VITAMIN D TREATMENT OF PROSTATE CANCER

流行病学数据表明，维生素D可能在前列腺癌的发病机制中发挥作用。此外，体外和动物研究表明，维生素D可以抑制前列腺癌细胞的生长。这项研究旨在研究维生素D在治疗早期前列腺癌男性患者中的潜在临床效用。如果男性在前列腺癌的初级治疗(前列腺癌手术或放射治疗)后，其血清前列腺癌标记物前列腺特异性抗原(PSA)水平升高，就可以参加这项研究。他们必须有A或B期疾病，没有转移的证据，因此有最小的复发疾病。这项研究的主要目的是显示在接受维生素D治疗(骨化三醇，Rocaltrol-Roche)时，PSA水平的上升速度放缓，作为前列腺癌生长放缓的一个指标。到目前为止，已有8名其他方面健康的男性参加了这项研究。一名受试者在开始治疗前因发现潜在的转移性疾病而被排除在外。已有7名受试者开始接受骨化三醇治疗。由于肾结石的发展，两名受试者退出了治疗。其中一名受试者退出了研究，因为他的医生启动了雄激素消融治疗，尽管没有客观证据表明这名受试者的癌症进展。所有7名受试者都对治疗表现出了有益的反应，与开始治疗前相比，PSA的上升速度有所放缓。减速在每个案例中都是显著的，对整个群体来说也是如此。每个受试者的基线PSA倍增时间不同，对骨化三醇的反应至少是倍增时间的两倍。在一些患者中，加倍时间增加了五倍。虽然招募工作已经结束，但仍有2名男性患者的研究仍在进行中，这是因为PSA上升速度放缓所显示的对治疗的有益反应。

Epidemiologic data suggest that vitamin D may play a role in the pathogenesis of prostate cancer. Moreover, in vitro and animal studies have shown that vitamin D inhibits the growth of prostate cancer cells. This study was designed to examine the potential clinical utility of vitamin D in treating men with early stages of prostate cancer. Men were enrolled into this study if, after primary treatment of their prostate cancer (surgical prostatectomy or radiation therapy), they demonstrated a rising serum level of the prostate tumor marker, Prostatic Specific Antigen (PSA). They must have had stage A or B disease and not have evidence of metastasis, and therefore have minimal recurrent disease. The primary endpoint of the study is to show a slowing of the rate of rise of PSA levels as an index of slowed prostate cancer growth while on vitamin D therapy (calcitriol, Rocaltrol-Roche). Eight otherwise healthy men have thus far been enrolled in this study. One subject was excluded prior to the initiation of therapy due to the identification of potential metastatic disease. Seven subjects have been initiated on calcitriol therapy. Two subjects were withdrawn from therapy due to the development of kidney stones. One subject was withdrawn from the study because his physician initiated androgen ablation therapy, although there was no objective evidence of cancer progression in this individual. All 7 subjects have shown a beneficial response to the therapy, with a slowing of the PSA rate of rise compared to the rate of rise before therapy was initiated. The slowing was significant in every case as well as the group as a whole. The baseline PSA doubling time in each subject differed, the response to calcitriol was at least a doubling of the doubling time. In some patients the doubling time increased five-fold. Although recruitment has closed, study is ongoing in 2 men because of the beneficial response to therapy as indicated by slowed rate of PSA rise.