Clinical trial NCT01248741: CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse
Official title: High Dose Rate (HDR)Prostate Brachytherapy With Vitesse tm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Interstitial Radiation
High Dose Rate Brachytherapy
Ultrasound-based Planning Compared to CT-based Planning
Keywords: prostate cancer
interstitial radiation,
brachytherapy
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 20
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of Needle Tip Identification on TransRectal UltraSound Compared to Computed Tomography
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: BCCA Center for the Southern Interior
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency Dept of Radiation Physics
name: Matthew Schmid, MSc
role: STUDY_DIRECTOR
References: