CTIS2024-510707-11-00进行中（未招募）1 期
Prostate-only, dose-escalated radiotherapy plus concomitant androgen deprivation therapy in primary localized, NCCN high risk and MMAI classifier low or intermediate-risk prostate cancer – a prospective, single-arm, phase II study - HypoPro
inac-Pet Scan Opco Limited0 个研究点目标入组 30 人开始时间: 2024年2月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- Male
入选标准
- •Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old), Prostate biopsy core with the highest ISUP grade available, High- or very hih-risk according to NCCNv4.2023 criteria, Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI)), Signed written informed consent for this study, Age >18 years, Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR, MMAI low-/intermediate-risk, ECOG Performance score 0 or 1, IPSS Score =15
排除标准
- •Prior radiotherapy to the prostate or pelvis, Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed, Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;, Prior radical prostatectomy, Known or persistent abuse of medication, drugs or alcohol, Patients expected to have severe set up problems (e.g. mental condition), Prior focal therapy approaches to the prostate, Evidence of pelvic nodal disease (cN+) in mpMRI and/or PSMA-PET/CT, Evidence of distant metastatic disease (cM+) in mpMRI and/or PSMA-PET/CT, Time gap between the beginning of any systemic therapy, ADT and conduction of PSMA-PET scans is >2 months, Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT, Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts, PSA >50 ng/ml prior to starting of systemic therapy, Expected patient survival <5 years, Contraindication to Goserelin, Contraindication to undergo a MRI scan, Contraindication to undergo HDR brachytherapy (brachytherapy not feasible due to large prostate volume, prostate anatomy, tumor in distant seminal vesicles and/or unfit for anaesthesia), Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization, Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia, Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival, Any other contraindication to external beam radiotherapy (EBRT) to the pelvis, Participation in any other interventional clinical trial within the last 30 days before the start of this trial
研究者
相似试验
已完成
2 期
A trial of prostate radiotherapy in conjunction with carbogen and nicotinamideMalignant neoplasm of prostateCancerProstate cancerISRCTN08912168East and North Hertfordshire Hospitals NHS Trust (UK)50
进行中（未招募）
1 期
Prostate Radiotherapy with Oxygen EnhancementMedDRA version: 14.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Prostate CancerEUCTR2010-021886-63-GBEast and North Hertfordshire NHS Trust50
招募中
3 期
Stereotactic body radiation therapy on Prostate with or without Androgen deprivation therapy, a phase III randomized controlled trial (SPA Trial)2024-520093-34-00Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia310
招募中
3 期
Prostate bed irradiation with alternative radio-oncological approachesDRKS00015231niversitätsklinikum HeidelbergAbteilung RadioOnkologie und Strahlentherapie897
招募中
2 期
Artificial Intelligence Driven Personalisation of Radiotherapy and Concomitant Androgen Deprivation Therapy for Prostate Cancer Patients (the HypoPro Trial)Prostate CancerNCT06772441German Oncology Center, Cyprus30