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A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0 M0 Prostate Cancer. ICORG 08-17
Sponsor: Cancer Trials Ireland
Summary
This is a prospective, phase II non-randomised controlled clinical study. Dose escalation will be implemented using 1.8 Gy increments from baseline 75.6 Gy. Patients' RT prescription may be escalated up to max 81 Gy once dose volume constraints are adhered to. All patients will be treated using the participating institution's standard rectal preparation protocol, bladder-filling protocol and appropriate immobilisation device(s). Cone beam CT on-treatment imaging is recommended for this study. However, the use of individual institutional imaging equipment and techniques is permitted. Acute GU/GI toxicities will be assessed weekly during treatment. GU/GI toxicities will also be assessed 2 months post RT, 8 months post RT and 6 monthly thereafter to year nine and in line with the participating institution's standard routine follow-up (FU) thereafter. Translational sub-studies (optional), only apply to patients who are consented prior to commencement of hormone therapy at centres participating in the translational sub-study. Patients at centres participating in the translational sub-studies will be given the option of participating in sub-study 1 (Proteomic Analysis), sub-study 2 (Raman spectroscopic analysis), or both (sample collection will not be mandatory).
Official title: A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0M0 Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
251
Start Date
2009-07-20
Completion Date
2026-06
Last Updated
2026-04-17
Healthy Volunteers
No
Conditions
Interventions
questionnaire administration
quality-of-life assessment
image-guided radiation therapy
intensity-modulated radiation therapy
radiation therapy treatment planning/simulation
Locations (5)
Cork University Hospital
Cork, Ireland
SLRON St Luke's Hospital
Dublin, Ireland
Beacon Hospital
Dublin, Ireland
SLRON St James's Hospital
Dublin, Ireland
SLRON, Beaumont Hospital
Dublin, Ireland