Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer

What Was Tested

The trial (phase 2) is built around Leuprolide.

The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response.

This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.

It had two arms (groups): Arm 1: Sipuleucel-T followed by ADT (experimental) and Arm 2: ADT followed by sipuleucel-T (experimental).

The registry classes the interventions as biological and drug.

More on the Plan

Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions.

An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.

An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.

Safety assessments included adverse event (AE) monitoring, laboratory tests (complete blood count (CBC) and serum chemistry), vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, as well PSA and testosterone monitoring.

Who Took Part

Enrollment: 68 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: Hormone-sensitive prostate cancer. Non-metastatic disease, as evidenced by negative bone scan or computed tomography of the abdomen and pelvis. ECOG performance status ≤ 1. Histologically documented prostate cancer. Prior primary therapy for prostate cancer.

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: requires systemic ongoing immunosuppressive therapy; history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-t or gm-csf; prior sipuleucel-t therapy.

How the Study Was Run

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

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2011-09 with completion listed for 2014-12.

It ran at 14 sites in United States (14).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024 (time frame: PA2024 ELISPOT counts at Month 24).

It also tracked 1 secondary outcome, for example Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 68 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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