Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624

What Was Tested

The trial (phase 3) is built around Leuprolide and Goserelin.

The optimal indication for ADT has long been a point of controversy, at least until the results of randomised trials comparing RT with and without ADT were published.

NCCN guidelines and most retrospective series and left the decision to prescribe ADT in combination with RT to the discretion of the treating physician, despite a lack of clear scientific evidence to support this recommendation.

It had two arms (groups): short-term ADT (6 months) (active comparator) and long-term ADT (24 months) (active comparator).

ARM 1: LHRH analogues for 6 months + bicalutamide 50 for 30 days.

LHRH analogues for 24 months + bicalutamide 50 for 30 days.

The registry classes the interventions as drug.

Who Took Part

534 planned participants were the target.

It was open to people of any sex 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: Patients with histologically-confirmed prostate cancer treated with radical prostatectomy. Patients who have not undergone lymph node dissection are eligible for inclusion. Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al. (18):. Testosterone level \> 150 ng/dL at inclusion. Life expectancy \> 5 years. Signed informed consent.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: presence of pn1 disease in the original surgical specimen; PSA \<0.2 or \<0.15 ng/mL (if Gleason score=10, pT3b, or R1 in the radical prostatectomy specimen); previous pelvic radiotherapy.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

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

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

It started in 2023-03-14 with completion listed for 2023-12.

It ran at 17 sites in Spain (17).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To compare 5-year MFS rates in prostate cancer patients treated with long- versus short-term ADT in combination with salvage radiotherapy (time frame: 5 years).

It also tracked 9 secondary outcomes, for example To compare the two study arms in terms of the Biochemical-relapse free interval, To compare the two study arms in terms of the Pelvic progression-free survival, To compare the two study arms in terms of the Time to start of cytotoxic treatment, To compare the two study arms in terms of the Time to castration resistance, To compare the two study arms in terms of the Cancer-specific survival and To compare the two study arms in terms of the Overall survival.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide and Goserelin in 534 people.

With 534 participants it is a large trial for this field.

It is still recruiting; 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.