Modelling relapse in patients with high-risk localised prostate cancer treated randomly in the GETUG 12 phase III trial reveals two populations of relapsing patients

Background

The patterns of relapse in patients with high-risk prostate cancer treated with modern therapy are poorly described. In the present study, we aimed to analyse the patterns of relapse in the randomized phase III trial Groupe d'Etude des Tumeurs Uro-Genitales 12 (GETUG 12) in patients with high-risk localised prostate cancer.

Methods

Patients were enrolled and randomly assigned to receive either androgen deprivation therapy (ADT) with goserelin every 3 months for 3 years combined upfront with 4 cycles of docetaxel and estramustine (ADT + DE) or ADT alone, plus local therapy. We analysed the pattern of second event-free-survival (PFS2) in patients with biochemical progression (bPFS). Adjusting factors were stratification factors (T stage, Gleason score, baseline PSA, and pN status) and treatment.

Results

413 patients were randomized from 2002 to 2006, 206 treated with ADT alone and 207 with ADT + DE. Median follow-up was 8.8 years (IQR: 8.1-9.7). A total of 130 patients exhibited biochemical relapse, with a median bPFS of 5 years (range: 0.23-10.4) for relapsing patients. 77/130 patients subsequently developed a second event: metastatic progression (53), clinical progression (13) and death (7). The analysis of relapsing patients revealed the following data: 1) the median time from biochemical failure to a clinical event was 2 years [95% CI: 1.07 – 2.91]; 2) biochemical relapses were rare (n = 27; 21%) within the first 3 years (

Conclusions

This analysis of the GETUG 12 trial demonstrates that overall, a clinical event is to be expected, with a median time of 2 years in patients with high-risk localised prostate cancer who develop a biochemical relapse, and that the timing of this relapse is highly prognostic with twice as many clinical events likely to occur in patients relapsing within the first 3 years.

Clinical trial identification

GETUG 12: ClinicalTrials.gov NCT00055731

Legal entity responsible for the study

Institut Gustave Roussy

Funding

N/A

Disclosure

A. Flechon: Sanofi. S. Oudard: Sanofi, Bayer, Astellas, Janssen. K. Fizazi: Participation to advisory boards and honorarium: Sanofi. All other authors have declared no conflicts of interest.