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Intraprostatic MAXimal Simultaneous Boost
This study is currently recruiting participants.
Study NCT00798837   Information provided by British Columbia Cancer Agency
First Received: November 24, 2008   Last Updated: October 14, 2009   History of Changes

November 24, 2008
October 14, 2009
December 2008
October 2016   (final data collection date for primary outcome measure)
Incidence of grade 2-4 gastrointestinal and genitourinary toxicity [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00798837 on ClinicalTrials.gov Archive Site
  • Quality of life (EPIC, IPSS and SHIM questionnaires) [ Designated as safety issue: No ]
  • Percentage of CTV treated to boost dose [ Designated as safety issue: No ]
  • Time-cost analysis compared to external-beam radiotherapy with brachytherapy boost [ Designated as safety issue: No ]
  • Accuracy of surrogate urethra compared to T2-MRI localization [ Designated as safety issue: No ]
  • Quantification of dose received by lesions identified by diffusion-weighted and dynamic contrast enhanced MRI [ Designated as safety issue: No ]
Same as current
 
Intraprostatic MAXimal Simultaneous Boost
A Dose-escalation Study Using a Maximal Simultaneous Intraprostatic Boost With RapidArc Intensity Modulated Radiotherapy in Intermediate Risk Prostate Cancer

This trial uses a type of radiotherapy called intensity modulated radiotherapy (IMRT), which is able to deliver the radiation to the prostate while delivering less dose to the surrounding normal organs compared with standard 3D conformal radiotherapy presently used at the BCCA. This trial will use RapidArc IMRT, which is a new way of delivering IMRT, where the radiation dose is delivered in a single rotation of the radiotherapy machine around the patient. This new method of delivering IMRT has been shown to be at least as good as conventional IMRT at delivering the dose, and takes less time to do so.

The aim of this study is to deliver a higher radiation dose to the prostate gland than the standard treatment while not increasing dose to the normal organs. In this way, it is hoped that the likelihood of the cancer coming back will be reduced without causing an increase in side-effects.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Prostate Cancer
Radiation: Intraprostatic maximal simultaneous boost
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
30
October 2016
October 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients must have histologically proven adenocarcinoma of the prostate.
  2. Registration must occur within 26 weeks of biopsy.
  3. History and physical examination (including digital rectal examination (DRE)) within 8 weeks prior to registration.
  4. Patients must have intermediate risk prostate cancer, as defined by:

    • PSA ≤ 20 ng/ml,
    • Gleason ≤ 7,
    • Stage ≤ T2c, and
    • Do not meet criteria for low-risk prostate cancer (Low-risk = All of: PSA ≤ 10 + Gleason ≤ 6 + stage ≤ T2b)
  5. Patients must have the following blood tests within two weeks of registration:

    • Prostate specific antigen (PSA), testosterone (TTT), complete blood count (CBC), electrolytes, creatinine.
    • Patients with values for one or more of these tests (not including PSA) that fall outside the normal range will need to be reviewed by the oncologist to determine their eligibility for this study.
  6. Patients must have an estimated life expectancy of at least 10 years.
  7. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
  8. Patients must have no contraindications to high dose pelvic irradiation.
  9. Patients must not have received prior radiation therapy to the pelvis.
  10. Patients must have no history of inflammatory bowel disease.
  11. Patients must not have received prior hormonal therapy or chemotherapy.
  12. Patients must not have any hormonal therapy planned as part of the therapeutic intervention.
  13. Patients must have no contraindication to MRI scanning.
  14. Patients should not have an artificial hip
  15. Patients should not have a body mass index (BMI) of > 32. Note: BMI = weight in kg ÷ (height in metres)2

Exclusion Criteria:

1. Subjects that do not meet inclusion criteria.

Male
 
No
 
Canada
 
NCT00798837
William James Morris/Radiation Oncologist, British Columbia Cancer Agency
IMAX
British Columbia Cancer Agency
 
Principal Investigator: William J Morris, MD British Columbia Cancer Agency
British Columbia Cancer Agency
October 2009

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