A Single Arm Prospective Study to Investigate the Impact of Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) on Sexual Dysfunction in Unfavorable Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change in erectile dysfunction severity from baseline to 24 months, as measured by the change in International Index of Erectile Function 5-item version (IIEF-5) score.
研究概览
简要总结
This study looks at how combined radiation and hormone therapy affects sexual function in men with a specific type of prostate cancer, before and after treatment.
详细描述
This study examines how two standard combination treatment for prostate cancer - a highly targeted form of radiation called Stereotactic Body Radiation Therapy (SBRT) and a hormone-blocking treatment called Androgen Deprivation Therapy (ADT) - impact sexual function in men with unfavorable intermediate risk prostate cancer. Participants will complete study questionnaires before treatment or Baseline, and after treatment, on Month 3, 9, 15, and 24.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 18-80 years with biopsy-proven UIR-PCa (National Comprehensive Cancer Network [NCCN] criteria: Gleason score 7 (4+3), PSA 10-20 ng/mL, or clinical stage T2b-T2c)
- •Planned treatment with SBRT (36.25-37.5 Gy in 5 fractions) and ADT (6 months)
- •Baseline sexual function assessment available (International Index of Erectile Function [IIEF-5, also known as SHIM] score ≥ 12 or pre-selection erection status score of 1-3: erection insufficient for intercourse, sufficient but not optimal, or normal)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Written informed consent to participate.
排除标准
- •Prior pelvic radiotherapy, prostate surgery, ADT, or chemotherapy
- •Pre-existing severe sexual dysfunction (IIEF-5 score < 12 or pre-selection erection status score of 0: no erection)
- •Hypogonadism at presentation (baseline testosterone below normal range)
- •Contraindications to SBRT or ADT
- •Metastatic disease, second malignancy, or previous malignancies.
- •Benign or malignant penile diseases.
- •Use of medications altering ejaculation (e.g., 5-alpha reductase inhibitors)
- •Psychiatric conditions affecting questionnaire completion or QoL assessment
- •Severe comorbidities affecting QoL assessments (e.g., advanced cardiovascular disease).
研究组 & 干预措施
Observational
Prostate cancer patients receiving SBRT and ADT
干预措施: SBRT combined with ADT (Combination Product)
结局指标
主要结局
Change in erectile dysfunction severity from baseline to 24 months, as measured by the change in International Index of Erectile Function 5-item version (IIEF-5) score.
时间窗: Baseline, 3, 9, 15, and 24 months post-SBRT
Outcome Measure Title: Change in Erectile Function Score as Measured by the International Index of Erectile Function-5 (IIEF-5 / SHIM) Measurement Tool: International Index of Erectile Function-5 (IIEF-5, also known as SHIM) Unit of Measure: Total IIEF-5 score (range 1-25; higher scores indicate better erectile function) Derived Unit: Change in IIEF-5 score from baseline to 24 months (continuous variable, points)
次要结局
- Proportion of patients with clinically significant (moderate to severe) erectile dysfunction(Baseline, 3, 9, 15, and 24 months)
- Change in sexual function, as measured by the Expanded Prostate Cancer Index Composite 26-item version (EPIC-26) sexual domain score(Baseline, 3, 9, 15, and 24 months)
- Hormonal Domain Score of the Expanded Prostate Cancer Index Composite (EPIC-26)(Baseline, 3, 9, 15, and 24 months)
- Ejaculatory Function Score as Measured by the Male Sexual Health Questionnaire - Ejaculation Scale (MSHQ-ES-8)(Baseline, 3, 9, 15, and 24 months)
- Health-Related Quality of Life Score as Measured by EORTC QLQ-ELD14(Baseline, 3, 9, 15, and 24 months (for patients >70 years))
研究者
Dr. Vibhay Pareek
Radiation Oncologist
CancerCare Manitoba