The effect of clinical trial participation versus non-participation on overall survival in men receiving first-line docetaxel-containing chemotherapy for metastatic castration-resistant prostate cancer

Jatinder Goyal, Philipp Nuhn, Peng Huang, Prachi Tyagi, Daniel Oh, Michael A Carducci, Mario Eisenberger, Emmanuel Antonarakis

Research output: Contribution to journalArticle

Abstract

OBJECTIVE • To study differences in baseline characteristics and outcomes of patients with metastatic castration-resistant prostate cancer (mCRPC) receiving first-line docetaxel-containing chemotherapy on prospective clinical studies (trial participants) versus those receiving this therapy outside of a clinical study (non-participants). PATIENTS AND METHODS • Records from 247 consecutive chemotherapy-naive patients who were treated with docetaxel-containing chemotherapy for mCRPC at a single high-volume centre from 1998 to 2010 were reviewed. • All patients received docetaxel either as clinical trial participants ( n = 142; 11 separate studies) or as non-participants ( n = 105). • Univariable and multivariable Cox regression models predicted overall survival after chemotherapy initiation. RESULTS • There was no significant difference between trial participation and nonparticipation with respect to patient age, type of primary treatment, tumour grade or clinical stage. • Multivariable analyses showed a significantly lower risk of all-cause mortality (hazard ratio 0.567; P = 0.027) among trial participants vs non-participants. CONCLUSIONS • Patients that were treated with docetaxel for mCRPC showed a significantly longer overall survival when enrolled in a clinical trial. • Improved survival in trial participants may reflect the better medical oversight typically seen in patients enrolled in trials, more regimented follow-up schedules, or a positive effect on caregivers ' attitudes because of greater contact with medical services. • With the retrospective nature of this analysis and the small study population, prospective studies are needed to validate the present findings and to further investigate the relationship between clinical trial participation and outcomes.

Original languageEnglish (US)
JournalBJU International
Volume110
Issue number11 B
DOIs
StatePublished - Dec 2012

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docetaxel
Castration
Prostatic Neoplasms
Clinical Trials
Drug Therapy
Survival
Prospective Studies
Proportional Hazards Models
Caregivers
Appointments and Schedules

Keywords

  • Chemotherapy
  • Clinical trial
  • Docetaxel
  • Metastatic castration-resistant prostate cancer
  • Overall survival
  • Prostate cancer

ASJC Scopus subject areas

  • Urology

Cite this

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title = "The effect of clinical trial participation versus non-participation on overall survival in men receiving first-line docetaxel-containing chemotherapy for metastatic castration-resistant prostate cancer",
abstract = "OBJECTIVE • To study differences in baseline characteristics and outcomes of patients with metastatic castration-resistant prostate cancer (mCRPC) receiving first-line docetaxel-containing chemotherapy on prospective clinical studies (trial participants) versus those receiving this therapy outside of a clinical study (non-participants). PATIENTS AND METHODS • Records from 247 consecutive chemotherapy-naive patients who were treated with docetaxel-containing chemotherapy for mCRPC at a single high-volume centre from 1998 to 2010 were reviewed. • All patients received docetaxel either as clinical trial participants ( n = 142; 11 separate studies) or as non-participants ( n = 105). • Univariable and multivariable Cox regression models predicted overall survival after chemotherapy initiation. RESULTS • There was no significant difference between trial participation and nonparticipation with respect to patient age, type of primary treatment, tumour grade or clinical stage. • Multivariable analyses showed a significantly lower risk of all-cause mortality (hazard ratio 0.567; P = 0.027) among trial participants vs non-participants. CONCLUSIONS • Patients that were treated with docetaxel for mCRPC showed a significantly longer overall survival when enrolled in a clinical trial. • Improved survival in trial participants may reflect the better medical oversight typically seen in patients enrolled in trials, more regimented follow-up schedules, or a positive effect on caregivers ' attitudes because of greater contact with medical services. • With the retrospective nature of this analysis and the small study population, prospective studies are needed to validate the present findings and to further investigate the relationship between clinical trial participation and outcomes.",
keywords = "Chemotherapy, Clinical trial, Docetaxel, Metastatic castration-resistant prostate cancer, Overall survival, Prostate cancer",
author = "Jatinder Goyal and Philipp Nuhn and Peng Huang and Prachi Tyagi and Daniel Oh and Carducci, {Michael A} and Mario Eisenberger and Emmanuel Antonarakis",
year = "2012",
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T1 - The effect of clinical trial participation versus non-participation on overall survival in men receiving first-line docetaxel-containing chemotherapy for metastatic castration-resistant prostate cancer

AU - Goyal, Jatinder

AU - Nuhn, Philipp

AU - Huang, Peng

AU - Tyagi, Prachi

AU - Oh, Daniel

AU - Carducci, Michael A

AU - Eisenberger, Mario

AU - Antonarakis, Emmanuel

PY - 2012/12

Y1 - 2012/12

N2 - OBJECTIVE • To study differences in baseline characteristics and outcomes of patients with metastatic castration-resistant prostate cancer (mCRPC) receiving first-line docetaxel-containing chemotherapy on prospective clinical studies (trial participants) versus those receiving this therapy outside of a clinical study (non-participants). PATIENTS AND METHODS • Records from 247 consecutive chemotherapy-naive patients who were treated with docetaxel-containing chemotherapy for mCRPC at a single high-volume centre from 1998 to 2010 were reviewed. • All patients received docetaxel either as clinical trial participants ( n = 142; 11 separate studies) or as non-participants ( n = 105). • Univariable and multivariable Cox regression models predicted overall survival after chemotherapy initiation. RESULTS • There was no significant difference between trial participation and nonparticipation with respect to patient age, type of primary treatment, tumour grade or clinical stage. • Multivariable analyses showed a significantly lower risk of all-cause mortality (hazard ratio 0.567; P = 0.027) among trial participants vs non-participants. CONCLUSIONS • Patients that were treated with docetaxel for mCRPC showed a significantly longer overall survival when enrolled in a clinical trial. • Improved survival in trial participants may reflect the better medical oversight typically seen in patients enrolled in trials, more regimented follow-up schedules, or a positive effect on caregivers ' attitudes because of greater contact with medical services. • With the retrospective nature of this analysis and the small study population, prospective studies are needed to validate the present findings and to further investigate the relationship between clinical trial participation and outcomes.

AB - OBJECTIVE • To study differences in baseline characteristics and outcomes of patients with metastatic castration-resistant prostate cancer (mCRPC) receiving first-line docetaxel-containing chemotherapy on prospective clinical studies (trial participants) versus those receiving this therapy outside of a clinical study (non-participants). PATIENTS AND METHODS • Records from 247 consecutive chemotherapy-naive patients who were treated with docetaxel-containing chemotherapy for mCRPC at a single high-volume centre from 1998 to 2010 were reviewed. • All patients received docetaxel either as clinical trial participants ( n = 142; 11 separate studies) or as non-participants ( n = 105). • Univariable and multivariable Cox regression models predicted overall survival after chemotherapy initiation. RESULTS • There was no significant difference between trial participation and nonparticipation with respect to patient age, type of primary treatment, tumour grade or clinical stage. • Multivariable analyses showed a significantly lower risk of all-cause mortality (hazard ratio 0.567; P = 0.027) among trial participants vs non-participants. CONCLUSIONS • Patients that were treated with docetaxel for mCRPC showed a significantly longer overall survival when enrolled in a clinical trial. • Improved survival in trial participants may reflect the better medical oversight typically seen in patients enrolled in trials, more regimented follow-up schedules, or a positive effect on caregivers ' attitudes because of greater contact with medical services. • With the retrospective nature of this analysis and the small study population, prospective studies are needed to validate the present findings and to further investigate the relationship between clinical trial participation and outcomes.

KW - Chemotherapy

KW - Clinical trial

KW - Docetaxel

KW - Metastatic castration-resistant prostate cancer

KW - Overall survival

KW - Prostate cancer

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