Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy

What Was Tested

This registered phase 3 trial tested Leuprolide.

The overall aim of this project is to test the hypothesis that the addition of ADT to metastasis-directed radiotherapy (MDRT) in well-selected PCa patients with oligo-metastatic disease prolongs the metastases progression-free survival (MPFS) compared to MDRT alone.

It had two arms (groups): Radiotherapy without hormonal therapy (active comparator) and Radiotherapy combined with hormonal therapy (experimental).

Metastase-directed radiotherapy without the addition of hormonal therapy.

Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months).

The registry classes the interventions as drug and radiation.

Who Took Part

280 planned participants were the target.

It was open to men only 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: Histologically proven initial diagnosis of adenocarcinoma of the Prostate. Minimal 1 lesion and maximum 4 lesions (bone + lymph nodes) in total, without evidence of visceral metastases. Nodal relapse (N1) in the pelvis on PSMA-PET/CT with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation. Nodal relapse (M1a) on PSMA-PET/CT above the aortic bifurcation with a maximum of 3 positive lymph nodes. Bone relapse on PSMA-PET/CT with a maximum of 3 lesions.

The full record lists 13 inclusion and 8 exclusion criteria; among the exclusions: visceral metastases; PSA ≥ 10 ng/ml; PSA-doubling time ≤ 3 months.

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.

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

It started in 2020-03-19 with completion listed for 2027-10-21.

It ran at 13 sites in Netherlands (13).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Metastases progression-free survival (MPFS) (time frame: 2.5 years after treatment).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 280 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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