Randomized Phase-II Trial of Abiraterone Acetate Plus LHRH-therapy Versus Abiraterone Acetate Sparing LHRH-therapy in Patients With Progressive Chemotherapy-naïve Castration-resistant Prostate Cancer (SPARE)
概览
- 阶段
- 2 期
- 干预措施
- abiraterone acetate + prednisone + LHRH-therapy
- 疾病 / 适应症
- Prostate Cancer
- 发起方
- Universität des Saarlandes
- 入组人数
- 68
- 试验地点
- 20
- 主要终点
- radiographic-progression-free survival
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
This is an exploratory Phase 2 multicenter, randomized, open-label study with a randomization allocation ratio of 1:1 [abiraterone acetate + prednisone + LHRH-therapy (Arm A) versus abiraterone acetate + prednisone (Arm B)]. For both groups patients will receive a dose of 1000 mg abiraterone acetate and 10mg prednisone daily (QD). Study drug will be administered as 4 x 250-mg abiraterone acetate tablets and prednisone will be administered as 5 mg orally twice a day (BID). Patients randomized to the LHRH-therapy group will receive the same LHRH-therapy they received prior to entering the trial. 70 medically castrated male patients with metastatic CRPC who have shown tumor progression and are non- or mildly-symptomatic will be enrolled from approximately 12 German study sites.
研究者
入排标准
入选标准
- •Willing and able to provide written informed consent
- •Written Data Protection Consent has been obtained
- •Male aged 18 years and above
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Metastatic disease documented by positive CT/MRI and/or bone scan (both must be performed). If lymph node metastasis is the only evidence of metastasis, it must be ≥2 cm in diameter
- •Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria
- •Asymptomatic or mildly symptomatic from prostate cancer. A score of 0-1 for the question of worst pain within last 24 hours (Appendix 8) will be considered asymptomatic, and a score of 2-3 will be considered mildly symptomatic.
- •Medically castrated, with testosterone levels of \<20-50 ng/dl (\< 2.0 nM).
- •Combined androgen blockade is permitted, but not required. If patients received combined androgen blockade with an anti-androgen they must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (≥4 weeks since last flutamide, ≥6 weeks since last bicalutamide or nilutamide).
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2 (Appendix 6)
排除标准
- •Surgical castration (i.e. orchiectomy).
- •Application of any LHRH-therapy (LHRH-analogue or LHRH-antagonist) within 3 months (for patients receiving a 3-months formulation) or 1 months (for patients receiving a 1-month formulation) prior to Cycle 1 day
- •Patients receiving a 6- or 12-months formulation of LHRH-therapy
- •Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
- •Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid.
- •Pathological finding consistent with small cell carcinoma of the prostate
- •Liver or visceral organ metastasis
- •Known brain metastasis
- •Use of opiate analgesics for cancer-related pain, including codeine, tramadol, tilidin and others (see Appendix 9), currently or anytime within 4 weeks of Cycle 1 Day
- •Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
研究组 & 干预措施
abiraterone acetate + prednisone + LHRH-therapy
Patients randomized to this group will continue their LHRH-therapy.
干预措施: abiraterone acetate + prednisone + LHRH-therapy
abiraterone acetate + prednisone
Patients randomized to this group will stop LHRH-therapy.
干预措施: abiraterone acetate + prednisone
结局指标
主要结局
radiographic-progression-free survival
时间窗: 12 month
The primary objective of the study is to analyze the clinical benefit of abiraterone acetate plus prednisone while sparing LHRH-therapy in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC).
次要结局
- Correlation of radiographic-progression-free survival with early PSA-response(12 month)
- Hormonal analyses(12 month)
- Adverse Events(12 month)