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临床试验 NCT07460726 (PRIAPUS-PCa) 针对前列腺腺癌，Erectile Abnormalities，男性性功能障碍目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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PRIAPUS-PCa Study: Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) Impact on Sexual Function on Men With Unfavorable Intermediate Risk Prostate Cancer 130
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临床试验NCT07460726 (PRIAPUS-PCa)是一项针对前列腺腺癌，Erectile Abnormalities，男性性功能障碍的观察研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年3月16日开始，预计招募130名患者。该研究由CancerCare Manitoba主导，计划于2029年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月10日。
简要概括
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 treatm...显示更多
官方标题
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
疾病
前列腺腺癌Erectile Abnormalities男性性功能障碍出版物
关于此临床试验发表的科学文章和研究论文：- Vickers AJ, Elkin EB. Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making 2006;26:565. https://doi.org/10.1177/0272989X06295361.
- Balachandran VP, others. Nomograms in oncology: more than meets the eye. Lancet Oncol 2006;2015:e173-80. https://doi.org/10.1016/S1470-2045(14)71116-7.
其他研究标识符
- PRIAPUS-PCa
- 1219
NCT编号
实际开始日期
2026-03-16
最近更新发布
2026-03-10
预计完成日期
2029-12-31
计划入组人数
130
研究类型
观察研究
试验状态
尚未招募
关键词
Prostate cancer
sexual function
SBRT
ADT
sexual function
SBRT
ADT
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Observational Prostate cancer patients receiving SBRT and ADT | SBRT combined with ADT SBRT combined with Zoladex |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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. | 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) | Baseline, 3, 9, 15, and 24 months post-SBRT |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Proportion of patients with clinically significant (moderate to severe) erectile dysfunction | Measurement Tool:
IIEF-5 (SHIM)
Unit of Measure:
Percentage (%) of patients with IIEF-5 score ≤ 11 | 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 | Measurement Tool:
EPIC-26 Questionnaire - Sexual Domain
Unit of Measure:
Standardized domain score (0-100 scale; higher scores indicate better sexual function) | Baseline, 3, 9, 15, and 24 months |
Hormonal Domain Score of the Expanded Prostate Cancer Index Composite (EPIC-26) | Measurement Tool:
EPIC-26 Questionnaire - Hormonal Domain
Unit of Measure:
Standardized domain score (0-100 scale; higher scores indicate better hormonal function) | Baseline, 3, 9, 15, and 24 months |
Ejaculatory Function Score as Measured by the Male Sexual Health Questionnaire - Ejaculation Scale (MSHQ-ES-8) | Measurement Tool:
Male Sexual Health Questionnaire - Ejaculation Scale (ES-8)
Unit of Measure:
Total ES-8 score (range 3-40; higher scores indicate worse ejaculatory function) | Baseline, 3, 9, 15, and 24 months |
Health-Related Quality of Life Score as Measured by EORTC QLQ-ELD14 | Measurement Tool:
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Elderly Module (EORTC QLQ-ELD14)
Unit of Measure:
Standardized subscale scores (0-100 scale):
Functional scales (higher = better functioning)
Symptom scales (higher = greater symptom burden) | Baseline, 3, 9, 15, and 24 months (for patients >70 years) |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
男性
- 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 0-1.
- Written informed consent to participate.
- 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).
CancerCare ManitobaTerSera Therapeutics LLC研究责任方
Dr. Vibhay Pareek, 主要研究者, Radiation Oncologist, CancerCare Manitoba
研究中心联系人
联系人: Zoe Ignacio, RN, BN (BScN), 1-204-787-2955, [email protected]
1 位于 1 个国家/地区的研究中心
Manitoba
Manitoba Prostate Centre, Winnipeg, Manitoba, R3E 0V9, Canada
Zoe Ignacio, RN, BN (BScN), 联系人, 1-204-787-2955, [email protected]
Vibhay Pareek, MD, FRCPC, 主要研究者