A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0 M0 Prostate Cancer. ICORG 08-17
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.
Other: questionnaire administration
Procedure: quality-of-life assessment
Radiation: image-guided radiation therapy
Radiation: intensity-modulated radiation therapy
Radiation: radiation therapy treatment planning/simulation
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0M0 Prostate Cancer|
- Biochemical Failure Free survival [ Time Frame: 2017 ] [ Designated as safety issue: No ]
- Overall survival and disease free survival rates [ Time Frame: 2017 ] [ Designated as safety issue: No ]
- Maximum dose escalation [ Time Frame: 2017 ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 2017 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||September 2026|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Treatment will be delivered in 1.8 Gy fractions; dose escalation will be in 1.8 Gy increments from 75.6 Gy to a maximum 81 Gy.
|Other: questionnaire administration Procedure: quality-of-life assessment Radiation: image-guided radiation therapy Radiation: intensity-modulated radiation therapy Radiation: radiation therapy treatment planning/simulation|
To determine if dose escalated IMRT for high risk localised prostate cancer can provide PSA relapse free survival similar to that reported by Memorial Sloan Kettering (Alicikus et al 2011
- Overall survival and disease-free survival rates.
- To evaluate the significance of published prognostic/ stratification factors such as the UCSF-CAPRA score and assess their application to the data from this study.
- To achieve the maximum dose escalation (up to 81Gy). This will be assessed as the percentage of patients that receive each dose level for all categories (dose increments of 1.8 Gy from 75.6 Gy up to max 81 Gy).
- The incidence and severity of acute and late GU and GI toxicities will be described, and correlated with DVH parameters
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951535
|Cork University Hospital||Active, not recruiting|
|Saint Luke's Hospital||Recruiting|
|Dublin, Ireland, 6|
|Contact: John Gerard Armstrong, MD, MB, MRCPI +353 1 4065000|
|Contact: Contact Person 01-2936600|
|Sub-Investigator: Alina Mihai, Dr|
|SLRON, Beaumont Hospital||Recruiting|
|Contact: Contact Person 01-8093000|
|Sub-Investigator: Brian O'Neill, Dr|
|SLRON, St James's Hospital||Recruiting|
|Contact: Contact Person 01-4103000|
|Sub-Investigator: Pierre Thirion, Dr|
|Principal Investigator:||John Gerard Armstrong, MD, MB, MRCPI||Saint Luke's Hospital|