Evidence map›Paper›PMID 34934969›Full record

ArticleEuropean urology open science2021

Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy.

Karen A Autio, Emmanuel S Antonarakis, Tina M Mayer, Daniel H Shevrin, Mark N Stein, Ulka N Vaishampayan, Michael J Morris, Susan F Slovin, Elisabeth I Heath, Scott T Tagawa and 17 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in European urology open science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 4 pooled it
1.5field-weighted citation impact, top 17% 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, 4 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Accelerating Drug Development in Hormone-Naïve Prostate Cancer through Multimodal Therapy Strategies: The MetaCURE Phase 2 Randomized Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
  6. Article
  7. Article
  8. 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

27 authors at 15 institutions in 1 country.

Karen A AutioGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Emmanuel S AntonarakisUniversity of Minnesota Medical School, Minneapolis, MN, USA.
Tina M MayerRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Daniel H ShevrinNorthShore University HealthSystem, Evanston, IL, USA.
Mark N SteinColumbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA.
Ulka N VaishampayanUniversity of Michigan, Ann Arbor, MI, USA.
Michael J MorrisGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Susan F SlovinGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Elisabeth I HeathKarmanos Cancer Institute, Wayne State University, Detroit, MI, USA.
Scott T TagawaWeill Cornell Medical College, New York, NY, USA.
Dana E RathkopfGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Matthew I MilowskyUNC Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Michael R HarrisonDuke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC, USA.
Tomasz M BeerKnight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.
Arjun V BalarNew York University, New York, NY, USA.
Andrew J ArmstrongDuke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC, USA.
Daniel J GeorgeDuke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC, USA.
Channing J PallerJohns Hopkins Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore, MD, USA.
Arlyn ApolloGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Daniel C DanilaGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Julie N GraffKnight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.
Luke NordquistUrology Cancer Center and GU Research Network, Omaha, NE, USA.
Erica S Dayan CohnGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Kin TseColumbia University, New York, NY, USA.
Nicole A SchreiberConvergent Therapeutics, New York, NY, USA.
Glenn HellerBiostatistics Service, Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Howard I ScherGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Memorial Sloan Kettering Cancer Center · USDuke University · USOregon Health & Science University · USColumbia University · USColumbia University Irving Medical Center · USCornell University · USJohns Hopkins University · USNew York University · USNorthShore University HealthSystem · USRutgers, The State University of New Jersey · USUniversity of Michigan · USUniversity of Minnesota Medical Center · USUniversity of North Carolina at Chapel Hill · USUrology Cancer Center and GU Research Network · USWayne State University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundPhase 2 trial endpoints that can be utilized in high-risk biochemical recurrence (BCR) after prostatectomy as a way of more rapidly identifying treatments for phase 3 trials are urgently needed. The efficacy of abiraterone acetate plus prednisone (AAP) in BCR is unknown.

objectiveTo compare the rates of complete biochemical responses after testosterone recovery after 8 mo of AAP and degarelix, a gonadotropin-releasing hormone antagonist, alone or in combination. DESIGN SETTING AND

participantsPatients with BCR (prostate-specific antigen [PSA] ≥1.0 ng/ml, PSA doubling time ≤9 mo, no metastases on standard imaging, and testosterone ≥150 ng/dl) after prostatectomy (with or without prior radiotherapy) were included in this study.

interventionPatients were randomized to AAP (arm 1), AAP with degarelix (arm 2), or degarelix (arm 3) for 8 mo, and monitored for 18 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was undetectable PSA with testosterone >150 ng/dl at 18 mo. Secondary endpoints were undetectable PSA at 8 mo and time to testosterone recovery. RESULTS AND LIMITATIONS: For the 122 patients enrolled, no difference was found between treatments for the primary endpoint (arm 1: 5.1% [95% confidence interval {CI}: 1-17%], arm 2: 17.1% [95% CI: 7-32%], arm 3: 11.9% [95% CI: 4-26%]; arm 1 vs 2,

conclusionsRates of undetectable PSA levels with testosterone recovery were similar between arms, suggesting that increased androgen suppression with AAP and androgen deprivation therapy (ADT) is unlikely to eradicate recurrent disease compared with ADT alone. PATIENT SUMMARY: We evaluated the use of abiraterone acetate plus prednisone (AAP) and androgen deprivation therapy (ADT), AAP alone, or ADT alone in men with biochemically recurrent, nonmetastatic prostate cancer. While more men who received the combination had an undetectable prostate-specific antigen (PSA) level at 8 mo on treatment, once men came off treatment and testosterone level rose, there was no difference in the rates of undetectable PSA levels. This suggests that the combination is not able to eradicate disease any better than ADT alone.

Indexed as

AbirateroneAndrogenAndrogen deprivation therapyBiochemical recurrenceDegarelixProstate cancerProstate-specific antigen

Identifiers

PMID34934969
PMCPMC8655386
OpenAlexW3211854782

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.