TROG 15.01: Efficacy of Kilovoltage Intrafraction Monitoring (KIM) in Stereotactic Prostate Adaptive Radiotherapy on clinical outcomes and toxicity in prostate cancer patients (SPARK)

The University of Sydney0 个研究点目标入组 49 人开始时间: 2015年4月14日最近更新: 2021年6月28日

适应症

试验速览

暂无简介。

•1. Histologically proven prostate adenocarcinoma
•2. Low or intermediate risk disease as defined by:
•- Low Risk: All of PSA<10 ng/mL, Gleason Grade 6 AND Stage T1 or T2a
•- Intermediate Risk: Any or all of PSA 10-20 ng/mL, Gleason Grade 7 OR Stage T2b-c
•- Absence of high risk features (PSA>20, T3-4, N1 or M1 disease, Gleason score 8-10)
•(PSA must be within 3 months prior to enrolment)
•3. ECOG Performance status 0-2
•4. Suitable for definitive external beam radiotherapy (IMRT or VMAT)
•5. Ability to have three gold fiducial markers placed in the prostate*
•6. Six month course of androgen deprivation therapy allowed at clinician discretion.
•7. Available for follow up for a minimum of 2 years (up to 3 years)
•*if on anticoagulants, must be approved for procedure

•1. Lymph node irradiation
•2. Any other systemic anti-prostate cancer therapy (i.e. non-ADT) both proven in the metastatic setting and investigational (e.g. docetaxel, enzalutamide)
•3. Artificial hip(s) (Unable to visualise markers through prosthesis)
•4. Prostate volume > 90 cm3 measured from the CT scan
•5. Patient lateral dimension >40cm as measured at the level of the prostate from the CT scan
•6. Suboptimal fiducial markers placement for treatment utilising KIM as assessed by a medical physicist by measuring marker positions from the CT scan
•7. Fiducial migration or fewer than 3 fiducials present in the CT scan

发起方