A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0 M0 Prostate Cancer. ICORG 08-17
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|ClinicalTrials.gov Identifier: NCT00951535|
Recruitment Status : Active, not recruiting
First Posted : August 4, 2009
Last Update Posted : January 10, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: questionnaire administration Procedure: quality-of-life assessment Radiation: image-guided radiation therapy Radiation: intensity-modulated radiation therapy Radiation: radiation therapy treatment planning/simulation||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||251 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0M0 Prostate Cancer|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||September 2026|
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
- Biochemical Failure Free survival [ Time Frame: 2017 ]
- Overall survival and disease free survival rates [ Time Frame: 2017 ]
- Maximum dose escalation [ Time Frame: 2017 ]
- The incidence and severity of Genito-urinary (GU), Gastro-intestinal (GI) and erectile dysfunction (ED) toxicities (graded by NCI CTCAE Version 3.0) will be analysed and correlated with dose volume histogram (DVH) parameters. [ Time Frame: 2017 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951535
|Cork University Hospital|
|Saint Luke's Hospital|
|Dublin, Ireland, 6|
|SLRON, Beaumont Hospital|
|SLRON, St James's Hospital|
|Principal Investigator:||John Gerard Armstrong, MD, MB, MRCPI||Saint Luke's Hospital|