多西他赛联合泼尼松或米托蒽醌联合泼尼松治疗激素抵抗性前列腺癌

背景与目的：以多西他赛为核心的化疗方案已经成为激素抵抗性前列腺癌治疗的一线方案：本文初步比较多西他赛联合泼尼松或米托蒽醌联合泼尼松在雄激素抵抗性前列腺癌中的疗效差异，进一步探讨这两种方案的毒副反应。方法：入选雄激素抵抗性前列腺癌患者共83例，其中44例给予多西他赛75mg／m^2 d1静脉滴注联合泼尼松，5mg，每天2次，d1～21口服方案治疗（简称多西他赛组），39例给予米托蒽醌12mg／m^2 d1静脉滴注联合泼尼松，5mg，每天2次，d1～21口服方案治疗（简称米托蒽醌组）。两方案均以21天为1周期，平均治疗5周期：结果：多西他赛组中13．6％（6／44）完全缓解（治疗后PSA下降至4．0ng／ml以下），29．5％（13／44）部分缓解，29．5％（13／44）稳定，27．3％（12／44）进展。缓解和稳定患者的PSA进展中位时间是37．8周（12～101周）。进展的12例患者接受了后续的米托蒽醌组挽救治疗，结果部分缓解16．7％（2／12），稳定25．0％（3／12），2例患者死于疾病进展。米托蒽醌组中7．7％（3／39）完全缓解，25．6％（10／39）部分缓解，25．6％（10／39）稳定，41．0％（16／39）进展：缓解和稳定患者的PSA进展中位时间是25．3周（8～61周）。进展的14例患者接受了后续的多西他赛组方案的挽救治疗，结果完全缓解7．1％（1／14），部分缓解35．7％（5／14），稳定21．4％（3／14）．4例患者死于疾病进展：毒性评估：接受多西他赛组治疗者44例，Ⅲ～Ⅳ度骨髓抑制9例（2例因不能耐受化疗退出），Ⅱ度骨髓抑制14例；接受米托蒽醌组治疗者39例，Ⅲ～Ⅳ度骨髓抑制4例，Ⅱ度骨髓抑制12例。结论：多西他赛组或米托蒽醌组均是治疗雄激素抵抗性前列腺癌的有效化疗方案。两种方案对中国的前列腺癌患者的治疗效果比较接近，但米托蒽醌联合泼尼松的治疗方案的副作用略轻。两种方案交替使用仍可产生部分的反应率，两种方案可以互为挽救方案．且多西他赛联合泼尼松作为挽救方案疗效好于米托蒽醌联合泼尼松。     

多西他赛联合泼尼松治疗激素难治性前列腺癌的临床研究

[目的]探讨多西他赛联合泼尼松3周方案治疗激素难治性晚期前列腺癌的临床效果及毒副反应。[方法]12例激素难治性晚期前列腺癌患者接受治疗方案：多西他赛75mg/m^2,d1,静脉滴注;泼尼松5mg,2次／d,d1-21口服;每21d为1个周期。[结果]12例中66．6％（8／12）PSA下降≥50％,为治疗有效;16．7％（2／12）PSA下降〈50％,为病情稳定;16．7％（2／12）PSA持续上升,为治疗无效。有骨痛的9例患者中,55．6％（5/9）骨痛缓解,平均缓解期为14．3个月。多发性颅内转移灶最大转移瘤直径由化疗前的2．5cm缩小至0．5cm．肝脏转移瘤由原来的5．0cm缩小至2．4cm,肺转移灶最大转移瘤直径由化疗前的3．2cm缩小至1．0cm．气促缓解．膀胱转移患者化疗后血尿完全消失。全组最主要的毒副反应为骨髓抑制和呕吐。[结论]多西他赛联合泼尼松3周方案治疗激素难治性前列腺癌有一定疗效,毒性可耐受。     

多西他赛、氟脲嘧啶分别联合奥沙利铂或顺铂治疗进展期胃癌的临床对照观察

目的评价多西他赛联合奥沙利铂、氟脲嘧啶（DOF方案）与多西他赛联合顺铂、氟脲嘧啶（DCF方案）组成的5d联合方案一线治疗进展期胃癌的有效性和安全性。方法75例病人分为A，B两组。A组38例，接受DOF方案治疗。DOF方案：多西他赛75mg／m^2，d2，奥沙利铂130mg／m^2，d1，氟脲嘧啶500mg／m2，d1-d5；B组37例，接受DCF方案治疗。DCF方案：多西他赛75mg／m^2，d2，顺铂25mg／m^2，dl-d3，氟脲嘧啶500mg／m^2，dl-d5。均每3wk重复，至少应用2周期。结果A组病人临床控制率、完全缓解率、部分缓解、中位治疗至进展时间、中位生存期以及1a生存率和2a的生存率分别为65．78％、5．26％、42．10％、5．9mo、11．2mo、52．63％、18．42％。B组分别为54．06％、2．70％、35．14％、5．8mo、10．8mo、48．64％、13．51％。治疗前两组生活质量（QOL）分值相当，但是治疗后1mo、2mo的QOL分值似有差异，但两组有效率与生存期比较差异并无显著性（P〉0．05）。两组主要毒副反应为骨髓抑制、恶心呕吐，但不严重。结论多西他赛联合奥沙利铂、氟脲嘧啶和多西他赛联合顺铂、氟脲嘧啶一线治疗进展期胃癌疗效均确切、毒副反应均可以接受。与最好的支持治疗相比联合化疗可延长病人生存期，提高生活质量。特别是前者对生活质量的影响比后者轻。     

米托蒽醌联合泼尼松治疗激素抵抗性前列腺癌的临床效果

目的探讨米托蒽醌联合泼尼松治疗激素抵抗性前列腺癌的临床效果。方法按照随机数字表法将90例激素抵抗性前列腺癌患者均分为实验组和对照组。实验组采用米托蒽醌联合泼尼松治疗,对照组采用多西他赛联合泼尼松治疗,比较2组患者临床疗效、骨痛缓解效果及毒副作用和不良反应发生情况。结果实验组总有效率为86.67%,与对照组(84.44%)比较,差异无统计学意义(P>0.05);实验组患者治疗有效和病情稳定患者的PSA控制时间为(25.33±7.57)周,显著低于对照组(37.88±10.26)周,差异具有统计学意义(P<0.05);实验组患者骨痛缓解率为42.22%,与对照组(53.33%)比较,差异无统计学意义(P>0.05);实验组患者骨髓抑制发生率为40.00%,不良反应发生率为6.67%,均略低于对照组(53.33%,17.78%),但差异无统计学意义(P>0.05)。结论米托蒽醌联合泼尼松治疗激素抵抗性前列腺癌临床疗效显著,与多西他赛联合泼尼松相近,但其在骨痛缓解和副作用、不良反应发生情况上略优于多西他赛联合泼尼松。当治疗效果不佳时两种方案交替使用能够有效提高治疗效果,多西他赛联合泼尼松可作为米托蒽醌联合泼尼松的挽救方案。     

米托蒽醌联合沙利度胺挽救治疗经多西他赛治疗失败的晚期去势抵抗性前列腺癌的疗效观察

目的:观察米托蒽醌联合沙利度胺挽救治疗经多西他赛治疗失败的晚期去势抵抗性前列腺癌的疗效及不良反应。方法:回顾性分析我院收治的80例经多西他赛化疗失败的晚期去势抵抗性前列腺癌患者,按治疗方法不同分为两组,观察组40例接受米托蒽醌、泼尼松联合沙利度胺方案化疗,对照组仅接受米托蒽醌、泼尼松方案化疗。每2个疗程评价疗效,计算PSA缓解率及中位进展时间、ORR及中位TTP、骨痛缓解率和不良反应。结果:80例患者均可评价疗效,观察组和对照组的PSA缓解率分别为55.0%、47.5%,中位进展时间分别为4.2个月、3.5个月,mTTP分别为4.9个月、4.1个月,骨痛缓解率分别为74.3%、51.5%,ORR均为5.0%,两组差异比较无统计学意义（P＞0.05）。观察组患者的骨髓抑制、胃肠道反应发生率稍低于对照组,但差异无统计学意义（P＞0.05）;观察组患者的失眠、消瘦症状较对照组明显得到改善,差异有统计学意义（P＜0.05）。结论:米托蒽醌、泼尼松方案挽救治疗经多西他赛治疗失败的晚期去势抵抗性前列腺癌有较好的疗效,不良反应发生率低,联合沙利度胺可进一步改善晚期患者的失眠、消瘦症状。     

激素抵抗性前列腺癌的治疗进展

多西他赛联合泼尼松的3周治疗方案是激素抵抗性前列腺癌的首选一线化疗方案.近年来许多临床研究着重于研究抗肿瘤血管生成联合多西他赛为基础的治疗方案能否进一步提高疗效、新一代抗雄激素治疗以及多西他赛化疗失败后的解救治疗.对于激素抵抗性前列腺癌,阿比特龙可为首选,Enzalutamide可作为多西他赛耐受后的另一内分泌治疗选择,而化疗联合靶向药物仍然无法挑战多西他赛联合泼尼松的一线治疗地位.     

前列腺特异性抗原动力学参数对激素难治性前列腺癌化疗疗效的预测作用

背景与目的:前列腺特异性抗原(prostate specific antigen,PSA)的动态变化往往反映疾病的预后.本研究旨住探讨PSA倍增时间(PSADT)、速率(PSAV)和最低值(nPSA)对激素难治性前列腺癌(hormonal refractory prostate cancer,HRPC)应用多西他赛/米托蒽醌联合泼尼松化疗疗效的预测作用.方法:回顾性分析68例HRPC化疗患者资料,其中多西他赛组39例,米托蒽醌组29例.统计患者nPSA并计算PSADT和PSAV,比较相关因素与化疗疗效的关系.结果:PSADT≤2个月组与＞2个月组的有效率分别为40.0%和78.6%;PSAV≤5.0 ng/(ml.mo)组与＞5.0 ng/(ml·mo)组有效率则为70.6%和41.2%,两参数各自分组比较,差异有显著性(P=0.004和0.028).nPSA≤0.4 ng/ml组与＞0.4 ng/ml组有效率相比,差异无显著性(P=0.499).多因素分析显示只有PSADT＞2.0个月与较高的有效率有关(P=0.007).临床分期、Gleason评分、诊断时PSA和化疗开始时PSA对化疗疗效无预测作用. 结论:PSADT是HRPC患者应用多西他赛/米托蒽醌联合泼尼松化疗疗效的预测因子,化疗前PSADT＞2个月患者化疗有效率高,而PSAV和nPSA对化疗疗效无预测作用.     

分子靶向药物联合多西他赛和泼尼松治疗转移性去势抵抗性前列腺癌的Meta分析

目的:系统评价分子靶向药物联合多西他赛和泼尼松治疗转移性去势抵抗性前列腺癌的疗效与安全性。方法:计算机检索Embase、Cochrane Library、PubMed、中国知网、万方数据库、维普中文科技期刊数据库和中国生物医学文献数据库,按照文献纳入标准和排除标准选择应用分子靶向药物联合多西他赛和泼尼松治疗转移性去势抵抗性前列腺癌的相关文献,评价文献质量并提取资料后,应用STATA 12.0软件进行Meta分析。其中,试验组采用分子靶向药物联合多西他赛和泼尼松治疗方案,对照组采用多西他赛联合泼尼松方案治疗。观察终点包括总生存(overall survival,OS)时间、无进展生存(progressionfree survival,PFS)时间、客观缓解率(objective response rate,ORR)、血清前列腺特异性抗原(prostate-specifi c antigen,PSA)水平、3~4级不良反应和致死性不良事件。结果:共纳入5项临床随机对照试验,总样本量为5 886例。Meta分析结果显示,分子靶向药物联合多西他赛和泼尼松组与多西他赛联合泼尼松组相比,中位PFS时间明显延长[风险比为0.93,95%可信区间(confi dence interval,CI)为0.87~0.99,P=0.018],而OS时间[风险比为0.98,95%CI为0.91~1.04,P=0.441]、ORR(比值比为1.317,95%CI为0.94~1.84,P=0.106)和PSA水平(比值比为1.073,95%CI为0.82~1.40,P=0.604)的差异均无统计学意义。在不良反应方面,试验组可使3~4级不良反应(相对危险度为1.187,95%CI为0.99~1.42,P=0.062)和致死性不良事件(相对危险度为1.298,95%CI为1.02~2.22,P=0.039)的发生率增高。结论:分子靶向药物联合多西他赛和泼尼松治疗转移性去势抵抗性前列腺癌可以延长患者的PFS时间,但是分子靶向药物可增加不良反应的发生率,在临床应用时必须加强预防和对症治疗。     

多西他赛联合FP方案治疗晚期胃癌24例近期疗效

目的 观察多西他赛联合FP方案治疗晚期胃癌的疗效和毒性。方法 多西他赛40mg静滴，d1、d8、d15；CF0．1，d1～5：5Fu 0．75，d1～5，静脉应用。每3～4wk 1周期，2～3周期为1疗程。结果 治疗晚期胃癌近期有效率66．7％，毒副反应轻微。结论 多西他赛联合FP方案治疗晚期胃癌疗效较好，毒副反应轻微，有临床应用价值。     

激素抵抗性前列腺癌化疗15例报告

目的：探讨多西紫杉醇联合泼尼松治疗内分泌治疗失败前列腺癌的应用价值。方法：入选15例非激素依赖性前列腺癌患者,给予多西紫杉醇75 mg/m^2,第1天;泼尼松5 mg bid,第1-21天,21天为1个周期,每例接受化疗6-10个周期不等。结果：本组病例随访6-87周,中位61周。其中26.7%（4/15）完全缓解,46.7%（7/15）部分缓解,20.0%（3/15）稳定,6.66%（1/15）进展。缓解和稳定患者的PSA进展中位时间是40.3周（13-67周）。8例骨痛患者中5例疼痛缓解。 中位生存期大于12个月。不良反应可耐受。结论：多西紫杉醇联合泼尼松治疗激素抵抗性前列腺癌有较好疗效,不良反应轻。     

Sequential mitoxantrone/prednisone followed by docetaxel/estramustine in patients with hormone refractory metastatic prostate cancer: results of a phase II study.

BACKGROUND: Mitoxantrone/prednisone ameliorates symptoms in hormone refractory prostate cancer (HRPC) but has no effect on survival. Docetaxel (Taxotere)/estramustine improves response but with significant toxicity. We reasoned that a sequential administration of the two regimens could be a viable alternative for delivering full doses of chemotherapy, avoiding overlapping toxicity and preserving dose intensity. PATIENTS AND METHODS: Thirty HRPC patients were treated with mitoxantrone 10 mg/m(2), day 1, every 3 weeks, plus prednisone 5 mg twice daily, for three cycles, followed by estramustine phosphate, 280 mg three times daily, days 1 to 5, plus docetaxel 75 mg/m(2), day 2, every 3 weeks for a maximum of 10 cycles. RESULTS: All patients were assessable for response and toxicity. After mitoxantrone/prednisone treatment, the prostate-specific antigen (PSA) response rate was 23%, which increased to 63% after completion of sequential mitoxantrone/prednisone and docetaxel/estramustine treatment (12 partial and 7 complete responses). With a median follow-up of 18 months, median survival for all patients was 18 months, and median progression-free survival was 10 months. The mitoxantrone/prednisone regimen was well tolerated, and the only grade 3-4 toxicity was grade 3 neutropenia in four (13%) patients. Twenty-nine patients received a total of 173 cycles of docetaxel/estramustine (median, 6 cycles/patient). Six (20%) patients had grade 3-4 neutropenia and two (6%) patients had febrile neutropenia episodes. The most frequent non-hematological toxic effects were asthenia, nausea and vomiting, edemas and onycholysis. Two (6%) patients had deep venous thrombosis. CONCLUSIONS: Mitoxantrone/prednisone followed by docetaxel/estramustine is a well-tolerated and active regimen in HRPC. Sequential therapy is feasible and can be used to integrate novel, more active regimens.     

Phase II study of sequential chemotherapy with docetaxel-estramustine followed by mitoxantrone-prednisone in patients with advanced hormone-refractory prostate cancer

Sequential chemotherapy may improve treatment efficacy avoiding the additive toxicity associated with concomitant polichemotherapy in hormone-refractory prostate cancer (HRPC). Forty patients received docetaxel 30 mg m(-2) intravenous (i.v.), weekly, plus estramustine 280 mg twice daily for 12 weeks. After 2 weeks rest, patients with a decline or stable PSA were treated with mitoxantrone 12 mg m(-2) i.v. every 3 weeks plus prednisone 5 mg twice daily for 12 cycles. Forty patients were assessable for toxicity after docetaxel/estramustine. Main toxicities were grade 3-4 AST/ALT or bilirubin increase in seven patients (17.5%) and deep venous thrombosis (DVT) in four patients (10%). Twenty-seven patients received mitoxantrone/prednisone. Main toxicities included DVT in one patient (3.7%) and congestive heart failure in two patients (7%). Thirty-nine patients were assessable for PSA response. Twenty-nine patients (72.5%; 95% CI 63-82%) obtained a >/=50% PSA decline with 15 patients (37.5%; 95% CI 20-50%) that demonstrated a >/=90% decrease. Median progression-free and overall survival were respectively 7.0 (95% CI 5.8-8.2 months) and 19.2 months (95% CI 13.9-24.3 months). In conclusion, although this regimen demonstrated a favourable toxicity profile, sequential administration of mitoxantrone is not able to improve docetaxel activity in patients with HRPC.     

Randomized phase II study of docetaxel plus estramustine and single-agent docetaxel in patients with metastatic hormone-refractory prostate cancer.

BACKGROUND: Docetaxel (Taxotere)-based regimens are the new standard therapy in advanced hormone-refractory prostate cancer (HRPC). A synergistic activity has been shown with docetaxel in combination with estramustine in vitro; however, the benefit of this combination remains controversial in clinical practice. We assessed the activity and safety of docetaxel alone and docetaxel-estramustine in HRPC. PATIENTS AND METHODS: Patients (n = 92) with metastatic HRPC and rising prostate-specific antigen (PSA) while receiving androgen suppression were randomized to 3-weekly treatment with either docetaxel 75 mg/m(2), day 1 (D), or docetaxel 70 mg/m(2), day 2, plus oral estramustine 280 mg twice daily, days 1-5 (DE). RESULTS: Ninety-one patients were treated (DE 47, D 44). A PSA response occurred in 68% (primary endpoint met) and 30% of patients, respectively. Median PSA response duration was 6.0 months in both groups. Median time to progression was 5.7 and 2.9 months, and median survival was 19.3 and 17.8 months in the DE and D arms, respectively. Hematologic and non-hematologic toxic effects were mild and similar in both arms. One patient in each group withdrew due to toxicity. Quality of life was similar in both groups. CONCLUSION: Combining estramustine with docetaxel in this schedule is an active and well-tolerated treatment option in HRPC.     

Docetaxel, low-dose estramustine, and doxifluridine in hormone-refractory metastatic prostate cancer

Purpose Advanced prostate cancer, which is one of the most common cancers, usually progresses to hormone-refractory prostate cancer (HRPC). A recent randomized trial of treatment with docetaxel demonstrated improved survival for patients with HRPC. The combination of docetaxel and estramustine phosphate (estramustine) has been reported to be effective for HRPC. Low-dose estramustine suppresses the pituitary–gonadal axis. Docetaxel plus 5-fluoro-5′-deoxyuridine (5′-dFUrd) had supra-additive cytotoxic effects on HRPC cells consistent with the molecular mechanism. Therefore, we examined the efficacy of adding 5′-dFUrd on the chemotherapy regimen, which consist docetaxel and estramustine. Methods All of the HRPC patients were treated with estramustine 140 mg orally twice 5′-dFUrd 200 mg orally four times daily on days 1–21, and docetaxel 60 mg/m² was administered on day 1. We evaluated serum prostate-specific antigen (PSA) and measurable responses, the progression-free and overall survival, and the impact on adverse effects and the quality of life (QOL). Results Of 34 patients with a median age of 72.3 years, 73% showed PSA responses and 70% showed measurable responses. The median progression-free survival was 18.0 and 5.8 months for PSA responders and non-responders and the overall survival was 19.4 months, respectively. There were few serious adverse effects. Grade 3/4 neutropenia occurred in 32.4% of the patients, and was easily managed with granulocyte colony-stimulating factor (G-CSF) injection. There was no significant change in the overall QOL scores serially. Conclusions This study shows that the combined regimen is tolerable and effective in Japanese HRPC patients.     

Recent progress in management of advanced prostate cancer

Androgen-deprivation therapy, usually with combined androgen blockade, is standard initial treatment for advanced prostate cancer. With failure of initial treatment, as indicated by rising prostate-specific antigen (PSA) levels, second-line hormonal therapy is usually instituted. Over the past several years, it has become increasingly clear that systemic chemotherapy has an important role in hormone-refractory disease. Phase II trials have demonstrated high PSA and measurable disease response rates with taxane single-agent and combination treatments. One recent phase III trial showed that docetaxel (Taxotere)/ estramustine (Emcyt) significantly improved overall survival, progression-free survival, and PSA response rate compared with mitoxantrone (Novantrone) plus prednisone. Another phase III trial demonstrated that docetaxel given every 3 weeks plus prednisone significantly improved overall survival, PSA response rate, pain relief response rate, and quality of life compared with mitoxantrone and prednisone. On the basis of these findings, every-3-week docetaxel plus prednisone is now considered standard first-line therapy for metastatic hormone-refractory disease. There is considerable optimism that treatment can be further improved. Studies of taxane combinations with bevacizumab (Avastin), thalidomide (Thalomid), bortezomib (Velcade), antisense Bcl-2 oligonucleotide, mTOR inhibitors, epidermal growth factor receptor inhibitors, and KDR inhibitors are under way. Randomized phase III trials in progress or planned are examining docetaxel in combination with imatinib mesylate (Gleevec) or calcitriol and docetaxel/prednisone in combination with bevacizumab and an antisense clusterin compound. Other promising systemic agents include epothilones and atrasentan, and promising vaccines include Provenge, GVAX, and Prostvac.     

Oxaliplatin plus gemcitabine as a salvage schedule for hormone-refractory prostate adenocarcinoma

We report a case of hormone-refractory prostate cancer (HRPC) treated with oxaliplatin plus gemcitabine in a third-line schedule after liver progression, with an excellent clinical, biochemical and radiological response and with an acceptable tolerance. Prior chemotherapy regimens included docetaxel plus estramustine and oral etoposide. To our knowledge, this is the first report that shows this approach in an HRPC patient.     

Achieving treatment goals for hormone-refractory prostate cancer with chemotherapy

The belief that hormone-refractory prostate cancer (HRPC) is a chemotherapy-resistant disease has been effectively refuted by the results of two recent randomized phase III trials. The TAX327 trial compared weekly docetaxel, every-3-weeks (Q3W) docetaxel, and Q3W mitoxantrone plus prednisone in 1,006 patients with HRPC, and results demonstrated that survival was significantly longer with a docetaxel-based regimen than with mitoxantrone. That trial demonstrated that only Q3W docetaxel was significantly superior to mitoxantrone with respect to overall survival. Quality of life was also superior in the docetaxel groups. In the Southwest Oncology Group (SWOG) 9916 trial, 674 men with progressive HRPC were randomized to 3-week cycles of docetaxel plus estramustine or mitoxantrone plus prednisone. Overall and disease-free survival times were significantly longer in the docetaxel arm. Collectively, the results of these trials demonstrate that survival can be significantly improved with chemotherapy in patients with HRPC to an extent that is comparable with the survival benefits seen in other cancers considered sensitive to chemotherapy such as breast cancer. Among various research tasks in HRPC is the definition of potential surrogate end points for survival, which will facilitate the conduct of pivotal trials. Prostate-specific antigen (PSA) response rate and changes in PSA constructs (i.e., PSA doubling time and PSA velocity) are promising potential surrogate end points for future trials and are being actively evaluated at the present time. Until there is clear demonstration of a surrogate role for these alternative end points, survival remains the appropriate end point for phase III trials in HRPC. There is a need for safe and effective second- and third-line regimens for patients progressing after docetaxel, and these patients should enter clinical trials designed for this population. Mitoxantrone, vinorelbine, the platinum analogue satraplatin, and epothilone are among compounds that require careful testing in this setting. The addition of targeted therapies, such as the endothelin receptor antagonist, atrasentan, and angiogenesis inhibitors, such as thalidomide and bevacizumab, to docetaxel-based therapy is being evaluated. High-dose calcitriol may also be an effective addition to docetaxel. The extensive effort devoted to the evaluation of chemotherapy and other systemic modalities of treatment of HRPC is likely to yield additional clinical benefit for patients, making HRPC a more manageable, less lethal, and less debilitating disease.     

Cabazitaxel: filling one of the gaps in the treatment of prostate cancer

Prostate cancer is the second most frequently diagnosed cancer in men and the fifth most common cancer overall. Globally, more than 900,000 new cases of prostate cancer will be diagnosed in 2010 and more than 260,000 will, unfortunately, die from the disease. In the US, an estimated 217,000 new cases of prostate cancer and 32,000 deaths are expected this year. Definitive therapy (surgery or radiation) is highly effective, but if the tumor escapes the gland, treatment options are limited. For this population of patients, androgen suppression is the cornerstone of initial therapy. Furthermore, progression to castration resistant prostate cancer (CRPC) is inevitable. The current front-line treatment for patients with CRPC is the chemotherapeutic agent docetaxel (administered every 3 weeks). Until now, it is the only agent that has been shown to prolong survival in CRPC. The approval trial for docetaxel found a median overall survival of 19.2 months for patients receiving docetaxel plus prednisone compared to 16.3 months for patients receiving mitoxantrone plus prednisone (p=0.0094). Mitoxantrone plus prednisone is often utilized for its palliative benefits, but two randomized trials failed to demonstrate a survival advantage.