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Prostate CancerDosepaintingNCT01605097

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

A study testing HDR interstitial brachytherapy in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
HDR interstitial brachytherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteCanada
Study dates
May 2012to Jul 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Cancer Center for the Southern Interior

    Kelowna, British Columbia, V1Y5L3

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Prostate Cancer
Being tested
HDR interstitial brachytherapy
Keywords
prostate neoplasms, interstitial radiation, High dose rate prostate brachytherapy, dose escalation
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HDR interstitial brachytherapyRadiation

    Also called Planning soft ware Varian Medical Systems Vitesse III

    2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy

Study groups in NCT01605097
Study groupRoleWhat they receive
HDR interstitial brachytherapyExperimentalHDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion
Receives: Radiation: HDR interstitial brachytherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Mean Dose to 90% of DIL Volume

    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.

    Measured: 12 months

Secondary outcomes (2)

  1. Acute Toxicity

    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.

    Measured: 24 months

  2. Prostate Specific Antigen(PSA) Response at 5-years

    Efficacy assessed by biochemical PSA response reported at median 5 year follow up.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionJul 2013
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01605097
Sponsor's protocol ID
H12-00557
Acronym
Dosepainting
Status last verified
Aug 2017
First submitted
22 May 2012
Last updated
21 Jul 2021
Data monitoring committee
No
Individual data sharing
No

Publications

  • Groenendaal G, van den Berg CA, Korporaal JG, Philippens ME, Luijten PR, van Vulpen M, van der Heide UA. Simultaneous MRI diffusion and perfusion imaging for tumor delineation in prostate cancer patients. Radiother Oncol. 2010 May;95(2):185-90. doi: 10.1016/j.radonc.2010.02.014. Epub 2010 Mar 16.

    PubMed 20231041

  • Kim Y, Hsu IC, Lessard E, Kurhanewicz J, Noworolski SM, Pouliot J. Class solution in inverse planned HDR prostate brachytherapy for dose escalation of DIL defined by combined MRI/MRSI. Radiother Oncol. 2008 Jul;88(1):148-55. doi: 10.1016/j.radonc.2007.11.024. Epub 2008 Feb 20.

    PubMed 18083260

  • Pouliot J, Kim Y, Lessard E, Hsu IC, Vigneron DB, Kurhanewicz J. Inverse planning for HDR prostate brachytherapy used to boost dominant intraprostatic lesions defined by magnetic resonance spectroscopy imaging. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):1196-207. doi: 10.1016/j.ijrobp.2004.02.055.

    PubMed 15234056

  • De Bari B, Daidone A, Alongi F. Is high dose rate brachytherapy reliable and effective treatment for prostate cancer patients? A review of the literature. Crit Rev Oncol Hematol. 2015 Jun;94(3):360-70. doi: 10.1016/j.critrevonc.2015.02.003. Epub 2015 Feb 17.

    PubMed 25819287

Questions about this trial

What is this clinical trial studying?

A study testing HDR interstitial brachytherapy in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Mean Dose to 90% of DIL Volume (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01605097, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.

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