We know that the incidence of both cardiovascular disease (CVD) and prostate cancer increase with age, resulting in higher mortality. CVD is the second most common cause of death in men with prostate cancer [1,2] Hormone therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists like Lupron for treatment of prostate cancer has been linked to additional increases in CVD morbidity and mortality. This link is especially evident in the first year of treatment [3], and men with a history of CVD are at higher risk [3].
Degarelix, which is different from the (GnRH) agonists, is a GnRH receptor antagonist also approved for the treatment of men with advanced prostate cancer. However, good data is suggesting that degarelix might have a lower incidence of causing CVD than the GnRH agonists in men with pre-existing CVD. This lower risk may be due to its different mode of action, leading to lower levels of atherosclerotic plaque and plaque instability [4], both of which can lead to CV events.
In the PRONOUNCE study, the primary objective is to assess the effect of degarelix (Firmagon) vs. the GnRH agonist leuprolide (Lupron) on the risk of experiencing a recurrence for a major adverse cardiovascular event in men with prostate cancer and concomitant cardiovascular disease (CVD). Additional objectives of the trial included prostate cancer outcomes, other cardiovascular (CV) outcomes, patient-reported outcomes (PROs), and overall safety and tolerability.
RESULTS
Preliminary trial data show that hormone therapy (ADT) may increase the incidence of CV events in men with prostate cancer who also had pre-existing CVD. The data also showed that the prevalence of CV might be lower with degarelix than the GnRH agonists.
This trial is still on-going and continuing to recruit.
Clinical Trial Information: NCTO2663908
References:
1. Studer UE et al. JCO 2006;24:1868-76
2. Calais da Silva FE et al. Eur Urol 2009;55:1269-77
3. O’Farrell et al. JCO 2015l 33:1243-51
4. Crawford ED et al. J UROL 2011; 186:889-97
By Joel T Nowak
