Clinical trial NCT00798837: Intraprostatic MAXimal Simultaneous Boost
Official title: A Dose-escalation Study Using a Maximal Simultaneous Intraprostatic Boost With RapidArc Intensity Modulated Radiotherapy in Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate
cancer
IMRT
radiation
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2008-11-26
Enrollment: 10
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility 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.

Primary outcomes:
measure: Incidence of grade 2-4 gastrointestinal and genitourinary toxicity
timeFrame: No time frame (post-treatment)
Secondary outcomes:
measure: Quality of life (EPIC, IPSS and SHIM questionnaires)
timeFrame: Post-treatment; every 6 mos until 5 years - then annual
measure: Percentage of CTV treated to boost dose
timeFrame: Immediately post-treatment
measure: Time-cost analysis compared to external-beam radiotherapy with brachytherapy boost
timeFrame: No time frame
measure: Accuracy of surrogate urethra compared to T2-MRI localization
timeFrame: No time frame
measure: Quantification of dose received by lesions identified by diffusion-weighted and dynamic contrast enhanced MRI
timeFrame: No time frame
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Centre
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: William J Morris, MD
role: PRINCIPAL_INVESTIGATOR
References: