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Phase II trial enzalutamide and androgen deprivation therapy (ADT) with salvage radiation in men with high-risk PSA recurrent prostate cancer (PC): The STREAM trial.

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Armstrong, AJ; Bitting, RL; Healy, P; George, DJ; Kim, S; Mayer, TM; Winters, C; Riggan, C; Rasmussen, J; Wilder, R; Anand, M; Stein, MN ...
Published in: Journal of Clinical Oncology
March 1, 2019

29 Background: Salvage external beam radiotherapy (RT) and hormonal therapy improves survival over RT alone in men with non-metastatic hormone naïve PC and PSA recurrence after radical prostatectomy (RP). We investigated the safety/efficacy of enzalutamide with salvage RT and ADT in this setting. Methods: This was a 3 center prospective phase 2 single arm clinical trial in the Dept of Defense Prostate Cancer Clinical Trials Consortium. Eligibility: Gleason 7-10 PC and PSA recurrence within 4 years (yrs) of RP, PSA 0.2-4.0, no prior hormonal therapy, and no metastases on CT/Bone Scan imaging. Men received 6 months (mos) of ADT with 160 mg/d enzalutamide and 66 Gy RT to the prostate bed. Primary endpoint was 2 yr PFS with testosterone (T) recovery to >100 ng/dl. Secondary objectives included PSA nadir, 3 yr PFS, safety and patient reported quality-of-life over time. This trial was designed with 84% power to detect a 20% improvement in 2 yr PFS vs historic data and a 1-sided alpha of 0.05. Results: We enrolled 38 men (90% white, 8% black, 2% Asian); 37 (97%) completed therapy and were evaluable with T recovery at 2 yrs. Median age was 64 yrs; 47% Gleason 8-10, 79% T3/T4 disease, 21% had resected N+ PC; median PSA was 0.4 (0.19-4.19). Median follow-up is 29.5 mo. Treatment was well tolerated with 11 patients (29%) experiencing G3 toxicities (including 4 HTN, 2 urinary retention, 2 CV events); no G4-5 or unexpected toxicities were observed. T recovery occurred in 35 (95%) at 12 mos. The primary endpoint of 2 yr PFS was 65% (95% CI: 47%-78% vs. historic controls with 51% 2 yr PFS rate) among the 37 patients with T recovery. PSA remained at undetectable levels in 69% at 2 yrs. The 3 yr PFS was 53% (95% CI: 36%, 68%). QOL data over time suggest short term reductions in urinary and sexual function with recovery by 12-24 mo in most men. Conclusions: Salvage enzalutamide and ADT for 6 months with RT following RP for men with PSA recurrent high risk PC is safe, and demonstrates encouraging efficacy at 2 and 3 years. Most men have testosterone recovery at 1 year. These data warrant prospective controlled phase 3 trials to assess the impact of potent AR inhibition in this curative intent setting. Clinical trial information: NCT02057939.

Duke Scholars

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

29 / 29

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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Armstrong, A. J., Bitting, R. L., Healy, P., George, D. J., Kim, S., Mayer, T. M., … Koontz, B. F. (2019). Phase II trial enzalutamide and androgen deprivation therapy (ADT) with salvage radiation in men with high-risk PSA recurrent prostate cancer (PC): The STREAM trial. In Journal of Clinical Oncology (Vol. 37, pp. 29–29). American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.2019.37.7_suppl.29
Armstrong, Andrew J., Rhonda L. Bitting, Patrick Healy, Daniel J. George, Sung Kim, Tina M. Mayer, Carolyn Winters, et al. “Phase II trial enzalutamide and androgen deprivation therapy (ADT) with salvage radiation in men with high-risk PSA recurrent prostate cancer (PC): The STREAM trial.” In Journal of Clinical Oncology, 37:29–29. American Society of Clinical Oncology (ASCO), 2019. https://doi.org/10.1200/jco.2019.37.7_suppl.29.
Armstrong AJ, Bitting RL, Healy P, George DJ, Kim S, Mayer TM, et al. Phase II trial enzalutamide and androgen deprivation therapy (ADT) with salvage radiation in men with high-risk PSA recurrent prostate cancer (PC): The STREAM trial. In: Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2019. p. 29–29.
Armstrong, Andrew J., et al. “Phase II trial enzalutamide and androgen deprivation therapy (ADT) with salvage radiation in men with high-risk PSA recurrent prostate cancer (PC): The STREAM trial.Journal of Clinical Oncology, vol. 37, no. 7_suppl, American Society of Clinical Oncology (ASCO), 2019, pp. 29–29. Crossref, doi:10.1200/jco.2019.37.7_suppl.29.
Armstrong AJ, Bitting RL, Healy P, George DJ, Kim S, Mayer TM, Winters C, Riggan C, Rasmussen J, Wilder R, Anand M, Stein MN, Frizzell B, Harrison MR, Zhang T, Lee WR, Wu Y, Koontz BF. Phase II trial enzalutamide and androgen deprivation therapy (ADT) with salvage radiation in men with high-risk PSA recurrent prostate cancer (PC): The STREAM trial. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2019. p. 29–29.

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

29 / 29

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

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