High Dose Rate Prostate Brachytherapy: Dose Escalation to Dominant Intra-prostatic Nodule (NCT01605097) | Clinical Trial Compass
CompletedNot Applicable
High Dose Rate Prostate Brachytherapy: Dose Escalation to Dominant Intra-prostatic Nodule
Canada26 participantsStarted 2012-05
Plain-language summary
This study will investigate the feasibility of using technology of ultrasound guided HDR brachytherapy to focally increase dose to regions within the prostate that are heavily infiltrated with cancer. Such regions, referred to as dominant intraprostatic lesions (DIL) can be visualized using diffusion contrast enhanced MRI employing an endo-rectal coil. The magnetic resonance (MR) images can be fused with the planning transrectal ultrasound (TRUS) prior to the brachytherapy procedure to design a dose distribution that will encompass the malignant volume with higher than the prescription dose. By its nature, brachytherapy has subvolumes that receive (for example)125% of the prescription dose or 150% of the prescription dose. With TRUS-guided and TRUS-planned HDR these areas can be manipulated to coincide with the DIL. The limit of dose escalation has been reached at whole prostate external beam doses of 81-86 Gy and still failure rates for intermediate and high risk disease are unacceptable. There is much interest in focal dose escalation and TRUS-guided HDR brachytherapy is perfectly suited to achieving this.
Who can participate
Age range
40 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* histologically proven adenocarcinoma of the prostate
* intermediate or high risk prostate cancer
* Intermediate risk prostate cancer patients must have:
* Clinical stage ≤ T2c,
* Gleason score = 7 and initial prostate specific antigen (iPSA) ≤ 20, or
* Gleason score ≤ 6 and iPSA \> 10 and ≤ 20.
* High risk patients may have
* Clinical stage T3
* Gleason score 8-10
* PSA \> 20 ng/ml
* fit for general anesthetic.
* unilateral disease with either a palpable nodule or a cluster of positive biopsies from a single region suggesting the presence of dominant nodule.
* estimated life expectancy of at least 10 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
* no contraindications to interstitial prostate brachytherapy.
* if on coumadin therapy must be able to stop safely for 7 days.
* must not have any contraindications to MRI
Exclusion Criteria:
* Does not meet staging criteria for intermediate or high risk prostate cancer
* Does not have a localized high volume of intraprostatic disease
* unfit for general anesthetic
* MRI contraindicated
* unable to stop blood thinners
* Life expectancy \< 10 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.