A Randomized, Open-label, Multicenter, Parallel Group Treatment, Phase 3, Two-arm Study to Measure the Effect on Overall Survival and Quality of Life of Immediate Curative Therapy Compared With Standard Conservative Treatment in Older Male Participants Aged ≥ 75 Years With Non-metastatic, High-risk Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 980
- 试验地点
- 26
- 主要终点
- Overall survival
研究概览
简要总结
It is currently unclear if immediate curative treatment (radiotherapy or surgery) of high-risk prostate cancer without metastasis in older men (>=75 years) generates the same survival benefits as in younger patients or if the harms/ side-effects of immediate curative treatment outweigh the benefits. In this study the investigators randomize older patients with high-risk, non-metastatic high-risk prostate cancer to either immediate curative therapy or to conservative, more problem-oriented therapy to investigate if immediate curative treatment prolongs life, improves quality of life and is cost-effective.
详细描述
There is a lack of both level 1 evidence and consensus regarding the optimal treatment strategy for older men (>=75 years) with non-metastatic, high-risk prostate cancer. Currently, in Scandinavia, the majority of older patients are treated conservatively, i.e. with hormone therapy or watchful waiting while some centers recommend immediate curative therapy regardless of patient age. Older patients thus risk both undertreatment and overtreatment of their cancer. This randomized clinical trial investigates if immediate curative therapy of high-risk, non-metastatic prostate cancer prolongs life (as it does in younger patients) and improves health-related quality of life. Furthermore, this trial investigates if the early side effects of immediate curative therapy are compensated by better long-term tumor control, better quality of life, functional status and improved survival.
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
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participant must be 75 years of age or older, at the time of signing the informed consent.
- •Participants who are healthy as determined by medical evaluation and geriatric G8/ miniCOGTM evaluation (G8: Fit, score >14, or reversibly frail; miniCOGTM: score >2)
- •And who have PCa (diagnosed ≤6 months) with one or both of the following features:
- •Gleason grade 8-10 (ISUP group 4 and 5) other than microscopic, low-volume disease (tumor must be either palpable or visible on MRI, i.e., PIRADS 4 or 5)
- •Locally advanced PCa (T3 or T4) (unequivocal findings of clinical/ radiological T3 or clinical/ radiological T4 on DRE or MRI; broad capsular contact of tumor on MRI is treated as localized disease, T2, in the context of this study)
- •Able to read, understand and fill in HRQoL questionnaires (PROMS)
- •Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Medical Conditions
- •Dementia (unable to consent) Prior/Concomitant Therapy
- •Prior radiation to the pelvis
- •Hormone therapy >3 months prior to randomization Diagnostic assessments
- •Lymph node metastasis (N0) on MRI, CT or PSMA-PET CT (equivocal N-findings =N0; borderline cases will be discussed and called by a study tumor board).
- •Distant metastasis (M0) on MRI, CT, bone scan or PSMA-PET CT (equivocal bone scan findings need to be confirmed with MRI or CT; borderline cases will be discussed by a study tumor board).
- •Other Exclusions
- •Disabled or severe comorbidity (identified by G8 screening)
- •Unable to read, understand or fill out HRQoL questionnaires (PROMS)
研究组 & 干预措施
immediate curative therapy
Patients randomized to the intervention arm will receive immediate curative therapy in the form of either radiotherapy to the prostate in combination with hormone therapy (ADT or monotherapy) or surgery (radical prostatectomy). Standard treatment in this arm is radiotherapy + hormone therapy. Surgery is reserved for patients with strong preferences against radiotherapy.
干预措施: Radiotherapy or surgery (Radiation)
initial observation/ hormone therapy
Patients in this arm will either be observed (with localized high-risk prostate cancer) or receive hormone therapy (locally advanced prostate cancer; ADT or monotherapy). Further local or systemic therapy is given at doctor's discretion triggered by local or/ and systemic progression.
干预措施: initial observation (Other)
initial observation/ hormone therapy
Patients in this arm will either be observed (with localized high-risk prostate cancer) or receive hormone therapy (locally advanced prostate cancer; ADT or monotherapy). Further local or systemic therapy is given at doctor's discretion triggered by local or/ and systemic progression.
干预措施: Hormone therapy (Drug)
结局指标
主要结局
Overall survival
时间窗: 10 years following end of recruitment
overall survival
Burden of disease
时间窗: 0-10 years
European Organisation for Research and Treatment of Cancer questionnaire for assessment of health-related quality of life elderly patients with cancer (EORTC ELD 14), burden of disease scale (2 questions, score 0-100, high scores indicate high burden of disease)
次要结局
- Role functioning(0-10 years)
- bowel symptoms(0-10 years)
- Prostate cancer morbidity(0-10 years)
- Urinary irritative/ obstructive symptoms(0-10 years)
- Prostate-cancer-specific survival(0-10 years)
- Metastasis-free survival(0-10 years)
- Symptom-/ intervention-free survival(0-10 years)
- Quality of life-adjusted years(0-10 years)
- need for secondary and tertiary therapy(0-10 years)
研究者
Sven Löffeler
Principal investigator
The Hospital of Vestfold