Evidence map›Paper›PMID 38261983›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

PRESTO: A Phase III, Open-Label Study of Intensification of Androgen Blockade in Patients With High-Risk Biochemically Relapsed Castration-Sensitive Prostate Cancer (AFT-19).

Rahul Aggarwal, Glenn Heller, David W Hillman, Han Xiao, Joel Picus, Mary-Ellen Taplin, Tanya Dorff, Leonard Appleman, Douglas Weckstein, Akash Patnaik and 15 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03009981 (A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
16.3field-weighted citation impact, top 1% 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.

NCT03009981 phase3completednot on this map

A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

TypeinterventionalSponsorAlliance Foundation Trials, LLC.Ran2017 to 2025Enrolled504ConditionsProstate CancerArmsApalutamide, LHRH Analogue, Abiraterone Acetate, Prednisone
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Androgen receptor pathway inhibitor intensification in non-metastatic hormone-sensitive prostate cancer: current evidence and clinical implications.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Review
  9. International journal of clinical oncology · 2026
    Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. National Cancer Institute's Working Group on Biochemically Recurrent Prostate Cancer: Clinical Trial Design Considerations.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Article
  16. Article
  17. Review
  18. Review
  19. Optimizing therapy for high-risk biochemically recurrent non-metastatic prostate cancer Current and emerging strategies.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2025
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 19 institutions in 1 country.

Rahul AggarwalUniversity of California, San Francisco, CA.ORCID 0000-0001-7003-7982
Glenn HellerMemorial Sloan Kettering Cancer Center, New York, NY.
David W HillmanMayo Clinic Rochester, Rochester, NY.ORCID 0000-0002-0519-1147
Han XiaoMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0001-5292-5687
Joel PicusWashington University, St. Louis, MO.ORCID 0000-0002-4038-936X
Mary-Ellen TaplinDana-Farber Cancer Institute, Boston, MA.
Tanya DorffCity of Hope, Duarte, CA.ORCID 0000-0001-5990-298X
Leonard ApplemanUniversity of Pittsburgh/UPMC, Pittsburgh, PA.ORCID 0000-0003-4951-7388
Douglas WecksteinNew Hampshire Oncology Hematology, Hooksett, NH.
Akash PatnaikUniversity of Chicago, Chicago, IL.ORCID 0000-0001-5306-0208
Alan BryceMayo Clinic Arizona, Pheonix, AZ.ORCID 0000-0002-0206-3895
Daniel ShevrinNorthShore University HealthSystem, Evanston, IL.ORCID 0000-0001-8426-8888
James MohlerRoswell Park Cancer Center, Buffalo, NY.ORCID 0000-0002-7726-3795
Daniel AndersonHealthPartners, Saint Paul, MN.
Arpit RaoBaylor College of Medicine, Houston, TX.ORCID 0000-0002-5726-4192
Scott TagawaWeill Cornell, New York, NY.ORCID 0000-0003-2777-8587
Alan TanRush University, Chicago, IL.
Susan HalabiDuke University, Durham, NC.ORCID 0000-0003-4135-2777
Katharine DooleyMayo Clinic Rochester, Rochester, NY.ORCID 0000-0003-4565-5767
Patrick O'BrienMayo Clinic Rochester, Rochester, NY.
Ronald ChenUniversity of Kansas, Kansas City, KS.ORCID 0000-0002-4590-8640
Charles J RyanUniversity of Minnesota, Minneapolis, MN.
Scott E EggenerUniversity of Chicago, Chicago, IL.ORCID 0000-0001-6677-2503
Michael J MorrisMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-9454-0096
EORTC-55994 Study Group
Memorial Sloan Kettering Cancer Center · USMayo Clinic · USNew Hampshire Hospital · USUniversity of Chicago · USCity of Hope · USCornell University · USDana-Farber Cancer Institute · USNorthShore University HealthSystem · USRoswell Park Comprehensive Cancer Center · USRush University · USUniversity of California, San Francisco · USUniversity of Minnesota · USUniversity of Pittsburgh · USWashington University in St. Louis · USWinnMed · USBaylor College of Medicine · USDuke University · USHealthPartners · USUniversity of Kansas · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
Targeting the cGAS/STING Pathway to Overcome Resistance to Immune Checkpoint Inhibitors in PTEN-deficient Prostate CancerR01CA273914 · NCI · UNIVERSITY OF CHICAGO · PI PATNAIK, AKASH · 2022 to 2025
$2.6M
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA273914NCI NIH HHS UG1 CA233180
6 · The paper itself

Abstract

purposePatients with biochemically recurrent prostate cancer (BRPC) after radical prostatectomy and a short PSA doubling time are at risk for distant metastases. Apalutamide, an androgen receptor antagonist, and abiraterone acetate plus prednisone (AAP) prolong survival in the metastatic setting. We evaluated whether intensification of androgen-deprivation therapy (ADT) improves outcomes in BRPC. PATIENTS AND

methodsPRESTO is a randomized phase III, open-label trial in patients with BRPC and PSA doubling time ≤9 months (ClinicalTrials.gov identifier: NCT03009981). Patients were randomly assigned 1:1:1 to receive a finite 52-week treatment course with ADT control, ADT + apalutamide, or ADT + apalutamide + AAP. The primary end point was PSA progression-free survival (PSA-PFS), defined as serum PSA >0.2 ng/mL after treatment completion.

resultsFive hundred three patients were enrolled. The median PSA was 1.8 ng/mL (IQR, 1.0-3.6). At the first planned interim analysis, both experimental arms significantly prolonged PSA-PFS compared with the control arm (median, 24.9 months for ADT + apalutamide

conclusionIntensified AR blockade for a finite duration prolongs PSA-PFS with a manageable safety profile, without adversely affecting time to testosterone recovery. The addition of apalutamide to ADT should be considered in patients with high-risk BRPC.

Indexed as

Prostatic NeoplasmsProstatic Neoplasms, Castration-ResistantAbiraterone AcetateAndrogen AntagonistsAndrogensCastrationHumansMalePrednisoneProstate-Specific AntigenTestosteroneAbiraterone AcetateAndrogen AntagonistsAndrogensPrednisoneProstate-Specific AntigenTestosterone

Identifiers

PMID38261983
PMCPMC11637124
OpenAlexW4391168956

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.