Phase II Study of Bicalutamide and Dutasteride for Prostate Cytoreduction Prior to Permanent Implant I-125 Prostate Brachytherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total prostate volume
研究概览
简要总结
The purpose of this study is to determine if a combination of neoadjuvant dutasteride and bicalutamide has the same efficacy and less toxicity than standard treatment with an LHRH agonist and bicalutamide for prostate cytoreduction prior to permanent implant brachytherapy.
详细描述
Permanent implant prostate brachytherapy is recognized as the treatment method for prostate cancer that results in the least amount of sexual side effects including erectile dysfunction (ED). However prostate brachytherapy is often limited to patients with a prostate volume less than 50cc because of dosimetric and technical considerations. To counter this fact patients with a prostate larger than 50cc are offered neoadjuvant hormonal therapy to reduce their prostate volume to a value less than 50cc. The pharmacological method most often employed involves treatment with an LHRH agonist, which also involves multiple adverse effects for patients including ED in the majority of patients.
This approach may also involve other disadvantages including a possibility of increased cardiovascular mortality a possible increase in urinary toxicity and a reduction in health-related quality of life in patients treated with neoadjuvant hormonal therapy. Despite theses facts, neoadjuvant hormonal therapy remains essentially the sole method used to reduce prostate volume prior to prostate brachytherapy. One study has evaluated the efficacy of a neoadjuvant regimen without an LHRH agonist, comprised of Dutasteride and Bicalutamide to reduce prostate volume. This treatment could theoretically have fewer effects on sexual function and quality of life and could also possibly reduce urinary toxicity of brachytherapy. Nonetheless, these factors have never been evaluated. The cytoreductive efficacy of Bicalutamide and Dutasteride have never been directly compared to standard treatments. The current study is necessary to determine the effects of a neoadjuvant regimen of Bicalutamide and Dutasteride on prostate volume, sexual function, urinary toxicity and quality of life as compared to standard treatment. If it can be determined that there is an advantage with Bicalutamide and Dutasteride this regimen could become a standard of care for prostate cytoreduction prior to brachytherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of prostate adenocarcinoma as confirmed by prostate biopsy
- •Prostate cancer with stage T1a, T1b T2a or T2b Nx Mx as determined by clinical examination
- •Gleason score of 6 or less or 7 (3+4)*
- •* If Gleason score is 7(3+4) patient must have less than 30% of biopsied tissue positive
- •Serum PSA of ≤ 15ng/ml during the month before study entry
- •Prostate volume ≥ 45cc
- •Normal serum testosterone during the month before study entry
- •Availability for treatment and follow-up visits
- •Having signed required consent form before study entry
排除标准
- •Abnormal Liver Function tests (>2x normal AST or ALT and/or >1.5x normal bilirubin)
- •Prostate volume less than 50 cc
- •History of hormonal treatment including any of the above: LHRH agonists, antiandrogens during the year before study entry
- •Use of a 5 alpha reductase inhibitor for more than one month during the year prior to study entry
- •History of pelvic irradiation
- •History of past chemotherapy
- •History of TURP
- •History of past treatment for prostate cancer
- •Known hypersensitivity to Dutasteride or Bicalutamide
- •Co-morbid disease possibly compromising treatment compliance
- •History of DVT or pulmonary embolism
- •Anticoagulation with coumarin
- •Inability to give consent
研究组 & 干预措施
LHRH agonist
Administration of a 3-month treatment with an LHRH agonist (chosen by the treating radiation oncologist) and Bicalutamide 50 mg daily for the first month of treatment with the LHRH agonist.
干预措施: administration of a LHRH agonist and Bicalutamide (Drug)
Dutasteride, Bicalutamide, Tamoxifen
Administration of Dutasteride given at dose of 0.5 mg daily starting three months prior to day of implant procedure and continued for 3 months up until procedure.
Bicalutamide: given at a dose of 50 mg daily for 3 the same 3 month period as dutasteride
Tamoxifen: given at dose of 10 mg daily for 3 months that dutasteride and bicalutamide are administered.
干预措施: administration of Bicalutamide, Dutasteride and Tamoxifen (Drug)
结局指标
主要结局
Total prostate volume
时间窗: 3 months after start of therapy
Trans rectal ultra sound 3 dimensional volume evaluation
次要结局
- EPIC questionnaire sexual function and bother scores(baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant)
- Anemia(baseline, pre-implant, 3,6,12,18 and 24 months post-implant)
- EPIC questionnaire urinary function and bother scores(baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant)
- IPSS scores(baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant)
- Acute urinary retention rates(0 to 6 months post-implant)
- EPIC questionnaire bowel function and bother scores(baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant)
- EPIC questionnaire hormonal function and bother scores(baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant)
- Rate of gynecomastia and breast tenderness(6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant)
- Serum testosterone(3 months pre-implant, pre-implant, 3,6,12,18 and 24 months post-implant)
- SF-12 Quality of life questionnaire results(baseline, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant)
- Abnormal liver function tests(6 weeks pre-implant, pre-implant, 3 months post-implant)
- Serum PSA(baseline, pre-implant, 3,6,12,18 and 24 months post-implant)
- Adverse events recording(6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant)
研究者
André-Guy Martin
MD MSC FRCP(C) Radio-oncologue, Curiethérapeute Professeur Associé, Université Laval
CHU de Quebec-Universite Laval