A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Goserelin.

It had two arms (groups): Arm 1 (experimental) and Arm 2 (experimental).

Metastatic hormone-sensitive prostate cancer (mHSPC):After diagnosis of mHSPC, patients receive infusions of autologous Tcm cells intravenously on Day 1 and Day 42, followed by hormonal therapy of maximal androgen blockade (LHRH-a + Anti-androgen).

The registry classes the interventions as biological.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to men only aged from 18 years up to 90 years.

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

Examples of who could join: Subjects who understand and sign the consent form for this study. Males age ≥18 years. Subjects diagnosed with metastatic hormone-sensitive prostate cancers (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC). Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Expected survival time of at least 24 months.

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: HIV infection; acute exacerbation of chronic hepatitis a or hepatitis b infection; the subject has a history of allogeneic organ transplants.

How the Study Was Run

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

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 2018-09-23 with completion listed for 2021-07-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidences of adverse events or serious adverse events (AE and SAE) (time frame: 2 years).

It also tracked 3 secondary outcomes, for example Time to castration-resistance (TCR) in mHSPC patients, Overall survival (OS) and Progression-free survival (PFS).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of Goserelin in 11 people.

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

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

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