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 : February 23, 2021
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).
|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).
Sub-Study 1 (Proteomic Analysis):
To use proteomic analysis of sequential blood and urine samples to detect changes in profiles that may predict outcome and identify prognostic biochemical markers of early disease progression and/ or toxicity. The unique molecular signatures may also allow the identification of targets for therapeutic intervention.
To undertake, where possible, other biochemical analyses including mRNA, miRNA and metabolite profiling.
Sub-Study 2 (Raman spectroscopic analysis):
To investigate a new approach to prediction of radiation response, based on biochemical fingerprinting
- 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, GI and erectile dysfunction 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|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2025|
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: 7-9 years median follow-up ]
- Overall survival and disease free survival rates [ Time Frame: 5-7 years follow-up ]
- Maximum dose escalation [ Time Frame: 9 years follow-up ]
- 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: 9 years follow-up ]
- Identify prognostic and biochemical markers of early disease progression (Sub-Study 1) [ Time Frame: 9 years follow-up ]To detect changes in profiles that may predict outcome and identify prognostic and biochemical markers of early disease progression in accordance with the primary and secondary objectives using Proteomic Analysis of sequential blood and urine samples.
- Develop a platform for endpoint prediction using Raman spectroscopy and machine learning (Sub-Study 2) [ Time Frame: 9 years follow-up ]Raman spectra will be recorded from both lymphocytes and sera to produce a library of spectral measurements in patients pre- and post-treatment. Established methodologies for the assessment of the patient radiosensitivity (G2 assay, DNA damage assays and gene expression profiling), will be used in parallel with advanced multivariate and machine learning methodologies to develop a platform for prediction of such endpoints using Raman spectra of the cellular and plasma fraction of the patient blood.
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|
|SLRON St Luke's Hospital|
|Dublin, Ireland, 6|
|SLRON St James's Hospital|
|SLRON, Beaumont Hospital|
|Principal Investigator:||John Gerard Armstrong, MD, MB, MRCPI||SLRON St Luke's Hospital|