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

What Was Tested

The paper reports a study of Leuprolide, published as a randomized controlled trial.

In this phase II trial, the researchers evaluate neoadjuvant enzalutamide and leuprolide (EL) with or without abiraterone and prednisone (ELAP) before radical prostatectomy (RP) in men with locally advanced prostate cancer.

Who Took Part

The age groups tagged for this paper are adults, middle-aged adults and older adults, men only.

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).

Patients were randomly assigned 2:1 to ELAP or EL for 24 weeks followed by RP.

How the Study Was Run

The researchers set it up as a randomized study.

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

The timeline in the abstract includes 24 weeks.

Lymph nodes were required to be smaller than 20 mm.

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.

What Was Measured

The subject headings attached to it are Adenocarcinoma, Androgen Antagonists, Androstenes, Antineoplastic Combined Chemotherapy Protocols, Benzamides, Chemotherapy, Adjuvant and Kallikreins.

What This Means in Plain Language

The paper is a randomized study of Leuprolide over 24 weeks.

Results are reported in around 9 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2019 (Journal of clinical oncology : official journal of the American Society of Clinical Oncology), a journal based in United States.

More context: the Leuprolide compound page, all human trials.