CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer

What Was Tested

This registered phase 1, phase 2 trial tested Leuprolide.

This is a multi-center, open label, randomized study.

Patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: Arm A: CP-675,206 + neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy.

After randomization, patients will receive study treatment for three cycles (one cycle is defined as 28 days).

The registry classes the interventions as drug.

Who Took Part

The registry lists 8 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologically confirmed adenocarcinoma of the prostate, previously untreated. Potential candidate for radical prostatectomy on the basis of the patient's general medical condition, performance status, and life expectancy. No evidence of metastatic disease by physical examination, bone scan, and computed tomography, or MRI, of the abdomen and pelvis. Age \> 18 years. ECOG performance status 0-1.

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: prior hormone therapy, radiation, chemotherapy, or immunologic therapy for prostate cancer; potential requirement for systemic corticosteroids before surgery based on prior history; any serious uncontrolled medical disorder or active infection which would impair ability to receive study treatment and subsequent prostatectomy.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

The Leuprolide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2004-03 with completion listed for 2006-03.

It ran at 11 sites in United States (11).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Leuprolide in 8 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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