NCT07391982招募中不适用
Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in 2 Fractions
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Acute GU toxicity
研究概览
简要总结
The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer.
The main questions it aims to answer are:
- Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects?
- Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas?
Researchers will compare two treatment approaches:
- One group receives a uniform high dose to the entire prostate.
- The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas.
Participants will:
- Receive two sessions of MRI-guided radiotherapy using an MR-Linac.
- Complete questionnaires about urinary, bowel, and sexual health before and after treatment.
- Have follow-up visits to monitor side effects and PSA levels for up to 2 years.
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
- •Men aged ≥18 years
- •Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
- •Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3)
- •MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and <2.5cm in maximal dimension. MRI must be performed within 3 months of trial entry
- •The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported).
- •MRI stages mT1 and T2 or mT3a with ≤ 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018)
- •PSA <20 ng/ml prior to starting androgen deprivation therapy (ADT).
- •WHO Performance status 0-2
- •Ability of the participant to understand and the willingness to sign a written informed consent (IC) form.
- •Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
排除标准
- •Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- •IPSS Score > 19
- •High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area.
- •Prostate volume >90cc
- •Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
- •Hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
- •Previous pelvic radiotherapy
- •Patients needing >6 months of ADT due to disease parameters.
- •Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.
研究组 & 干预措施
Uniform dose SBRT
Other
干预措施: uniform dose radiotherapy (Radiation)
De-escalated dose SBRT
Other
干预措施: De-escalated dose radiotherapy (Radiation)
结局指标
主要结局
Acute GU toxicity
时间窗: within 13 weeks of starting radiotherapy
Physician-reported acute Grade 2 or higher CTCAE GU toxicity observed within 13 weeks of starting radiotherapy
次要结局
- Biochemical relapse-free survival(2 years)
- Dosimetry(During Radiotherapy treatment of 8 days)
- Late GI toxicity(1 and 2 years after radiotherapy treatment)
- Severity of erectile dysfunction experienced by patient(Before radiotherapy treatment, and at 6, 12 and 24 months after radiotherapy treatment)
- Acute GI toxicity(At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment)
- Late GU toxicity(1 and 2 years after radiotherapy treatment)
- Late sexual toxicity(1 and 2 years after radiotherapy treatment)
- Severity of urinary symptoms (GU) experienced by patient(Before radiotherapy treatment, after the last fraction, at 2, 4 and 12 weeks post-treatment, and at 6, 12 and 24 months after radiotherapy treatment)
- Health-related quality of life experienced by patient(Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy treatment.)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 FractionsNCT07343349Rigshospitalet, Denmark1,016
招募中
2 期
Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)Prostate CancerNCT07313241University of Texas Southwestern Medical Center68
招募中
3 期
Vascular Optimized Radiotherapy Tuned to Critical Structures for Erectile Function Using High-Precision X-Ray TreatmentProstate CancerNCT07293585Jonsson Comprehensive Cancer Center200
进行中（未招募）
1 期
Artificial Intelligence driven personalisation of radiotherapy and concomitant androgen deprivation therapy for prostate cancer patientsMedDRA version: 20.0Level: PTClassification code: 10060862Term: Prostate cancer Class: 100000004864Prostate cancerCTIS2024-510707-11-00inac-Pet Scan Opco Limited30
尚未招募
Unknown
IMProving the quality of life for rAdiation therapy prostate Cancer patienTs (IMPACT)Cancer - ProstateProstate cancerACTRN12624000106538South Western Sydney Local Health District60