drugset / Trial / NCT02903368
Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy
Phase 2
Completed
118 enrolled
Dana-Farber Cancer Institute
Janssen Scientific Affairs, LLC · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This multicenter randomized phase II trial investigates the impact of intense androgen deprivation on radical prostatectomy (RP) pathologic response and radiographic and tissue biomarkers in localized prostate cancer (NCT02903368).
Timeline
- Start
- 2016-10-19
- Primary completion
- 2022-04-05
- Completion
- 2024-07-10
Publications
- Lin HM, Yang X, Centenera MM, Huynh K, Giles C, Dehairs J, Swinnen JV, Hoy AJ, Meikle PJ, Butler LM, Taplin ME, Horvath LG. Circulating Lipid Profiles Associated With Resistance to Androgen Deprivation Therapy in Localized Prostate Cancer. JCO Precis Oncol. 2024 Jul;8:e2400260. doi: 10.1200/PO.24.00260.
- McKay RR, Xie W, Yang X, Acosta A, Rathkopf D, Laudone VP, Bubley GJ, Einstein DJ, Chang P, Wagner AA, Kane CJ, Preston MA, Kilbridge K, Chang SL, Choudhury AD, Pomerantz MM, Trinh QD, Kibel AS, Taplin ME. Postradical prostatectomy prostate-specific antigen outcomes after 6 versus 18 months of perioperative androgen-deprivation therapy in men with localized, unfavorable intermediate-risk or high-risk prostate cancer: Results of part 2 of a randomized phase 2 trial. Cancer. 2024 May 1;130(9):1629-1641. doi: 10.1002/cncr.35170. Epub 2024 Jan 1.
- McKay RR, Xie W, Ye H, Fennessy FM, Zhang Z, Lis R, Calagua C, Rathkopf D, Laudone VP, Bubley GJ, Einstein DJ, Chang PK, Wagner AA, Parsons JK, Preston MA, Kilbridge K, Chang SL, Choudhury AD, Pomerantz MM, Trinh QD, Kibel AS, Taplin ME. Results of a Randomized Phase II Trial of Intense Androgen Deprivation Therapy prior to Radical Prostatectomy in Men with High-Risk Localized Prostate Cancer. J Urol. 2021 Jul;206(1):80-87. doi: 10.1097/JU.0000000000001702. Epub 2021 Mar 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 240 mg | Oral |
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Subject | Apalutamide | Small molecule | 1000 mg | Oral |
| Subject | Leuprolide | Other / unclassified | 22.5 mg | Intramuscular |
| Subject | Prednisone | Other / unclassified | 5 mg | Oral |