Study of Histrelin Subdermal Implant in Patients With Prostate Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Goserelin.

This trial was an open-label, multi-national, randomized, parallel treatment, active-control multicenter study in adult males with documented metastatic prostate cancer disease who were judged to be candidates for hormone therapy.

It had two arms (groups): Zoladex goserelin implant. (active comparator) and Histrelin Acetate implant (experimental).

Zoladex goserelin implant: D, L-lactic and glycolic acids copolymer. Injected subcutaneously into the upper abdominal wall.

The registry classes the interventions as drug.

More on the Plan

This trial was an open-label, randomized, parallel treatment, active-control multicenter study in adult males with documented metastatic prostate cancer disease who were judged to be candidates for hormone therapy.

Written informed consent was obtained before any procedures were undertaken.

Once inclusion/exclusion criteria were met, baseline evaluations (physical assessment and examination, vital signs and weight, clinical laboratory evaluations, concomitant medications and procedures, adverse events, and a Quality of Life questionnaire) were obtained prior to implant insertion on Day 1 \[Visit 1\].

Patients with implants were evaluated at Week 1 and 2 \[Visits 2 and 3\] post-insertion for testosterone and PSA concentrations, vital signs, adverse events, and concomitant medications and procedures.

Who Took Part

Enrollment: 59 actual participants took part.

It was open to men only aged from 45 years with no upper age limit.

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

Examples of who could join: Male patients with histologically confirmed adenocarcinoma of the prostate. Clinically indicated for androgen suppression therapy. Age 45 years or older.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: bilateral orchiectomy; prior androgen-ablative or systemic corticosteroid therapy within the past year; second malignancy within five years, except adequately treated nonmelanomatous skin cancer or superficial bladder cancer.

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 Goserelin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2000-05 with completion listed for 2001-12.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Suppression of testosterone via the percent of patients whose testosterone was at or below chemical castration levels (<=50 n/dL) through 52 weeks of treatment (time frame: 52 weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 59 people.

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

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