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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 : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Tracking Information
First Submitted Date  ICMJE August 1, 2009
First Posted Date  ICMJE August 4, 2009
Last Update Posted Date July 24, 2018
Study Start Date  ICMJE June 2008
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2012)
Biochemical Failure Free survival [ Time Frame: 2017 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2009)
Rate of successful reproducibility of clinical target volume 3D position
Change History Complete list of historical versions of study NCT00951535 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2012)
  • Overall survival and disease free survival rates [ Time Frame: 2017 ]
  • Maximum dose escalation [ Time Frame: 2017 ]
  • Toxicity [ Time Frame: 2017 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2009)
  • Freedom from biochemical failure or recurrent disease
  • Maximum dose escalation
  • Establishment of set-up errors for supine vs prone patients/margins
  • Correlation of acute and late genitourinary and gastrointestinal toxicity with dose volume histograms and relevance of applied dose-volume constraints
  • Applied dose-volume constraints
  • Correlation of biochemical control with average rectal distension
  • Toxicity as assessed by NCI CTC acute toxicity criteria version 3.0
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0 M0 Prostate Cancer. ICORG 08-17
Official Title  ICMJE A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0M0 Prostate Cancer
Brief 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.

Detailed Description

Primary Objective:

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

Secondary Objectives:

  • 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  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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 Arms Arm A
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.
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 5, 2016)
251
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2009)
180
Estimated Study Completion Date September 2026
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients undergoing a radical course of RT for high-risk disease (defined according to the National Comprehensive Cancer Network Practice Guidelines in Oncology v.1 as one or more of the NCCN high risk criteria > or equal to T3, > or equal to Gleason 8, PSA > 20ng/ml)
  2. Only patients requiring neo-adjuvant / adjuvant hormonal therapy will be included in this study
  3. Absence of distant metastases as demonstrated by history and physical examination, FBC, screening profile including liver function tests, PSA and bone scan
  4. All patients must have an MRI/CT of the prostate and pelvis to investigate the nodal status and precise T-stage. This MRI/CT scan must be performed prior to commencement of hormonal therapy. Suspicious nodes need to be histologically proven to be benign before the patient can be included in the study). M0 on staging.
  5. No previous surgery for urinary conditions except TURP or TRUS
  6. KPS > or equal to 60
  7. Age >18 years
  8. Provision of written informed consent in line with ICH-GCP guidelines

Exclusion Criteria:

  1. Previous RT to the pelvic region
  2. The patient has nodal involvement or it is decided to electively treat pelvic lymph nodes
  3. The patient has had a bilateral orchidectomy
  4. The patient has previously received a full course of hormonal treatment for his prostate cancer
  5. The patient has or has had other malignancies within the last 5 years (non-melanoma skin cancer is permitted)
  6. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research/ medical team that the patient may not be able to comply with the protocol
  7. Patients who have had a prostatectomy
  8. The presence of hip prostheses
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00951535
Other Study ID Numbers  ICMJE 08-17 ICORG
ICORG 08-17
EU-
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cancer Trials Ireland
Study Sponsor  ICMJE Cancer Trials Ireland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Gerard Armstrong, MD, MB, MRCPI Saint Luke's Hospital
PRS Account Cancer Trials Ireland
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP