Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

What Was Tested

This registered phase 2 trial tested Leuprolide and Goserelin.

It had two arms (groups): Arm A (antihormone therapy) (experimental) and Arm B (no antihormone therapy) (no intervention).

Patients receive leuprolide acetate IM on day 1 OR goserelin acetate SC on day 1. Courses repeat every 3 months for 9 months in the absence of disease progression or unacceptable toxicity.

Patients undergo observation every 3 months for 9 months.

The registry classes the interventions as drug and other.

More on the Plan

To explore if serum and urine biomarker(s) levels at study entry, 9 months, or 24 months in the two treatment arms are correlated with biochemical progression-free survival rate.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.

Courses repeat every 3 months for 9 months in the absence of disease progression or unacceptable toxicity.

Who Took Part

The registry lists 16 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: Informed consent explained and signed prior to any study related procedures. Patients with any one of the following "high risk" criteria:. Prostate-specific antigen (PSA) \> 20 ng/ml at initial presentation prior to radical prostatectomy. Willingness to provide mandatory tissue for research purposes. Willingness to provide mandatory blood for research purposes.

The full record lists 21 inclusion and 14 exclusion criteria; among the exclusions: history of bilateral orchiectomy; unilateral orchiectomy with normal range serum testosterone levels will be allowed for enrollment; receiving other experimental drugs =\< 4 weeks prior to consenting; uncontrolled infection.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

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

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2009-07 with completion listed for 2012-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Biochemical Progression-free Survival Rate (time frame: 2 years).

It also tracked 4 secondary outcomes, for example Percentage of Participants With Grade 3 or Higher Adverse Events Regardless of Attribution, Average Overall FACT-P Total Score at Baseline, Months 3 and 6 and Average LASA Overall Quality of Life at Baseline, Months 3 and 6.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide and Goserelin in 16 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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