EORTC prostate cancer trials: what have we learnt?

Abstract 

The aims of the European Organization for Research and Treatment of Cancer-GU (EORTC-GU) Group are to improve the treatment of cancer related problems by carrying out multicenter, multinational and intercontinental Phases II and III trials and the dissemination of their results via workshops, congresses and symposia. The first studies in prostate cancer dealt with the use of chemotherapeutic agents in advanced tumours. Mitomycin C was the most active agent identified. We have learnt that the primary tumour should not be used for response assessment in advanced disease but that Quality of life (QoL) assessment consistently applied may be. In later studies QoL and PSA response were considered as the most important endpoints for Phase II trials in this disease. In patients with locally advanced or metastatic disease maximal androgen blockade (MAB), in different forms, has been studied. Conflicting outcomes have been observed, which could be explained by the inclusion of patients with different prognostic factors at entry in the studies. The anti-androgen monotherapy approach in patients with M+ disease with good prognostic factors has been shown to be feasible, side effects using a steroidal agent were higher compared with non-steroidal agents. The hormono-chemotherapy approach in patients with M+ disease and poor prognostic factors at entry showed not to be of any benefit in terms of survival and also QoL was worse in these patients. Patients with locally advanced disease treated with external beam radiation therapy had a significant better survival if this treatment was combined with 3 years of hormonal therapy. The ongoing Phase III study in metastatic prostate cancer is comparing intermittent hormonal therapy and continuous treatment and in locally advanced prostate cancer a Phase III trial is testing the so-called step-up and step-down regimen.

Keywords:  Prostate cancer, Trials, Phase II, Phase III, EORTC-GU Group