Status:
TERMINATED
Intraprostatic MAXimal Simultaneous Boost
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
NA
Brief Summary
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 organ...
Eligibility Criteria
Inclusion
- Patients must have histologically proven adenocarcinoma of the prostate.
- Registration must occur within 26 weeks of biopsy.
- History and physical examination (including digital rectal examination (DRE)) within 8 weeks prior to registration.
- 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)
- 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.
- Patients must have an estimated life expectancy of at least 10 years.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
- Patients must have no contraindications to high dose pelvic irradiation.
- Patients must not have received prior radiation therapy to the pelvis.
- Patients must have no history of inflammatory bowel disease.
- Patients must not have received prior hormonal therapy or chemotherapy.
- Patients must not have any hormonal therapy planned as part of the therapeutic intervention.
- Patients must have no contraindication to MRI scanning.
- Patients should not have an artificial hip
- Patients should not have a body mass index (BMI) of \> 32. Note: BMI = weight in kg ÷ (height in metres)2
Exclusion
- 1\. Subjects that do not meet inclusion criteria.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00798837
Start Date
December 1 2008
End Date
October 1 2016
Last Update
July 11 2018
Active Locations (1)
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1
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6