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Completed

NCT Number: NCT01605097

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Center for the Southern Interior

Kelowna, British Columbia, V1Y5L3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HDR interstitial brachytherapy

Radiation

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study title

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

Acronym: Dosepainting

Important dates

Study start
2012
Primary completion
2013
Study completion
2018
First posted
May 24, 2012
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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