Intense ADT before prostatectomy. - Advanced Prostate...

Advanced Prostate Cancer

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Intense ADT before prostatectomy.

pjoshea13 profile image
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New study below [1]. Of academic interest to the group, but useful to others we might know, perhaps.

Phase II study with 75 men & 19 co-authors!

"Eligible patients had a biopsy Gleason score of 4 + 3 = 7 or greater, prostate-specific antigen (PSA) greater than 20 ng/mL, or T3 disease ... Lymph nodes were required to be smaller than 20 mm. Patients were randomly assigned 2:1 to ELAP {enzalutamide and leuprolide with abiraterone + prednisone} or EL {enzalutamide and leuprolide} for 24 weeks followed by RP {radical prostatectomy}."

"The pathologic complete response or minimal residual disease rate was 30% (n = 15 of 50) in ELAP-treated patients and 16% (n = four of 25) in EL-treated patients ..."

"Tumor ERG positivity and PTEN loss were associated with more extensive residual tumors at RP."

"Neoadjuvant hormone therapy followed by RP in locally advanced prostate cancer resulted in favorable pathologic responses in some patients, with a trend toward improved pathologic outcomes with ELAP. Longer follow-up is necessary to evaluate the impact of therapy on recurrence rates.* The potential association of ERG and PTEN alterations with worse outcomes warrants additional investigation."

* my emphasis

-Patrick

ascopubs.org/doi/full/10.12...

Evaluation of Intense Androgen Deprivation Before Prostatectomy: A Randomized Phase II Trial of Enzalutamide and Leuprolide With or Without Abiraterone

Rana R. McKay, MD12; Huihui Ye, MD3; Wanling Xie, MS2; Rosina Lis, MD2; Carla Calagua, MD3; Zhenwei Zhang, MD, PhD2; Quoc-Dien Trinh, MD2; Steven L. Chang, MD2; Lauren C. Harshman, MD2; Ashley E. Ross, MD, PhD4; Kenneth J. Pienta, MD4; Daniel W. Lin, MD5; William J. Ellis, MD5; Bruce Montgomery, MD5; Peter Chang, MD, MPH3; Andrew A. Wagner, MD3; Glenn J. Bubley, MD3; Adam S. Kibel, MD2; and Mary-Ellen Taplin, MD2 1University of California, San Diego, San Diego, CA

2Dana-Farber Cancer Institute and Brigham and Women’s Hospital, Boston, MA

3Beth Israel Deaconess Medical Center, Boston, MA

4Johns Hopkins Hospital, Baltimore, MD

5University of Washington, Seattle, WA

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R.R.M. and H.Y. contributed equally to this work.

doi.org/10.1200/JCO.18.01777

Abstract

PURPOSE

Patients with locally advanced prostate cancer have an increased risk of cancer recurrence and mortality. In this phase II trial, we evaluate neoadjuvant enzalutamide and leuprolide (EL) with or without abiraterone and prednisone (ELAP) before radical prostatectomy (RP) in men with locally advanced prostate cancer.

PATIENTS AND METHODS

Eligible patients had a biopsy Gleason score of 4 + 3 = 7 or greater, prostate-specific antigen (PSA) greater than 20 ng/mL, or T3 disease (by prostate magnetic resonance imaging). Lymph nodes were required to be smaller than 20 mm. Patients were randomly assigned 2:1 to ELAP or EL for 24 weeks followed by RP. All specimens underwent central pathology review. The primary end point was pathologic complete response or minimal residual disease (residual tumor ≤ 5 mm). Secondary end points were PSA, surgical staging, positive margins, and safety. Biomarkers associated with pathologic outcomes were explored.

RESULTS

Seventy-five patients were enrolled at four centers. Most patients had high-risk disease by National Comprehensive Cancer Network criteria (n = 65; 87%). The pathologic complete response or minimal residual disease rate was 30% (n = 15 of 50) in ELAP-treated patients and 16% (n = four of 25) in EL-treated patients (two-sided P = .263). Rates of ypT3 disease, positive margins, and positive lymph nodes were similar between arms. Treatment was well-tolerated. Residual tumors in the two arms showed comparable levels of ERG, PTEN, androgen receptor PSA, and glucocorticoid receptor expression. Tumor ERG positivity and PTEN loss were associated with more extensive residual tumors at RP.

CONCLUSION

Neoadjuvant hormone therapy followed by RP in locally advanced prostate cancer resulted in favorable pathologic responses in some patients, with a trend toward improved pathologic outcomes with ELAP. Longer follow-up is necessary to evaluate the impact of therapy on recurrence rates. The potential association of ERG and PTEN alterations with worse outcomes warrants additional investigation.

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NPfisherman profile image
NPfisherman

I participated in a study for apalutamide and Lupron prior to prostatectomy--30 days only---perhaps if it had been for a longer time prior or after, then I might not be in this situation...at this point, it doesn't matter....perhaps, it limited the cancer to a solitary tumor on my clavicle...only God knows...

Don Pedscado

tkalaf profile image
tkalaf

I underwent intense ADT and HT for 3 months last Spring, followed up with a RP. The clinical-trial I'm in is a study on Apalutamide's effectiveness, when combined with several other hard-hitting cancer medicines. You may read more in my postings.

In brief, at time of biopsy I was Dx'd as T2d and locally advanced G9. After my RP my pathological results revealed I was actually at T3a. Interestingly, my pathology also reported a reduction in PCa from 0.7 to 0.07 (or ~90%). With all Best of Health!

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