Department of Radiation Oncology, Odette Cancer Centre, University of Toronto, Canada.
BJU Int. 2011 Oct;108(8 Pt 2):E164-70. doi: 10.1111/j.1464-410X.2010.10061.x. Epub 2011 Mar 24.
•To evaluate the effects of dutasteride on treatment-naïve prostate cancer in men using serial magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) in this pilot study.
•This investigator-initiated prospective single-arm study was approved by the institutional committee on human research ethics board. •The target accrual was 10 patients. Newly diagnosed prostate cancer patients with low risk disease either with symptomatic benign prostatic hypertrophy or deemed to require pre-brachytherapy androgen suppression therapy were eligible. In the latter group, dutasteride was used to achieve cytoreduction. •All patients received 6 months of dutasteride 3.5 mg daily and underwent baseline blood work, health-related quality of life indices and MRI/MRSI, which were repeated at 1, 3 and 6 months. •MRSI spectra were examined and scored as healthy or cancerous. The change in cancerous volumes over time was evaluated.
•Of the 10 patients enrolled, nine patients completed the entire study. One patient withdrew after 3 months because of drug-related toxicity. •Because a significant decrease in citrate and polyamines on MRSI spectra was noted at 1 month compared with baseline, healthy tissue appeared to be more like cancer and thus created a false impression that the cancer had grown after 1 month. To reduce this bias, comparisons were made between the 1-month and 6-month scans. •The median MR cancer volumes at 6 months and 3 months were 100% and 101% of the 1-month value, respectively. Three of the nine patients had a 30-45% decrease in cancer volume at 6 months relative to 1-month measures. Of the others, two had no change in cancer volume and four had an increase (range 65-167% of the 1-month value). •The median cancer volume (range) at baseline was only 0.5 (0.1-5.6) mL.
•The inclusion of only men with low volume disease may have limited our ability to accurately assess response rates after dutasteride due to the background effects on normal prostate metabolism. Despite this, one-third of patients had a 30-45% reduction in cancer volume at 6 months. •Future studies including men with larger volume disease may enable estimates of response rates to be made more accurately.
•在这项初步研究中，通过连续磁共振成像（MRI）和磁共振波谱成像（MRSI）评估 dutasteride 对未经治疗的前列腺癌患者的治疗效果。
•这项由研究人员发起的前瞻性单臂研究得到了机构人类研究伦理委员会的批准。•目标入组人数为 10 名患者。患有低危疾病的新发前列腺癌患者，伴有有症状的良性前列腺增生或被认为需要近距离放射治疗前的雄激素抑制治疗，符合入组条件。在后一组中，使用 dutasteride 进行细胞减少。•所有患者均接受 dutasteride 3.5 mg 每日一次治疗 6 个月，并在基线时进行血液检查、健康相关生活质量指数和 MRI/MRSI，在 1、3 和 6 个月时重复检查。•检查 MRSI 光谱并评分，判断为健康或癌症。评估随时间推移的癌体积变化。
•10 名入组患者中，9 名患者完成了整个研究。1 名患者因药物相关毒性在 3 个月后退出。•由于与基线相比，在 1 个月时 MRSI 谱上的柠檬酸和多胺显著减少，因此健康组织似乎更像癌症，从而造成一种假象，即在 1 个月后癌症已经生长。为了减少这种偏差，对 1 个月和 6 个月的扫描结果进行了比较。•6 个月时的中位 MR 癌体积和 3 个月时的中位 MR 癌体积分别为 1 个月时的 100%和 101%。9 名患者中有 3 名患者在 6 个月时的癌体积与 1 个月时相比下降了 30-45%。其他患者中，2 名患者的癌体积无变化，4 名患者的癌体积增加（范围为 1 个月时的 65-167%）。•基线时的中位癌体积（范围）仅为 0.5（0.1-5.6）mL。
•由于 dutasteride 对正常前列腺代谢的背景影响，仅纳入低体积疾病的男性可能限制了我们准确评估 dutasteride 治疗后反应率的能力。尽管如此，仍有三分之一的患者在 6 个月时的癌体积减少了 30-45%。•包括更大体积疾病的男性的未来研究可能能够更准确地估计反应率。
