IMAAGEN - Abiraterone Acetate & Prednisone in non-mCRPC.

[pjoshea13]

New - IMAAGEN study results below [1]. Trial details: [2].

"To evaluate the use of abiraterone acetate (1000 mg) plus prednisone (5mg) [AA+P] in patients with high-risk non-metastatic castration resistant prostate cancer (nmCRPC)."

"PSA was significantly reduced .., with 86.9% {50% PSA reduction} and 59.8% {90% PSA reduction}."

"Median time to PSA progression was 28.7 months"

"Median time to radiographic evidence of disease progression was not reached but was estimated to be 41.4 months"

"Baseline testosterone ≥12.5 ng/dL and PSA90 at cycle 3 were associated with longer times to PSA progression and radiographic evidence of disease progression."

-Patrick

ncbi.nlm.nih.gov/pubmed/296...

J Urol. 2018 Apr 6. pii: S0022-5347(18)42900-X. doi: 10.1016/j.juro.2018.03.125. [Epub ahead of print]

The IMAAGEN Study: Effect of Abiraterone Acetate and Prednisone on Prostate-Specific Antigen and Radiographic Disease Progression in Patients with Non-Metastatic Castration-Resistant Prostate Cancer.

Ryan CJ1, Crawford ED2, Shore ND3, Underwood W 3rd4, Taplin ME5, Londhe A6, St John Francis P7, Phillips J8, McGowan T9, Kantoff PW10.

Author information

1

Helen Diller Family Comprehensive Cancer Center, University of California-San Francisco, San Francisco, CA. Electronic address: [e-mail].

2

University of Colorado Cancer Center, Aurora, CO. Electronic address: [e-mail].

3

Carolina Urologic Research Center, Myrtle Beach, SC. Electronic address: [e-mail].

4

Roswell Park Cancer Institute, Buffalo, NY. Electronic address: [e-mail].

5

Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA. Electronic address: [e-mail].

6

Janssen Scientific Affairs, LLC, Horsham, PA. Electronic address: [e-mail].

7

Janssen Scientific Affairs, LLC, Horsham, PA. Electronic address: [e-mail].

8

Janssen Scientific Affairs, LLC, Horsham, PA. Electronic address: [e-mail].

9

Janssen Scientific Affairs, LLC, Horsham, PA. Electronic address: [e-mail].

10

Memorial Sloan Kettering Cancer Center, New York, N.Y. Electronic address: [e-mail].

Abstract

PURPOSE:

To evaluate the use of abiraterone acetate (1000 mg) plus prednisone (5mg) [AA+P] in patients with high-risk non-metastatic castration resistant prostate cancer (nmCRPC).

MATERIALS AND METHODS:

Patients considered at high risk for progression to metastatic disease (PSA≥10 ng/mL or PSADT≤10 months) received AA+P daily (28-day cycles). The primary endpoint was the proportion of patients achieving PSA50 during cycles 1-6. Secondary endpoints included time to PSA progression, time to radiographic evidence of disease progression, and safety.

RESULTS:

Of 131 enrolled patients, 44 (34%) remain on treatment, with a median follow-up of 40.0 months. Median age was 72 (48-90) years. Most patients (82.4%) were white; 14.5% were black. Median screening PSA was 11.9 ng/dL and PSADT was 3.4 months. PSA was significantly reduced (p<0.0001), with 86.9% PSA50 and 59.8% PSA90. Median time to PSA progression was 28.7 months (95% CI 21.2, 38.2). Median time to radiographic evidence of disease progression was not reached but was estimated to be 41.4 months (95% CI 27.6, NE) by sensitivity analysis with 15 patients. Baseline testosterone ≥12.5 ng/dL and PSA90 at cycle 3 were associated with longer times to PSA progression and radiographic evidence of disease progression. Outcomes for black patients were similar to other patients. Adverse events, Grade ≥3 AEs, and SAEs were reported in 96.2%, 61.1%, and 43.5% of patients respectively.

CONCLUSIONS:

In patients with high-risk nmCRPC, treatment with AA+P demonstrated a significant reduction in PSA50 with encouraging results for the secondary endpoints including the safety of 5 mg P.

Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

KEYWORDS:

abiraterone acetate; prostatic neoplasms

PMID: 29630978 DOI: 10.1016/j.juro.2018.03.125

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[2] clinicaltrials.gov/ct2/show...

[smroush]

The percentages for serious side effects seem very high, especially for such commonly prescribed medications.