A Neoadjuvant Study of Androgen Ablation Combined With Cyclophosphamide and GVAX Vaccine for Localized Prostate Cancer

What Was Tested

This registered phase 1, phase 2 trial tested Degarelix.

It had two arms (groups): Degarelix (active comparator) and Cyclophosphamide, GVAX and Degarelix (experimental).

The registry classes the interventions as drug.

More on the Plan

The release of granulocytemacrophage-colony stimulating factor by these modified tumor cells serves to recruit dendritic cells which then present tumor antigens to T-cells, thus initiating antitumor immune responses.

However, abundant preclinical data show that, when used alone, cell-based immunotherapy is unable to break specific T-cell tolerance in tumor-bearing hosts.

Who Took Part

29 actual participants took part.

It was open to men only aged from 21 years with no upper age limit.

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

Examples of who could join: Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs. Initial prostate biopsy is available for central pathologic review, and is confirmed to show at least 2 positive cores and a maximum Gleason sum of ≥ 7. Age ≥ 21 years. Adequate bone marrow, hepatic, and renal function:. White Blood Count \> 3,000 cells/mm3.

The full record lists 17 inclusion and 14 exclusion criteria; among the exclusions: presence of known lymph node involvement or distant metastases; previous or concurrent use of cyclophosphamide; current use of systemic corticosteroids or use of corticosteroids within 4 weeks of enrollment (inhaled corticosteroids for asthma or chronic obstructive pulmonary disease are permitted).

How the Study Was Run

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

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

The Degarelix group and the comparison group ran side by side rather than switching.

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

It started in 2013-01-18 with completion listed for 2017-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Intraprostatic CD8+ T Cell Infiltration (time frame: 2 years).

It also tracked 7 secondary outcomes, for example Intraprostatic CD4+ T Cell and Treg Infiltration, Quantification of Tissue Androgen Concentrations, Quantification of Markers of Apoptosis, Pathological Complete Responses, Serum Antibodies to Prostate-associated Antigens and Prostate-specific Antigen Response Rate.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Degarelix in 29 people.

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

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

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