Post-operative or Early Salvage XRT and ADT for High Risk PCa

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide.

RATIONALE: Conformal radiation therapy uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor.

It had two arms (groups): Arm I (active comparator) and Arm II (experimental).

Patients undergo post-operative conformal external beam irradiation for 6.5 weeks.

Beginning on day -5 to -3, patients receive an antiandrogen for 2-4 weeks. Beginning on day 0, patients receive leuprolide acetate subcutaneously once (6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5 weeks.

The registry classes the interventions as drug and radiation.

More on the Plan

OUTLINE: This is a multicenter study.

Patients are stratified according to institution, pathological stage (pT2R1 vs pT3R0 vs pT3R1), Gleason sum (≤ 3+4 vs ≥ 4+3), and WHO performance status (0 vs 1).

Beginning on day 0, patients receive leuprolide acetate subcutaneously once (6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5 weeks.

Patients undergo quality of life assessments periodically.

Who Took Part

The registry lists 87 actual participants took part.

It was open to men only aged up to 80 years.

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

Examples of who could join: Clinical stage cT1-2-3a, N0, M0 disease pre-operatively. Pre-operative PSA ≤ 5 x upper limit of normal. Presenting the following conditions after radical prostatectomy:. Gleason sum 5-10. Pathologic stage pT2R1 (positive surgical margins with at least a tumor trans-section \> 2 mm) or pT3a-b (irrespective of margin status).

The full record lists 21 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2009-10 with completion listed for 2015-12.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Biochemical progression-free survival.

It also tracked 5 secondary outcomes, for example Clinical progression-free survival, Distant-metastases-free survival, Overall survival and Acute and late toxicity according to NCI CTCAE version 3.0.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 87 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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