High Dose Rate Brachytherapy, Interstitial Radiation, Prostate Cancer, Ultrasound-based Planning Compared to CT-based Planning
Conditions
Keywords
prostate cancer, interstitial radiation,, brachytherapy
Brief summary
High Dose Rate (HDR) temporary prostate brachytherapy offers a precise form of dose escalation for prostate cancer. Needles are placed, the position is confirmed and treatment is delivered. Previously High Dose Rate prostate brachytherapy was performed under TransRectal UltraSound (TRUS) guidance but planned with Computed Tomography (CT) imaging which introduced a source of error through needle displacement while transporting and repositioning patient. Recently Varian has introduced a one-step procedure where both implant and planning are based on UltraSound imaging and performed without patient repositioning. This planning system is approved by Health Canada and is commercially available. This study will use High Dose Rate brachytherapy to treat 20 men. Treatment will be planned with TransRectal UltraSound and validated using Computed Tomography imaging.
Detailed description
Twenty men with intermediate risk prostate cancer, suitable for the combination of external beam radiotherapy and High Dose Rate brachytherapy will be entered in this study. High Dose Rate brachytherapy will be performed using TransRectal UltraSound guidance and then planned using both cone-beam Computed Tomography and TransRectal UltraSound. Planning by Computed Tomography is to check the reliability and reproducibility of UltraSound imaging to correctly identify the needle positions. Correct needle localization is essential because this is the basis for determining source dwell positions, dose calculation and dose optimization.
Interventions
RADIATIONHDR prostate brachytherapy
HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a boost combined with external beam radiotherapy
Sponsors
British Columbia Cancer Agency
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must have histologically proven adenocarcinoma of the prostate. 2. Patients must have intermediate risk prostate cancer. (Clinical stage ≤ T2c, Gleason score = 7 and initial prostate specific antigen (iPSA) ≤ 20, or Gleason score ≤ 6 and iPSA \> 10 and ≤ 20. 3. Patients must be fit for general or spinal anaesthetic. 4. Patients must have an estimated life expectancy of at least 10 years. 5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2. 6. Patients must have no contraindications to interstitial prostate brachytherapy. 7. Patients on coumadin therapy must be able to stop therapy safely for at least 7 days.
Exclusion criteria
* Men not able to fully understand the trial and the informed consent document * Men suffering from claustrophobia and unable to have a Computed Tomography scan * Men not wishing to have a cone-beam Computed Tomography scan following the insertion of the High Dose Rate brachytherapy needles to verify the accuracy of the treatment plan * Men who cannot safely discontinue blood thinners for a few days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Needle Tip Identification on TransRectal UltraSound Compared to Computed Tomography | Treatment was planned and delivered based on ultrasound identification of needles and needle tips relative to prostate. All measurements and comparisons of measurements pertain to the day of the procedure. | Precise location of the tip of each needle in 3-dimensional space relative to the prostate determines the pattern of dose delivery. Inaccuracies in needle tip location may lead to differences detected between UltraSound(US)-based and Computed Tomography (CT)-based plans.The distance of the needle tip (as identified on either CT images or US images) protruding beyond the template was measured in mm. The template acted as a fixed reference point as it was locked into the stabilizer/stepper apparatus. The 2 protrusion readings for each needle tip were compared, the difference recorded in mm, and categorized as \< 1 mm, 1-2 mm, 2-3 mm and \> 3 mm. |
Countries
Canada
Participant flow
Recruitment details
20 patients were recruited from the target population of men with localized prostate cancer undergoing radical radiotherapy consisting of a combination of external beam radiation and 2 fractions of 10 Gray each of High Dose Rate brachytherapy
Participants by arm
| Arm | Count |
|---|---|
| Localized Prostate Cancer Patients had either intermediate risk or favorable high risk disease suitable for definitive radiotherapy. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Localized Prostate Cancer |
|---|---|
| Age, Continuous | 65 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment Canada | 20 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 20 |
| other Total, other adverse events | 2 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
Accuracy of Needle Tip Identification on TransRectal UltraSound Compared to Computed Tomography
Precise location of the tip of each needle in 3-dimensional space relative to the prostate determines the pattern of dose delivery. Inaccuracies in needle tip location may lead to differences detected between UltraSound(US)-based and Computed Tomography (CT)-based plans.The distance of the needle tip (as identified on either CT images or US images) protruding beyond the template was measured in mm. The template acted as a fixed reference point as it was locked into the stabilizer/stepper apparatus. The 2 protrusion readings for each needle tip were compared, the difference recorded in mm, and categorized as \< 1 mm, 1-2 mm, 2-3 mm and \> 3 mm.
Time frame: Treatment was planned and delivered based on ultrasound identification of needles and needle tips relative to prostate. All measurements and comparisons of measurements pertain to the day of the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Localized Prostate Cancer | Accuracy of Needle Tip Identification on TransRectal UltraSound Compared to Computed Tomography | 1.1 mm | Standard Deviation 0.1 |