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ACTIVE NOT RECRUITING
NCT00951535
PHASE2

A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0 M0 Prostate Cancer. ICORG 08-17

Sponsor: Cancer Trials Ireland

View on ClinicalTrials.gov

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

OTHER

questionnaire administration

PROCEDURE

quality-of-life assessment

RADIATION

image-guided radiation therapy

RADIATION

intensity-modulated radiation therapy

RADIATION

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