Stage T3 prostate cancer: a nonrandomized comparison between definitive irradiation and induction hormonal manipulation plus prostatectomy.

What Was Tested

The paper reports a study of Leuprolide and Flutamide, published as a phase 2 clinical trial.

At their institution, a Phase II trial using androgen suppression followed by surgery was completed for men with Stage T3 disease and negative laparoscopic nodal dissection.

The researchers recently reported the unfavorable biochemical outcome of that experience.

Because that analysis did not include a control group of irradiated patients, the current project was undertaken to compare that Phase II experience with clinical Stage T3 patients treated at their institution with definitive irradiation during an overlapping period of time.

Who Took Part

The study group was 21 patients.

By PubMed's age tags, the people studied were middle-aged adults, older adults and people over 80, men only.

The Phase II trial included 21 patients with T3 tumors and negative laparoscopic nodal dissections treated by 4 months of neoadjuvant hormonal treatment (leuprolide +/- flutamide) prior to radical prostatectomy.

Patients who declined to participate in the study or those judged ineligible by virtue of poor surgical risk were treated with definitive irradiation (n = 29).

How the Study Was Run

Biochemical failure after prostatectomy was defined as prostate-specific antigen (PSA) levels exceeding 0.2 ng/mL.

Biochemical failure after irradiation was defined as a rise in absolute level of PSA greater than 1.5 ng/mL, or two consecutive elevations of PSA on sequential measurements, even if the absolute level was less than 1.5 ng/mL.

What Was Measured

PubMed files the paper under topics including Age Factors, Analysis of Variance, Androgen Antagonists, Antineoplastic Agents, Hormonal, Antineoplastic Combined Chemotherapy Protocols, Chemotherapy, Adjuvant and Disease-Free Survival.

What This Means in Plain Language

This is a phase 2 clinical trial of Leuprolide and Flutamide in 21 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 5 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 1998 (Urology), a journal based in United States.

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