Prostate radiotherapyEvaluating the relationship between erectile dysfunction and dose received by the penile bulb: Using data from a randomised controlled trial of conformal radiotherapy in prostate cancer (MRC RT01, ISRCTN47772397)
Section snippets
Trial and trial treatment
The MRC RT01 trial was a phase III open-treatment multi-centre randomised controlled trial of CFRT dose with an initial cohort study of neo-adjuvant androgen deprivation prior to randomisation. The RT01 trial was coordinated from the MRC Clinical Trials Unit (CTU), London, UK. The trial followed the principles of the Declaration of Helsinki. Ethical approval was attained by each centre and all men gave informed consent prior to registration. Prior to participation each centre had to ensure that
Results
From 843 patients randomised to RT01, 51 (6%) patients met the criteria for this sub-study (Fig. 1). Table 2 summarises the patient baseline demographic, clinical and treatment related parameters between the three groups. The median age for the whole cohort was 66 yr. Although clinical stage was fairly well balanced between the groups, those that became impotent were, perhaps, a little older (Potent 65 yr, Intermediate 66 yr and Impotent 70 yr). However there was no statistical difference observed
Discussion
This study demonstrates evidence of a dose–volume effect for radiation dose to the penile bulb (PB) and the presence at 2-years of erectile dysfunction (ED) in those receiving CFRT for localised PCa. The study focused on a tightly defined group of 51 men who were all potent before neo-adjuvant hormones were initiated and whose testosterone values had recovered by the 2-year assessment.
There are two principle reasons for such a low yield of patients from the cohort. Firstly 284 of the 843
Conclusions
Our study confirms that a dose–volume relationship exists between the PB and ED. It is possible to escalate the dose to the prostate without irradiating the PB to high dose. A D90 ⩾ 50 Gy is associated with a significant risk of ED, whilst the threshold for preservation of potency lies between 40 and 50 Gy. We advocate that the PB should be incorporated into CFRT plans for PCa as an avoidance structure and recommend excluding it from the high dose area.
We hope to incorporate the findings from this
Acknowledgments
This work was undertaken in The Royal Marsden NHS Foundation Trust who received a proportion of its funding from the NHS Executive; the views expressed in this publication are those by the authors and not necessarily those of the NHS Executive. This work was supported by the Institute of Cancer Research, the Bob Champion Cancer Trust and Cancer Research UK Section of Radiotherapy [CUK] grant number C46/A2131.
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