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LHRH sparing therapy in patients with chemotherapy-naive, mCRPC treated with abiraterone acetate plus prednisone: results of the randomized phase II SPARE trial.

ABSTRACT:

Background

Although the benefit of androgen deprivation therapy (ADT) continuation in metastatic castration-resistant prostate cancer (mCRPC) remains controversial, clinical evidence is lacking. Recent results indicated that treatment with abiraterone acetate (AA) plus prednisone (P) further suppresses serum testosterone levels over ADT alone, suggesting that continuation of ADT in the treatment of mCRPC may not be necessary.

Methods

In this exploratory phase 2 study, mCRPC patients were randomized with a 1:1 ratio to receive either continued ADT plus AA + P (Arm A) or AA + P alone (Arm B). The primary endpoint was the rate of radiographic progression-free survival (rPFS) at month 12. Secondary endpoints included PSA-response rate, objective response, time to PSA progression and safety.

Results

A total of 68 patients were equally randomized between the two study arms. Median testosterone-levels remained below castrate-levels throughout treatment in all patients. According to the intention-to-treat analysis the rPFS rate was 0.84 in Arm A and 0.89 in Arm B. Moderate and severe treatment-emergent adverse events were reported for 72% of the patients in Arm A and for 85% of the patients in Arm B.

Conclusions

AA + P treatment without ADT may be effective in mCRPC patients and ADT may not be necessary in patients receiving AA + P.

SUBMITTER: Ohlmann CH

PROVIDER: S-EPMC9705242 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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LHRH sparing therapy in patients with chemotherapy-naïve, mCRPC treated with abiraterone acetate plus prednisone: results of the randomized phase II SPARE trial.

Ohlmann Carsten-Henning CH Jäschke Michelle M Jaehnig Peter P Krege Susanne S Gschwend Jürgen J Rexer Heidrun H Junker Kerstin K Zillmann Roger R Rüssel Christoph C Hellmis Eva E Suttmann Henrik H Janssen Martin M Marin Jan J Hübner Andreas A Mathers Michael M Gleißner Jochen J Scheffler Michael M Feyerabend Susan S Telle Jens J Klier Jörg J Stöckle Michael M

Prostate cancer and prostatic diseases 20220416 4

<h4>Background</h4>Although the benefit of androgen deprivation therapy (ADT) continuation in metastatic castration-resistant prostate cancer (mCRPC) remains controversial, clinical evidence is lacking. Recent results indicated that treatment with abiraterone acetate (AA) plus prednisone (P) further suppresses serum testosterone levels over ADT alone, suggesting that continuation of ADT in the treatment of mCRPC may not be necessary.<h4>Methods</h4>In this exploratory phase 2 study, mCRPC patien ...[more]

PMID: 35430584

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