Imperial Prostate 4: Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 17
- 主要终点
- Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B
研究概览
简要总结
Men diagnosed with significant cancer confined to the prostate currently undergo radical therapy directed to the whole prostate (radiotherapy or prostatectomy). These provide good cancer control but can cause significant side effects.
Focal Therapy involves targeting the cancer alone, whilst leaving healthy prostate gland alone. Case series have shown similar cancer control over 5 years with a much better side effect profile. However, there have been no randomised control trials (RCTs) comparing the success in cancer control and the quality of life in patients that undergo radical therapy vs those that undergo focal therapy. Further, there is a need to assess the use of additional therapies that may improve the cancer control outcomes following focal therapy. By having a trials platform with two RCTs (CHRONOS-A and CHRONOS-B) that reflect best patient and physician preferences/ equipoise, the investigators aim to answer these questions.
To improve acceptability, recruitment and compliance, the investigators have an embedded study aimed at reviewing clinician and patient perspectives and trial acceptability. CHRONOS-A will compare radical therapy to focal therapy, whilst CHRONOS-B will compare focal therapy alone to focal therapy with various therapies targeting the testosterone pathway that can shrink the cancer before it is treated. The investigators think this might improve outcomes further for men that definitely want focal therapy.
详细描述
AIM:
CHRONOS-A
Pilot: To determine if men will agree to participate in a randomised controlled trial that randomly assigns them to focal therapy alone or radical therapy (radiotherapy or prostatectomy).
Main: To determine if focal therapy alone is non-inferior when compared to radical therapy (radiotherapy or surgery) in terms of progression-free survival at 5 years in men with clinically significant non-metastatic cancer.
CHRONOS-B
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •PSA </=20ng/ml
- •Patients must have undergone a diagnostic pre-biopsy MRI compliant with national uro-radiology consensus guidelines. Dynamic contrast enhancement using gadolinium is not required at diagnostic stage. However, contrast enhancement MRI will be required in those men who undergo focal therapy prior to focal therapy as a baseline for comparison during follow-up. In the absence of a compliant MRI (for clinical or other reasons), a transperineal template mapping biopsy using a 5-10 mm sampling frame will be required
- •Histologically proven prostate adenocarcinoma
- •Overall Gleason score of 7 (either 3+4=7 or 4+3=7) of any length or Gleason 3+3=6 provided >/=6mm cancer core length in any one core. Patients with Gleason 4+4=8 in some cores but where the overall Gleason score is 7 will be included.
- •Bilateral histologically proven prostate cancer is permissible provided the following criteria are met:
- •The index lesion to be treated if focal therapy is used meets the above histological criteria.
- •The patient may have a PIRADS or Likert score 3, 4, 5 mpMRI lesion on the same hemi-gland (either right/left or anterior/posterior) as the histological index lesion
- •Secondary areas of Gleason 3+3=6 of </=5mm cancer outside of the treatment field can be monitored, if present, and patient undergoes focal therapy.
- •If a Likert or PIRADS score 3,4 or 5 mpMRI lesion is present in an area outside of the treatment field with a negative biopsy for cancer then pathology must be reviewed and confirm the presence of inflammation or atrophy if the patient is to undergo focal therapy*
- •Radiological stage T2b/T3a will require central review regarding suitability for focal therapy.
- •Index tumour volume, as seen on mpMRI if carried out, will be restricted to 50% of one lobe for either unilateral or bilateral ablation, patients with tumour volume >/=50% of one lobe will require central review prior to enrolment. Final decisions on suitability of focal therapy will lie with the trial central review in these cases.
- •No restriction exists in CHRONOS-A on previous or current use of 5-alpha reductase inhibitors or anti-androgens or LHRH agonists or LHRH antagonists.
- •Age at least 18 years of age
- •Participants must be fit to undergo all procedures listed in the protocol as judged by clinical team
排除标准
- •Previous or current LHRH agonist or LHRH antagonist or anti-androgen use in CHRONOS-B.
- •Patients already established on a 5 alpha-reductase inhibitor (finasteride or dutasteride) who wish to go into CHRONOS-B will need to discontinue this for at least 6 months prior to randomisation. (NB: testosterone supplementation is permitted)
- •Previous treatment for prostate cancer
- •Life expectancy is likely to be less than 10 years
- •Unable to give informed consent
结局指标
主要结局
Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B
时间窗: 12 months
To assess the acceptance of randomisation to the allocated arm within CHRONOS A \& CHRONOS B separately using rates of compliance, and rates of withdrawal
Pilot: Recruitment Rate to CHRONOS A & CHRONOS B and Their Corresponding 95% Confidence Intervals
时间窗: 12 months
To estimate the recruitment rate to CHRONOS A \& CHRONOS B and their corresponding 95% confidence intervals The recruitment rate is defined as number recruited (consented) over total number of patients approached.
Pilot: Treatment Compliance to CHRONOS - A
时间窗: 12 months
To determine the treatment compliance of patients to receiving the treatment they have been allocated to through randomisation within CHRONOS A only and corresponding 95% confidence interval. CHRONOS B results provided in a separate table
Pilot: Treatment Compliance (CHRONOS-B)
时间窗: 12 months
To determine the treatment compliance of patients to receiving the treatment they have been allocated to through randomisation within CHRONOS B only and corresponding 95% confidence interval CHRONOS A results provided in a separate table
Drug Compliance to CHRONOS-B Only
时间窗: 12 months
To determine patients drug compliance to allocated IMP treatment within randomisation of CHRONOS-B Arm 4 and Arm 5 only as CHRONOS -B Arm 3 is non-IMP. CHRONOS Arm A is not included as both arms are non-IMP
Pilot: Randomisation Rate to CHRONOS A & CHRONOS B and Their Corresponding 95% Confidence Intervals
时间窗: 12 months
To estimate the randomisation rate to CHRONOS A \& CHRONOS B and their corresponding 95% confidence intervals The Randomisation rate is defined as number of randomised patients over total number of patients recruited (consented)
次要结局
未报告次要终点