Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy

Background: Phase 2 trial endpoints that can be utilized in high-risk biochemical recurrence (BCR) after prostatectomy as a way of more rapidly identifying treatments for phase 3 trials are urgently needed. The efficacy of abiraterone acetate plus prednisone (AAP) in BCR is unknown. Objective: To co...

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Autores principales:	Karen A. Autio, Emmanuel S. Antonarakis, Tina M. Mayer, Daniel H. Shevrin, Mark N. Stein, Ulka N. Vaishampayan, Michael J. Morris, Susan F. Slovin, Elisabeth I. Heath, Scott T. Tagawa, Dana E. Rathkopf, Matthew I. Milowsky, Michael R. Harrison, Tomasz M. Beer, Arjun V. Balar, Andrew J. Armstrong, Daniel J. George, Channing J. Paller, Arlyn Apollo, Daniel C. Danila, Julie N. Graff, Luke Nordquist, Erica S. Dayan Cohn, Kin Tse, Nicole A. Schreiber, Glenn Heller, Howard I. Scher
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Abiraterone Androgen deprivation therapy Androgen Biochemical recurrence Degarelix Prostate cancer Diseases of the genitourinary system. Urology RC870-923 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/7cb29db5a1d04ef391276d51f770d34a
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spelling	oai:doaj.org-article:7cb29db5a1d04ef391276d51f770d34a2021-11-18T04:51:45ZRandomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy2666-168310.1016/j.euros.2021.09.015https://doaj.org/article/7cb29db5a1d04ef391276d51f770d34a2021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2666168321016967https://doaj.org/toc/2666-1683Background: Phase 2 trial endpoints that can be utilized in high-risk biochemical recurrence (BCR) after prostatectomy as a way of more rapidly identifying treatments for phase 3 trials are urgently needed. The efficacy of abiraterone acetate plus prednisone (AAP) in BCR is unknown. Objective: To compare the rates of complete biochemical responses after testosterone recovery after 8 mo of AAP and degarelix, a gonadotropin-releasing hormone antagonist, alone or in combination. Design, setting, and participants: Patients with BCR (prostate-specific antigen [PSA] ≥1.0 ng/ml, PSA doubling time ≤9 mo, no metastases on standard imaging, and testosterone ≥150 ng/dl) after prostatectomy (with or without prior radiotherapy) were included in this study. Intervention: Patients were randomized to AAP (arm 1), AAP with degarelix (arm 2), or degarelix (arm 3) for 8 mo, and monitored for 18 mo. Outcome measurements and statistical analysis: The primary endpoint was undetectable PSA with testosterone >150 ng/dl at 18 mo. Secondary endpoints were undetectable PSA at 8 mo and time to testosterone recovery. Results and limitations: For the 122 patients enrolled, no difference was found between treatments for the primary endpoint (arm 1: 5.1% [95% confidence interval {CI}: 1–17%], arm 2: 17.1% [95% CI: 7–32%], arm 3: 11.9% [95% CI: 4–26%]; arm 1 vs 2, p = 0.93; arm 2 vs 3, p = 0.36). AAP therapy showed the shortest median time to testosterone recovery (36.0 wk [95% CI: 35.9–36.1]) relative to degarelix (52.9 wk [95% CI: 49.0–56.0], p < 0.001). Rates of undetectable PSA at 8 mo differed between AAP with degarelix and degarelix alone (p = 0.04), but not between AAP alone and degarelix alone (p = 0.12). Limitations of this study include a lack of long-term follow-up. Conclusions: Rates of undetectable PSA levels with testosterone recovery were similar between arms, suggesting that increased androgen suppression with AAP and androgen deprivation therapy (ADT) is unlikely to eradicate recurrent disease compared with ADT alone. Patient summary: We evaluated the use of abiraterone acetate plus prednisone (AAP) and androgen deprivation therapy (ADT), AAP alone, or ADT alone in men with biochemically recurrent, nonmetastatic prostate cancer. While more men who received the combination had an undetectable prostate-specific antigen (PSA) level at 8 mo on treatment, once men came off treatment and testosterone level rose, there was no difference in the rates of undetectable PSA levels. This suggests that the combination is not able to eradicate disease any better than ADT alone.Karen A. AutioEmmanuel S. AntonarakisTina M. MayerDaniel H. ShevrinMark N. SteinUlka N. VaishampayanMichael J. MorrisSusan F. SlovinElisabeth I. HeathScott T. TagawaDana E. RathkopfMatthew I. MilowskyMichael R. HarrisonTomasz M. BeerArjun V. BalarAndrew J. ArmstrongDaniel J. GeorgeChanning J. PallerArlyn ApolloDaniel C. DanilaJulie N. GraffLuke NordquistErica S. Dayan CohnKin TseNicole A. SchreiberGlenn HellerHoward I. ScherElsevierarticleAbirateroneAndrogen deprivation therapyAndrogenBiochemical recurrenceDegarelixProstate cancerDiseases of the genitourinary system. UrologyRC870-923Neoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENEuropean Urology Open Science, Vol 34, Iss , Pp 70-78 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Abiraterone Androgen deprivation therapy Androgen Biochemical recurrence Degarelix Prostate cancer Diseases of the genitourinary system. Urology RC870-923 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Abiraterone Androgen deprivation therapy Androgen Biochemical recurrence Degarelix Prostate cancer Diseases of the genitourinary system. Urology RC870-923 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Karen A. Autio Emmanuel S. Antonarakis Tina M. Mayer Daniel H. Shevrin Mark N. Stein Ulka N. Vaishampayan Michael J. Morris Susan F. Slovin Elisabeth I. Heath Scott T. Tagawa Dana E. Rathkopf Matthew I. Milowsky Michael R. Harrison Tomasz M. Beer Arjun V. Balar Andrew J. Armstrong Daniel J. George Channing J. Paller Arlyn Apollo Daniel C. Danila Julie N. Graff Luke Nordquist Erica S. Dayan Cohn Kin Tse Nicole A. Schreiber Glenn Heller Howard I. Scher Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy
description	Background: Phase 2 trial endpoints that can be utilized in high-risk biochemical recurrence (BCR) after prostatectomy as a way of more rapidly identifying treatments for phase 3 trials are urgently needed. The efficacy of abiraterone acetate plus prednisone (AAP) in BCR is unknown. Objective: To compare the rates of complete biochemical responses after testosterone recovery after 8 mo of AAP and degarelix, a gonadotropin-releasing hormone antagonist, alone or in combination. Design, setting, and participants: Patients with BCR (prostate-specific antigen [PSA] ≥1.0 ng/ml, PSA doubling time ≤9 mo, no metastases on standard imaging, and testosterone ≥150 ng/dl) after prostatectomy (with or without prior radiotherapy) were included in this study. Intervention: Patients were randomized to AAP (arm 1), AAP with degarelix (arm 2), or degarelix (arm 3) for 8 mo, and monitored for 18 mo. Outcome measurements and statistical analysis: The primary endpoint was undetectable PSA with testosterone >150 ng/dl at 18 mo. Secondary endpoints were undetectable PSA at 8 mo and time to testosterone recovery. Results and limitations: For the 122 patients enrolled, no difference was found between treatments for the primary endpoint (arm 1: 5.1% [95% confidence interval {CI}: 1–17%], arm 2: 17.1% [95% CI: 7–32%], arm 3: 11.9% [95% CI: 4–26%]; arm 1 vs 2, p = 0.93; arm 2 vs 3, p = 0.36). AAP therapy showed the shortest median time to testosterone recovery (36.0 wk [95% CI: 35.9–36.1]) relative to degarelix (52.9 wk [95% CI: 49.0–56.0], p < 0.001). Rates of undetectable PSA at 8 mo differed between AAP with degarelix and degarelix alone (p = 0.04), but not between AAP alone and degarelix alone (p = 0.12). Limitations of this study include a lack of long-term follow-up. Conclusions: Rates of undetectable PSA levels with testosterone recovery were similar between arms, suggesting that increased androgen suppression with AAP and androgen deprivation therapy (ADT) is unlikely to eradicate recurrent disease compared with ADT alone. Patient summary: We evaluated the use of abiraterone acetate plus prednisone (AAP) and androgen deprivation therapy (ADT), AAP alone, or ADT alone in men with biochemically recurrent, nonmetastatic prostate cancer. While more men who received the combination had an undetectable prostate-specific antigen (PSA) level at 8 mo on treatment, once men came off treatment and testosterone level rose, there was no difference in the rates of undetectable PSA levels. This suggests that the combination is not able to eradicate disease any better than ADT alone.
format	article
author	Karen A. Autio Emmanuel S. Antonarakis Tina M. Mayer Daniel H. Shevrin Mark N. Stein Ulka N. Vaishampayan Michael J. Morris Susan F. Slovin Elisabeth I. Heath Scott T. Tagawa Dana E. Rathkopf Matthew I. Milowsky Michael R. Harrison Tomasz M. Beer Arjun V. Balar Andrew J. Armstrong Daniel J. George Channing J. Paller Arlyn Apollo Daniel C. Danila Julie N. Graff Luke Nordquist Erica S. Dayan Cohn Kin Tse Nicole A. Schreiber Glenn Heller Howard I. Scher
author_facet	Karen A. Autio Emmanuel S. Antonarakis Tina M. Mayer Daniel H. Shevrin Mark N. Stein Ulka N. Vaishampayan Michael J. Morris Susan F. Slovin Elisabeth I. Heath Scott T. Tagawa Dana E. Rathkopf Matthew I. Milowsky Michael R. Harrison Tomasz M. Beer Arjun V. Balar Andrew J. Armstrong Daniel J. George Channing J. Paller Arlyn Apollo Daniel C. Danila Julie N. Graff Luke Nordquist Erica S. Dayan Cohn Kin Tse Nicole A. Schreiber Glenn Heller Howard I. Scher
author_sort	Karen A. Autio
title	Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy
title_short	Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy
title_full	Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy
title_fullStr	Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy
title_full_unstemmed	Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy
title_sort	randomized phase 2 trial of abiraterone acetate plus prednisone, degarelix, or the combination in men with biochemically recurrent prostate cancer after radical prostatectomy
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/7cb29db5a1d04ef391276d51f770d34a
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Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy

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