Impact of clinical trial participation on survival in patients with castration-resistant prostate cancer: A multi-center analysis

Kyo Chul Koo, Jong Soo Lee, Jong Won Kim, Kyung Suk Han, Kwang Suk Lee, Do Kyung Kim, Yoon Soo Ha, Koon Ho Rha, Sung Joon Hong, Byung Ha Chung

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Clinical trial (CT) participation may confer access to new, potentially active agents before their general availability. This study aimed to investigate the potential survival benefit of participation in investigational CTs of novel hormonal, chemotherapeutic, and radiopharmaceutical agents in patients with castration-resistant prostate cancer (CRPC). Methods: This multi-center, retrospective analysis included 299 consecutive patients with newly diagnosed, non-metastatic or metastatic CRPC between September 2009 and March 2017. Of these, 65 (21.7%) patients participated in CTs pertaining to systemic treatment targeting CRPC and 234 (78.3%) patients received pre-established, standard systemic treatment outside of a CT setting. The survival advantage of CT participation regarding cancer-specific survival (CSS) was investigated. Results: An Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2 at CRPC diagnosis was found in a lower proportion CT participants than in non-participants (4.6% vs. 14.9%; p = 0.033). During the median followup period of 16.0 months, CT participants exhibited significantly higher 2-year CSS survival rates (61.3% vs. 42.4%; p = 0.003) than did non-participants. Multivariate analysis identified prostate-specific antigen and alkaline phosphatase levels at CRPC onset, Gleason score ≥ 8, ECOG PS ≥2, less number of docetaxel cycles administered, and non-participation in CTs as independent predictors for a lower risk of CSS. Conclusions: Patients diagnosed with CRPC who participated in CTs exhibited longer CSS durations than nonparticipants who received pre-established, standard systemic therapy outside of a CT setting. Our findings imply that CT participation is associated with CSS, and that CT participation should be offered to patients with CRPC whenever indicated.

Original languageEnglish
Article number468
JournalBMC cancer
Volume18
Issue number1
DOIs
Publication statusPublished - 2018 Jan 1

Fingerprint

Castration
Prostatic Neoplasms
Clinical Trials
Survival
docetaxel
Neoplasms
Radiopharmaceuticals
Neoplasm Grading
Proxy
Prostate-Specific Antigen
Alkaline Phosphatase
Therapeutics
Multivariate Analysis
Survival Rate

All Science Journal Classification (ASJC) codes

  • Genetics
  • Oncology
  • Cancer Research

Cite this

Koo, Kyo Chul ; Lee, Jong Soo ; Kim, Jong Won ; Han, Kyung Suk ; Lee, Kwang Suk ; Kim, Do Kyung ; Ha, Yoon Soo ; Rha, Koon Ho ; Hong, Sung Joon ; Chung, Byung Ha. / Impact of clinical trial participation on survival in patients with castration-resistant prostate cancer : A multi-center analysis. In: BMC cancer. 2018 ; Vol. 18, No. 1.
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title = "Impact of clinical trial participation on survival in patients with castration-resistant prostate cancer: A multi-center analysis",
abstract = "Background: Clinical trial (CT) participation may confer access to new, potentially active agents before their general availability. This study aimed to investigate the potential survival benefit of participation in investigational CTs of novel hormonal, chemotherapeutic, and radiopharmaceutical agents in patients with castration-resistant prostate cancer (CRPC). Methods: This multi-center, retrospective analysis included 299 consecutive patients with newly diagnosed, non-metastatic or metastatic CRPC between September 2009 and March 2017. Of these, 65 (21.7{\%}) patients participated in CTs pertaining to systemic treatment targeting CRPC and 234 (78.3{\%}) patients received pre-established, standard systemic treatment outside of a CT setting. The survival advantage of CT participation regarding cancer-specific survival (CSS) was investigated. Results: An Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2 at CRPC diagnosis was found in a lower proportion CT participants than in non-participants (4.6{\%} vs. 14.9{\%}; p = 0.033). During the median followup period of 16.0 months, CT participants exhibited significantly higher 2-year CSS survival rates (61.3{\%} vs. 42.4{\%}; p = 0.003) than did non-participants. Multivariate analysis identified prostate-specific antigen and alkaline phosphatase levels at CRPC onset, Gleason score ≥ 8, ECOG PS ≥2, less number of docetaxel cycles administered, and non-participation in CTs as independent predictors for a lower risk of CSS. Conclusions: Patients diagnosed with CRPC who participated in CTs exhibited longer CSS durations than nonparticipants who received pre-established, standard systemic therapy outside of a CT setting. Our findings imply that CT participation is associated with CSS, and that CT participation should be offered to patients with CRPC whenever indicated.",
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Impact of clinical trial participation on survival in patients with castration-resistant prostate cancer : A multi-center analysis. / Koo, Kyo Chul; Lee, Jong Soo; Kim, Jong Won; Han, Kyung Suk; Lee, Kwang Suk; Kim, Do Kyung; Ha, Yoon Soo; Rha, Koon Ho; Hong, Sung Joon; Chung, Byung Ha.

In: BMC cancer, Vol. 18, No. 1, 468, 01.01.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Impact of clinical trial participation on survival in patients with castration-resistant prostate cancer

T2 - A multi-center analysis

AU - Koo, Kyo Chul

AU - Lee, Jong Soo

AU - Kim, Jong Won

AU - Han, Kyung Suk

AU - Lee, Kwang Suk

AU - Kim, Do Kyung

AU - Ha, Yoon Soo

AU - Rha, Koon Ho

AU - Hong, Sung Joon

AU - Chung, Byung Ha

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background: Clinical trial (CT) participation may confer access to new, potentially active agents before their general availability. This study aimed to investigate the potential survival benefit of participation in investigational CTs of novel hormonal, chemotherapeutic, and radiopharmaceutical agents in patients with castration-resistant prostate cancer (CRPC). Methods: This multi-center, retrospective analysis included 299 consecutive patients with newly diagnosed, non-metastatic or metastatic CRPC between September 2009 and March 2017. Of these, 65 (21.7%) patients participated in CTs pertaining to systemic treatment targeting CRPC and 234 (78.3%) patients received pre-established, standard systemic treatment outside of a CT setting. The survival advantage of CT participation regarding cancer-specific survival (CSS) was investigated. Results: An Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2 at CRPC diagnosis was found in a lower proportion CT participants than in non-participants (4.6% vs. 14.9%; p = 0.033). During the median followup period of 16.0 months, CT participants exhibited significantly higher 2-year CSS survival rates (61.3% vs. 42.4%; p = 0.003) than did non-participants. Multivariate analysis identified prostate-specific antigen and alkaline phosphatase levels at CRPC onset, Gleason score ≥ 8, ECOG PS ≥2, less number of docetaxel cycles administered, and non-participation in CTs as independent predictors for a lower risk of CSS. Conclusions: Patients diagnosed with CRPC who participated in CTs exhibited longer CSS durations than nonparticipants who received pre-established, standard systemic therapy outside of a CT setting. Our findings imply that CT participation is associated with CSS, and that CT participation should be offered to patients with CRPC whenever indicated.

AB - Background: Clinical trial (CT) participation may confer access to new, potentially active agents before their general availability. This study aimed to investigate the potential survival benefit of participation in investigational CTs of novel hormonal, chemotherapeutic, and radiopharmaceutical agents in patients with castration-resistant prostate cancer (CRPC). Methods: This multi-center, retrospective analysis included 299 consecutive patients with newly diagnosed, non-metastatic or metastatic CRPC between September 2009 and March 2017. Of these, 65 (21.7%) patients participated in CTs pertaining to systemic treatment targeting CRPC and 234 (78.3%) patients received pre-established, standard systemic treatment outside of a CT setting. The survival advantage of CT participation regarding cancer-specific survival (CSS) was investigated. Results: An Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2 at CRPC diagnosis was found in a lower proportion CT participants than in non-participants (4.6% vs. 14.9%; p = 0.033). During the median followup period of 16.0 months, CT participants exhibited significantly higher 2-year CSS survival rates (61.3% vs. 42.4%; p = 0.003) than did non-participants. Multivariate analysis identified prostate-specific antigen and alkaline phosphatase levels at CRPC onset, Gleason score ≥ 8, ECOG PS ≥2, less number of docetaxel cycles administered, and non-participation in CTs as independent predictors for a lower risk of CSS. Conclusions: Patients diagnosed with CRPC who participated in CTs exhibited longer CSS durations than nonparticipants who received pre-established, standard systemic therapy outside of a CT setting. Our findings imply that CT participation is associated with CSS, and that CT participation should be offered to patients with CRPC whenever indicated.

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