Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Intraprostatic MAXimal Simultaneous Boost

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
James Morris, British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00798837
First received: November 24, 2008
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: Intraprostatic maximal simultaneous boost
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose-escalation Study Using a Maximal Simultaneous Intraprostatic Boost With RapidArc Intensity Modulated Radiotherapy in Intermediate Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Incidence of grade 2-4 gastrointestinal and genitourinary toxicity [ Time Frame: No time frame (post-treatment) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life (EPIC, IPSS and SHIM questionnaires) [ Time Frame: No time frame (post-treatment) ] [ Designated as safety issue: No ]
  • Percentage of CTV treated to boost dose [ Time Frame: Immediately post-treatment ] [ Designated as safety issue: No ]
  • Time-cost analysis compared to external-beam radiotherapy with brachytherapy boost [ Time Frame: No time frame ] [ Designated as safety issue: No ]
  • Accuracy of surrogate urethra compared to T2-MRI localization [ Time Frame: No time frame ] [ Designated as safety issue: No ]
  • Quantification of dose received by lesions identified by diffusion-weighted and dynamic contrast enhanced MRI [ Time Frame: No time frame ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2008
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IMAX

There is only one arm in this study.

Each patient will undergo a course of intensity modulated external beam radiation therapy (IMRT) using RapidArc for optimization and delivery.

Doses of radiotherapy are as follows:

  • The prescription dose will be 73.7 Gy in 28 fractions.
  • A simultaneous intraprostatic maximal simultaneous boost will be given to as much of the CTV as possible without contravening OAR dose constraints.
Radiation: Intraprostatic maximal simultaneous boost

Each patient will undergo a course of intensity modulated external beam radiation therapy (IMRT) using RapidArc for optimization and delivery.

Doses of radiotherapy are as follows:

  • The prescription dose will be 73.7 Gy in 28 fractions
  • A simultaneous intraprostatic boost will be given to as much of the CTV as possible without contravening OAR dose constraints.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798837

Locations
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: William J Morris, MD British Columbia Cancer Agency
  More Information

No publications provided

Responsible Party: James Morris, Dr. James Morris, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00798837     History of Changes
Other Study ID Numbers: IMAX
Study First Received: November 24, 2008
Last Updated: February 5, 2013
Health Authority: Canada: Health Canada

Keywords provided by British Columbia Cancer Agency:
prostate
cancer
IMRT
radiation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014