High Dose Rate Prostate Brachytherapy: Dose Escalation to Dominant Intra-prostatic Nodule (Dosepainting)

July 19, 2021 updated by: British Columbia Cancer Agency

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods: If a dominant nodule is visualized on dynamic contrast enhanced (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 centiGray (cGy) in 23 fractions) and HDR brachytherapy boost (2 fractions of 1000 cGy 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 procedure.

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 months.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y5L3
        • Cancer Center for the Southern Interior

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HDR interstitial brachytherapy
HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion
Radiation: HDR interstitial brachytherapy
2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy
Other Names:
  • Planning soft ware Varian Medical Systems Vitesse III

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Mean Dose to 90% of DIL Volume
Time Frame: 12 months
Feasibility of dose escalation to a minimum dose of 125% of prescription to 90% of the dominant intra-porstatic lesion (DIL) volume as defined on multiparametric endo-rectal magnetic resonance imaging (mpMRI) without exceeding critical organ dose constraints (Urethral volume receiving 115%= 0, Dose to 1cc of rectal wall < 7 Gy). 2 Fractions were performed and the mean dose to 90% of DIL volume was averaged.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Toxicity
Time Frame: 24 months
Time to normalize International Prostate Symptom Score (months). Score range 0-35 with 35 being worst outcome. Normalization refers to a return to baseline urinary function prior to treatment.
24 months
Prostate Specific Antigen(PSA) Response at 5-years
Time Frame: 5 years
Efficacy assessed by biochemical PSA response reported at median 5 year follow up.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Investigators

  • Principal Investigator: Matthew Schmid, MSc, Medical Physicst

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

May 22, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimate)

May 24, 2012

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H12-00557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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