Know Cancer

forgot password

High Dose Rate Prostate (HDR) Brachytherapy Dose Escalation to Dominant Intra-prostatic Nodule for Patients With Intermediate and High Risk Prostate Cancer

Phase 2
40 Years
80 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

High Dose Rate Prostate (HDR) Brachytherapy Dose Escalation to Dominant Intra-prostatic Nodule for Patients With Intermediate and High Risk Prostate Cancer

Methods: If a dominant nodule is visualized on DCE MRI, it will be contoured in 3D and the
images fused to the planning TRUS study that is done in preparation for brachytherapy (of
any type: seeds or HDR). The patient's treatment will consist of the standard combined
external beam (4600 cGray in 23 fractions) and HDR brachytherapy boost (2 fractions of 1000
cGray given on days 5 and 15 of the external beam course). During each HDR treatment the
plan will be manipulated such that the normally occurring high dose regions (125%, 150%) are
positioned at the site of the identified disease. Normally approximately 60% of the prostate
volume receives 125% of the dose and 30% receives 150%. By ensuring that the inherent
dosimetry favors treatment of the known cancer, no region of the prostate would be
"underdosed". HDR treatments are performed under general anesthesia as an out patient

Statistical Analysis: This is a feasibility study and the data reported will be descriptive
including the frequency with which the DIL can be visualized in this population, the DIL
volume compared to total prostate volume, and the isodose that can encompass the DIL without
violating dose constraints to adjacent organs (urethra and bladder). Toxicity will be
monitored and efficacy will be assessed by repeat DCE MRI at 12 months and biopsy at 30

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 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.

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of delivery of a higher than prescription dose to the dominant intra-prostatic nodule as defined on diffusion contrast-enhanced endo-rectal MRI, while respecting tolerance doses of adjacent normal organs.

Outcome Description:

Data to be collected are: i) ratio of volume of GTV to prostate volume ii) number of DIL's per prostate iii) isodose encompassing DIL without exceeding critical organ dose constraints (Urethral volume receiving 115%= 0, Dose to 1cc of rectal wall < 7 Gy)

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Matthew Schmid, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Physicst


Canada: Ethics Review Committee

Study ID:




Start Date:

May 2012

Completion Date:

December 2015

Related Keywords:

  • Prostate Cancer
  • prostate neoplasms
  • interstitial radiation
  • High dose rate prostate brachytherapy
  • dose escalation
  • Prostatic Neoplasms