A Pilot Study of MRI and Spectroscopy Imaging Changes With 6-months of Dutasteride in Patients With Symptomatic Benign Prostatic Hypertrophy and Low-risk Prostate Cancer on Watchful Waiting or Requiring Neoadjuvant Androgen Suppression Prior to Prostate Brachytherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Extent of Cancer
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as MRI and magnetic resonance spectroscopy imaging, may help in learning how well dutasteride works in patients with benign prostatic hypertrophy and low-risk prostate cancer.
PURPOSE: This clinical trial is studying MRI and magnetic resonance spectroscopy imaging in patients receiving dutasteride for benign prostatic hypertrophy and low-risk prostate cancer.
详细描述
OBJECTIVES:
Primary
- To determine whether there is a decrease in the extent of prostate cancer as measured by endorectal MRI and magnetic resonance spectroscopy imaging in patients with symptomatic benign prostatic hypertrophy and low-risk prostate cancer treated with dutasteride for 6 months.
Secondary
- To monitor the effects of dutasteride on serum testosterone, dihydrotestosterone, and free and total prostate-specific antigen (PSA).
- To monitor the effects of dutasteride on symptom and quality-of-life indices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Other prior or concurrent invasive cancer, other than localized basal cell or squamous cell carcinoma of the skin
- •Contraindications to MRI/MRSI, including any of the following:
- •Prostate biopsy (within the past 8 weeks) and any continued post-biopsy bleeding
- •Rectal bleeding
- •Anal fissures
- •Rectal surgery (end-to-end anastomosis)
- •Inflammatory bowel disease
- •Prior radical prostatectomy
- •Hip replacement
- •Certain types of penile implants
- •Vascular clips
- •Known anaphylactic reaction to latex compounds
- •Anticoagulant drugs
- •Severe claustrophobia
- •Cardiac pacemaker
- •Metal in eye
- •Any other metallic or foreign object in the body
- •Unstable serious co-morbidities including, but not limited to, myocardial infarction, coronary artery syndrome, cardiac arrhythmias, symptomatic congestive heart failure, or cerebrovascular accident
- •Major medical or psychiatric illness that, in the investigator's opinion, would preclude the completion of treatment and interfere with follow up
- •Known hypersensitivity to any 5α-reductase inhibitor or drug chemically related to the study drug
- •Prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
- •Prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- •Prior or concurrent cytotoxic chemotherapy for prostate cancer
- •Prior hormonal therapy, such as luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide acetate), antiandrogens (e.g., flutamide or bicalutamide), or estrogens (e.g., diethylstilbestrol)
- •Prior or concurrent finasteride, dutasteride, other drugs with known antiandrogenic properties (e.g., spironolactone or progestational agents), or any dietary or herbal supplement (e.g., selenium, vitamin E, saw palmetto, or PC-SPES)
研究组 & 干预措施
Dutasteride
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
干预措施: dutasteride (Drug)
结局指标
主要结局
Change in Extent of Cancer
时间窗: 1 month, 6 months
Proportion of voxels consistent with prostate cancer as measured by magnetic resonance spectroscopy imaging (MRSI). MRSI spectra were examined and scored as healthy or cancerous. The change in cancerous volumes over time was evaluated. 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, primary comparisons were made between the 1-month and 6-month scans.
次要结局
- Symptom Indices Over Time - IIEF-5(Baseline, 1, 3, and 6 months)
- Health-Related Quality of Life (HRQL) Indices Over Time - SQLI(Baseline, 1, 3, and 6 months)
- Health-Related Quality of Life (HRQL) Indices Over Time - FACE(Baseline, 1, 3, and 6 months)
- Total PSA Over Time(Baseline, 1, 3, and 6 months)
- Symptom Indices Over Time - IPSS(Baseline, 1, 3, and 6 months)
- Adverse Events Indicative of Safety of Dutasteride(Baseline, 1, 3, and 6 months)
- Dihydrotestosterone (DHT) Over Time(Baseline, 1, 3, and 6 months)
- Testosterone Over Time(Baseline, 1, 3, and 6 months)