Evidence map›Paper›PMID 22931259›Full record

Trial reportThe New England journal of medicine2012

Intermittent androgen suppression for rising PSA level after radiotherapy.

Juanita M Crook, Christopher J O'Callaghan, Graeme Duncan, David P Dearnaley, Celestia S Higano, Eric M Horwitz, Eliot Frymire, Shawn Malone, Joseph Chin, Abdenour Nabid and 11 more

Erratum issued 4 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in The New England journal of medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 217 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
217citing papers in PubMed, 13 pooled it
41.3field-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.

NCT03031821 phase3terminatedstarted 2018, after this paper: background citation

A Randomized Phase 3 Trial of Metformin in Patients Initiating Androgen Deprivation Therapy as Prevention and Intervention of Metabolic Syndrome: The Prime Study

Ran2018Enrolled166Registered outcomes30Posted comparisons0ConditionsMetabolic Syndrome, Prostate CancerArmsMetformin, Placebo Oral Tablet
Open the trial in the graph
NCT00003653 phase3completednot on this map

A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer

TypeinterventionalSponsorNCIC Clinical Trials GroupRan1999 to 2013Enrolled1,386ConditionsProstate CancerArmsbicalutamide, buserelin, cyproterone acetate, flutamide, goserelin
NCT02460549 nacompletednot on this mapstarted 2014, after this paper: background citation

Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation

TypeinterventionalSponsorInstitut de Cancérologie de la LoireRan2014 to 2014Enrolled9ConditionsProstate CancerArmstherapeutic education program
NCT07782112 phase3not yet recruitingnot on this mapstarted 2026, after this paper: background citation

PEACE-9 - ESCALATE-RT: A Phase III Randomized Study in Patients With High-risk PSA Relapse After Local Therapy Treated With Enzalutamide Plus Androgen Deprivation Therapy and Comparing MDT ± Pelvic Radiotherapy Versus no Further Treatment

TypeinterventionalSponsorEnte Ospedaliero Cantonale, BellinzonaRan2026 to 2030Enrolled140ConditionsProstatic Neoplasms, Biochemical Recurrence, Oligometastatic Prostate CancerArmsRadiotherapy for MDT ± WPRT, Androgen Deprivation Therapy (ADT), Enzalutamide
3 · Its place in the literature

Who cites it

217 citing papers in PubMed, 13 syntheses or guidelines pooled it, 490 citations in OpenAlex.

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  4. Guideline
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  8. SEOM clinical guidelines for the treatment of metastatic prostate cancer (2017).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
    Guideline
  9. Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2017
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  14. 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
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157 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 15 institutions in 3 countries.

Juanita M CrookBritish Columbia Cancer Agency, Cancer Centre for the Southern Interior, 399 Royal Ave., Kelowna, BC V1Y 5L3, Canada. jcrook@bccancer.bc.ca
Christopher J O'Callaghan
Graeme Duncan
David P Dearnaley
Celestia S Higano
Eric M Horwitz
Eliot Frymire
Shawn Malone
Joseph Chin
Abdenour Nabid
Padraig Warde
Thomas Corbett
Steve Angyalfi
S Larry Goldenberg
Mary K Gospodarowicz
Fred Saad
John P Logue
Emma Hall
Paul F Schellhammer
Keyue Ding
Laurence Klotz
Queen's University · CABC Cancer Agency · CAInstitute of Cancer Research · CAPrincess Margaret Cancer Centre · CACentre Hospitalier Universitaire de Sherbrooke · CAEastern Virginia Medical School · USFox Chase Cancer Center · USLondon Health Sciences Centre · CAOttawa Regional Cancer Foundation · CASeattle Cancer Care Alliance · USSunnybrook Health Science Centre · CAThe Christie Hospital · GBUniversité de Montréal · CAUniversity of British Columbia · CAUniversity of Toronto · CA

Funding

NCIC Foreign AccrualsU10CA077202 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI EISENHAUER, ELIZABETH · 1998 to 2013
$14.6M
Cancer Research UK 10588NCI NIH HHS CA077202NCI NIH HHS U10 CA077202
6 · The paper itself

Abstract

backgroundIntermittent androgen deprivation for prostate-specific antigen (PSA) elevation after radiotherapy may improve quality of life and delay hormone resistance. We assessed overall survival with intermittent versus continuous androgen deprivation in a noninferiority randomized trial.

methodsWe enrolled patients with a PSA level greater than 3 ng per milliliter more than 1 year after primary or salvage radiotherapy for localized prostate cancer. Intermittent treatment was provided in 8-month cycles, with nontreatment periods determined according to the PSA level. The primary end point was overall survival. Secondary end points included quality of life, time to castration-resistant disease, and duration of nontreatment intervals.

resultsOf 1386 enrolled patients, 690 were randomly assigned to intermittent therapy and 696 to continuous therapy. Median follow-up was 6.9 years. There were no significant between-group differences in adverse events. In the intermittent-therapy group, full testosterone recovery occurred in 35% of patients, and testosterone recovery to the trial-entry threshold occurred in 79%. Intermittent therapy provided potential benefits with respect to physical function, fatigue, urinary problems, hot flashes, libido, and erectile function. There were 268 deaths in the intermittent-therapy group and 256 in the continuous-therapy group. Median overall survival was 8.8 years in the intermittent-therapy group versus 9.1 years in the continuous-therapy group (hazard ratio for death, 1.02; 95% confidence interval, 0.86 to 1.21). The estimated 7-year cumulative rates of disease-related death were 18% and 15% in the two groups, respectively (P=0.24).

conclusionsIntermittent androgen deprivation was noninferior to continuous therapy with respect to overall survival. Some quality-of-life factors improved with intermittent therapy. (Funded by the Canadian Cancer Society Research Institute and others; ClinicalTrials.gov number, NCT00003653.).

Indexed as

AdultAgedAged, 80 and overAndrogen AntagonistsChemotherapy, AdjuvantDrug Administration ScheduleFollow-Up StudiesHumansKaplan-Meier EstimateMaleMiddle AgedPrognosisProportional Hazards ModelsProstate-Specific AntigenProstatic NeoplasmsQuality of LifeAndrogen AntagonistsProstate-Specific AntigenTestosterone

Identifiers

PMID22931259
PMCPMC3521033
OpenAlexW2107270081

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.