Induction androgen deprivation plus prostatectomy for stage T3 disease: failure to achieve prostate-specific antigen-based freedom from disease status in a phase II trial.

What Was Tested

Researchers studied Leuprolide and Flutamide in this phase 2 clinical trial publication.

There is interest in treating prostate cancer with induction androgen deprivation prior to radical prostatectomy.

Data on long-term prostate-specific antigen (PSA)-based survival analyses among patients treated with neoadjuvant hormonal therapy (NHT) and prostatectomy are limited.

In 1991 the researchers instituted a pilot study for T3 disease based on endorectal coil magnetic resonance imaging (eMRI), mandatory negative laparoscopic nodal dissection prior to hormonal manipulation, and prostatectomy followed by pathologic and PSA-based outcome determinations.

Who Took Part

The abstract describes 26 patients taking part.

By PubMed's age tags, the people studied were middle-aged adults and older adults, men only.

Of 26 patients, 21 had negative laparoscopic lymphadenectomy followed by 4 months of NHT (leuprolide +/- flutamide) prior to radical prostatectomy. eMRI was performed at the time of diagnosis and following hormonal treatment.

Prostatectomy specimens were evaluated by 3-mm whole-mount step sections.

How the Study Was Run

In design terms this was a pilot study.

It is described as a pilot, a small early test of whether a larger Leuprolide study would be practical.

Serum PSA was determined at 3-month intervals.

What Was Measured

Topics PubMed links to this paper include Androgen Antagonists, Antineoplastic Agents, Hormonal, Combined Modality Therapy, Flutamide, Leuprolide, Neoplasm Staging and Preoperative Care.

What This Means in Plain Language

The paper is a pilot study of Leuprolide and Flutamide in 26 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 1996 (Urology), a journal based in United States.

More context: the related Leuprolide library page, all human trials.