Evidence map›Paper›PMID 15860850›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2005

Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer.

Matthew R Smith, Fairooz Kabbinavar, Fred Saad, Arif Hussain, Marc C Gittelman, David L Bilhartz, Chris Wynne, Robin Murray, Norman R Zinner, Claude Schulman and 7 more

Registry-linked trialOpen access · bronzeAbstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00005073 (A Randomized Double-Blind Placebo Controlled Phase III Trial Evaluating Zoledronate Plus Standard Therapy Versus Placebo Plus Standard Therapy in Patients With Recurrent Carcinoma of the Prostate Who Are Asymptomatic With Castrate Levels of Testosterone and Have Rising PSA Levels Without Radiologically-Evident Metastatic Disease), which is not on this map. Cited by 198 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
198citing papers in PubMed, 16 pooled it
13.7field-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.

NCT00005073 phase3terminatednot on this map

A Randomized Double-Blind Placebo Controlled Phase III Trial Evaluating Zoledronate Plus Standard Therapy Versus Placebo Plus Standard Therapy in Patients With Recurrent Carcinoma of the Prostate Who Are Asymptomatic With Castrate Levels of Testosterone and Have Rising PSA Levels Without Radiologically-Evident Metastatic Disease

TypeinterventionalSponsorNovartis PharmaceuticalsRan1999 to 2003Enrolled544ConditionsProstate CancerArmszoledronic acid
3 · Its place in the literature

Who cites it

198 citing papers in PubMed, 16 syntheses or guidelines pooled it, 494 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Role of novel hormonal therapies in the management of non-metastatic castration-resistant prostate cancer: a literature-based meta-analysis of randomized trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Guideline
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. SEOM guidelines for the treatment of bone metastases from solid tumours.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2012
    Guideline
  13. NCCN Task Force Report: Bone Health in Cancer Care.Journal of the National Comprehensive Cancer Network : JNCCN · 2009
    Guideline
  14. Guideline
  15. Guideline
  16. Pooled it
  17. Trial
  18. Trial
  19. Trial
  20. Comparison ofBMC medical imaging · 2020
    Trial

138 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 1 institution in 1 country.

Matthew R SmithMassachusetts General Hospital, Cox 640, 100 Blossom St, Boston, MA 02114, USA. smith.matthew@mgh.harvard.edu
Fairooz Kabbinavar
Fred Saad
Arif Hussain
Marc C Gittelman
David L Bilhartz
Chris Wynne
Robin Murray
Norman R Zinner
Claude Schulman
Ronald Linnartz
Ming Zheng
Carsten Goessl
Yong-Jiang Hei
Eric J Small
Richard Cook
Celestia S Higano
University of Maryland, Baltimore · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo describe the natural history of nonmetastatic prostate cancer and rising prostate-specific antigen (PSA) despite androgen deprivation therapy. PATIENTS AND

methodsThe 201 patients in this report were the placebo control group from an aborted randomized controlled trial to evaluate the effects of zoledronic acid on time to first bone metastasis in men with prostate cancer, no bone metastases, and rising PSA despite androgen deprivation therapy. Relationships between baseline covariates and clinical outcomes were assessed by Cox proportional hazard analyses. Covariates in the model were baseline PSA, Gleason sum, history of bilateral orchiectomies, regional lymph node metastases at diagnosis, prior prostatectomy, time from androgen deprivation therapy to random assignment, time from diagnosis to random assignment, and PSA velocity.

resultsAt 2 years, 33% of patients had developed bone metastases. Median bone metastasis-free survival was 30 months. Median time to first bone metastases and overall survival were not reached. Baseline PSA level greater than 10 ng/mL (relative risk, 3.18; 95% CI, 1.74 to 5.80; P < .001) and PSA velocity (4.34 for each 0.01 increase in PSA velocity; 95% CI, 2.30 to 8.21; P < .001) independently predicted shorter time to first bone metastasis. Baseline PSA and PSA velocity also independently predicted overall survival and metastasis-free survival. Other covariates did not consistently predict clinical outcomes.

conclusionMen with nonmetastatic prostate cancer and rising PSA despite androgen deprivation therapy have a relatively indolent natural history. Baseline PSA and PSA velocity independently predict time to first bone metastasis and survival.

Indexed as

AgedAndrogen AntagonistsBiomarkers, TumorBone NeoplasmsDiphosphonatesDisease ProgressionDouble-Blind MethodFollow-Up StudiesHumansImidazolesMalePlacebosPredictive Value of TestsPrognosisProstate-Specific AntigenProstatic NeoplasmsAndrogen AntagonistsBiomarkers, TumorDiphosphonatesImidazolesPlacebosProstate-Specific AntigenZoledronic Acid

Identifiers

PMID15860850
OpenAlexW2150402649

What OpenQuestion holds

Textmetadata
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.