Androgen Suppression With Stereotactic Body or External Beam Radiation Therapy (ASSERT)

What Was Tested

The trial (not phased) is built around Goserelin.

Brachytherapy, in which radioactive seeds are inserted into the prostate, produces excellent outcomes but is invasive and not all patients are eligible or willing to receive this treatment.

EBRT, while gentle at the time of delivery, tends to be very prolonged and may have poorer outcomes than brachytherapy.

It had two arms (groups): SABR with androgen suppression (experimental) and EBRT with androgen suppression (active comparator).

The registry classes the interventions as drug and radiation.

More on the Plan

The two primary objectives of the study are to assess the feasibility of randomization, and to compare the rates of acute and late toxicities.

Should randomization prove feasible, and toxicities comparable, a future phase 3 trial will be pursued.

To determine the proportion of eligible patients who are willing to be randomized 2.

To compare the disease free survival as reflected in biochemical relapse free survival at five years between the two interventions 2.

Who Took Part

80 planned participants were the target.

It was open to men only.

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

Examples of who could join: High risk is defined by any of: ≥T3a, PSA \> 20, or Gleason ≥ 8. Intermediate risk is defined by: T1/T2 and/or Gleason ≤ 7 and/or PSA ≤20 and not low risk. Disease must be T1 or T2 clinically. History/physical examination with digital rectal examination of the prostate within 60 days of registration or commencement of androgen deprivation therapy. Life expectancy of at least 5 years.

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 2016-04 with completion listed for 2024-12.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of subjects experiencing treatment-related acute and late toxicities, focussing on grade 3 and 4 complications, as assessed by the NCI CTCAEv4 and modified RTOG/SOMA toxicity scale (time frame: 5 years).

It also tracked 3 secondary outcomes, for example Number of subjects with biochemical relapse free survival at five years as measured by PSA levels, To compare the health related quality of life as reflected in changes on the EPIC questionnaire between the two interventions and To measure the mean prostate pre-fraction to post-fraction displacement, in millimeters, from CT scans done pre- and post-fraction.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Goserelin in 80 people.

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.