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

NCT01605097 | Completed Results

• 1 other identifier: H12-00557
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

prostate neoplasms; interstitial radiation; High dose rate prostate brachytherapy; dose escalation

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (2)

• Acute Toxicity

  24 months

• Prostate Specific Antigen(PSA) Response at 5-years

  5 years

Study Arms (1)

HDR interstitial brachytherapy

EXPERIMENTAL

HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion

Radiation: HDR interstitial brachytherapy

Interventions

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

Also known as: Planning soft ware Varian Medical Systems Vitesse III

HDR interstitial brachytherapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

Cancer Center for the Southern Interior

Kelowna, British Columbia, V1Y5L3, Canada

Location

Related Publications (4)

• 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.

  PMID: 20231041 BACKGROUND

• 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.

  PMID: 18083260 BACKGROUND

• 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.

  PMID: 15234056 BACKGROUND

• 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.

  PMID: 25819287 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr Juanita Crook
• Organization: BC Cancer

jcrook@bccancer.bc.ca

250 712 3958

Study Officials

• Matthew Schmid, MSc

  Medical Physicst

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: May 24, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2018
• Last Updated: July 21, 2021
• Results First Posted: July 16, 2021

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)