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PROPEL: A randomized, phase III trial evaluating the efficacy and safety of olaparib combined with abiraterone as first-line therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).

Publication ,  Conference
Clarke, NW; Armstrong, AJ; Thiery-Vuillemin, A; Oya, M; Ye, D; Mateo, J; Goessl, CD; Kang, J; Liu, S; Saad, F
Published in: Journal of Clinical Oncology
March 1, 2019

TPS340 Background: A Phase II trial showed olaparib (tablets, 300 mg bid) in combination with abiraterone (1000 mg od plus prednisone/prednisolone 5 mg bid) significantly prolonged radiologic progression-free survival (rPFS) compared with abiraterone alone (median 13.8 vs 8.2 months; hazard ratio 0.65, 95% CI 0.44–0.97, P=0.034) in patients (pts) with mCRPC in the second-line metastatic setting who received prior docetaxel (Clarke et al. Lancet Oncol 2018). Treatment benefits were achieved irrespective of homologous recombination repair (HRR) mutation status, suggesting potential synergy between the two treatments that could impact a broader patient population. PROpel (EudraCT: 2018-002011-10) is the follow-on study to this, and the first Phase III trial to assess a PARP inhibitor in combination with abiraterone as first-line treatment in a genetically unselected mCRPC pt population. Methods: PROpel is a double-blind, placebo-controlled, international, multicenter study of pts randomized (1:1), as for the Phase II trial, to abiraterone (1000 mg od plus prednisone/prednisolone 5 mg bid) plus either olaparib (tablets, 300 mg bid) or placebo. Pts must not have received prior chemotherapy, new hormonal agents or other systemic treatment at mCRPC stage (except docetaxel at metastatic hormone-sensitive prostate cancer stage [mHSPC]). Randomization is stratified according to site of metastases (bone only vs visceral vs other) and docetaxel treatment at mHSPC stage (yes, no). The primary endpoint is investigator-assessed rPFS (RECIST v1.1 [soft tissue] and Prostate Working Cancer Group 3 [PCWG-3 criteria; bone]). Secondary objectives include time to first subsequent therapy or death, time to pain progression, overall survival, and health-related quality of life. Safety and tolerability will also be described. Exploratory endpoints include HRR subgroup analyses to confirm that efficacy is independent of HRR status. Screening across ~200 sites in 20 countries is being conducted to identify a target sample of ~720 pts. Enrollment is expected to begin in October 2018. (Study 8, NCT01972217). Clinical trial information: NCT03732820.

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Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

March 1, 2019

Volume

37

Issue

7_suppl

Start / End Page

TPS340 / TPS340

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

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MLA
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Clarke, N. W., Armstrong, A. J., Thiery-Vuillemin, A., Oya, M., Ye, D., Mateo, J., … Saad, F. (2019). PROPEL: A randomized, phase III trial evaluating the efficacy and safety of olaparib combined with abiraterone as first-line therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). In Journal of Clinical Oncology (Vol. 37, pp. TPS340–TPS340). American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.2019.37.7_suppl.tps340
Clarke, Noel W., Andrew J. Armstrong, Antoine Thiery-Vuillemin, Mototsugu Oya, Dingwei Ye, Joaquin Mateo, Carsten Dietrich Goessl, Jinyu Kang, Sherry Liu, and Fred Saad. “PROPEL: A randomized, phase III trial evaluating the efficacy and safety of olaparib combined with abiraterone as first-line therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).” In Journal of Clinical Oncology, 37:TPS340–TPS340. American Society of Clinical Oncology (ASCO), 2019. https://doi.org/10.1200/jco.2019.37.7_suppl.tps340.
Clarke NW, Armstrong AJ, Thiery-Vuillemin A, Oya M, Ye D, Mateo J, et al. PROPEL: A randomized, phase III trial evaluating the efficacy and safety of olaparib combined with abiraterone as first-line therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). In: Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2019. p. TPS340–TPS340.
Clarke, Noel W., et al. “PROPEL: A randomized, phase III trial evaluating the efficacy and safety of olaparib combined with abiraterone as first-line therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).Journal of Clinical Oncology, vol. 37, no. 7_suppl, American Society of Clinical Oncology (ASCO), 2019, pp. TPS340–TPS340. Crossref, doi:10.1200/jco.2019.37.7_suppl.tps340.
Clarke NW, Armstrong AJ, Thiery-Vuillemin A, Oya M, Ye D, Mateo J, Goessl CD, Kang J, Liu S, Saad F. PROPEL: A randomized, phase III trial evaluating the efficacy and safety of olaparib combined with abiraterone as first-line therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2019. p. TPS340–TPS340.

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

March 1, 2019

Volume

37

Issue

7_suppl

Start / End Page

TPS340 / TPS340

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences