Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients

What Was Tested

In this phase 4 trial, researchers set out to test Leuprolide and Goserelin.

It had two arms (groups): Intermittent Androgen Deprivation (experimental) and Continuous Androgen Deprivation (active comparator).

ADT including luteinizing hormone-releasing hormone (LHRH) agonist and antagonist, antiandrogen, or maximum androgen blockade (MAB) should be withdrawn after 6 months of ADT, if the prostate-specific antigen (PSA) reaches its nadir (\< 4 ng/dL) and serum testosterone reaches castration level (\< 50 ng/dL).

ADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.

The registry classes the interventions as drug.

More on the Plan

Objective: To determine the rate of bone mass loss induced by two therapeutic strategies of ADT (CAD versus IAD) in men with prostate cancer.

Design, setting, and participants: the investigators will perform randomized, open label clinical trial.

Men aged over 50 yrs old with prostate cancer (localized, locally advanced, metastatic prostate cancer) who are treated with primary ADT for newly diagnosed prostate cancer or salvage ADT at biochemical recurrence following radical prostatectomy will be included.

Participants will be randomly assigned to one of the following treatment arms: Arm 1 (CAD): ADT without any discontinuation during study period (12 months).

Who Took Part

164 planned participants were the target.

It was open to men only aged from 50 years with no upper age limit.

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

The full record lists 0 inclusion and 8 exclusion criteria; among the exclusions: men with double primary malignancies,; men who have been treated with adt or other drug therapy such as denosumab, bisphosphonate or steroid,; men with osteoporosis at baseline (t-score ≤ -2.5),.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2020-01-23 with completion listed for 2022-04-30.

It ran at 10 sites in South Korea (10).

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Change of L-spine total BMD (time frame: At baseline and 12 months).

It also tracked 4 secondary outcomes, for example Change of femur neck BMD, Osteoporosis, Risk of 10 year major osteoporotic fracture and Quality of life after treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide and Goserelin in 164 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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