Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Leuprolide and Goserelin.

It had two arms (groups): DCVAC/PCA added Standard Hormone Therapy (experimental) and Standard of Care Hormone Therapy (active comparator).

Combination therapy with Dendritic Cells DCVAC/PCa added on to a Standard of Care Hormone Therapy.

Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate.

The registry classes the interventions as biological and drug.

Who Took Part

63 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: Male 18 years and older. Histologically confirmed prostate adenocarcinoma. Presence of bone or soft tissue metastasis (by CT or PET or MRI and/or scintigraphy). Eastern Cooperative Oncology Group (ECOG) 0-2.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: confirmed brain and/or leptomeningeal metastases; prior or ongoing chemotherapy for prostate cancer; peripheral neuropathy of common toxicity criteria (ctc) grade 2 or greater.

How the Study Was Run

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

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

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

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

It started in 2012-03 with completion listed for 2015-12.

It ran at 9 sites in Czechia (9).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Proportion of patients with PSA Progression (time frame: 104 weeks).

It also tracked 5 secondary outcomes, for example Proportion of patients with Progression of Disease, Frequency of Adverse Events, Frequency of Skeletal Related Events, Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30 and Changes in Pain assessed by EORTC QLQ-C30.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide and Goserelin in 63 people.

The trial is marked completed; 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.