Treatment of newly diagnosed state D2 prostate cancer with leuprolide and flutamide or leuprolide alone, phase III, intergroup study 0036

What Was Tested

Researchers studied Leuprolide in this randomized controlled trial publication.

In order to test the hypothesis of complete androgen blockade for advanced prostate cancer (D2CaP), an intergroup trial was instituted in 1985 comparing leuprolide (L) alone to the combination of L with flutamide (F).

Why It Was Studied

Eligibility requirements included previously untreated histologically confirmed stage D2CaP, measurable bone or soft tissue metastases, performance status (PS) of 3 or better, acceptable renal and hepatic function, no severe cardiac disease, and no prior or concomitant endocrine therapy.

Stratification at entry was on the basis of PS and none or minimal disease (MD) versus severe degree (SD) of bone metastases.

Who Took Part

According to the abstract, 107 patients were involved.

PubMed tags the participants as men only.

How the Study Was Run

The design is described as randomized.

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

What Was Measured

Eligibility requirements included previously untreated histologically confirmed stage D2CaP, measurable bone or soft tissue metastases, performance status (PS) of 3 or better, acceptable renal and hepatic function, no severe cardiac disease, and no prior or concomitant endocrine therapy.

Topics PubMed links to this paper include Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Bone Neoplasms, Drug Evaluation, Flutamide, Gonadotropin-Releasing Hormone and Hormones.

What This Means in Plain Language

The paper is a randomized study of Leuprolide in 107 patients.

The publication is from 1990 (The Journal of steroid biochemistry and molecular biology), a journal based in England.

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