID38523017
PMCPMC12037053
OpenAlexW4393109672

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.