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Comparison of HDR vs. LDR Brachytherapy as Monotherapy for Intermediate Risk Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02692105
Recruitment Status : Recruiting
First Posted : February 25, 2016
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Juanita Crook, British Columbia Cancer Agency

Brief Summary:
This study will offer men with intermediate risk prostate cancer who are suitable for, and interested in, prostate brachytherapy, the opportunity to be randomized between low dose rate (LDR) brachytherapy using permanent implantation of radioactive seeds (the current standard of care in BC) and high dose rate (HDR) or temporary brachytherapy which is also available as a standard of care in BC but only when used as a boost in addition with external beam radiotherapy. In addition, men will be offered the opportunity for testing the aggressiveness of their cancer using Cell Cycle Progression Gene Profile.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Low dose rate prostate brachytherapy Radiation: High Dose Rate prostate brachytherapy Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Pilot Study of Low Dose Rate Compared to High Dose Rate Prostate Brachytherapy for Favourable Risk and Low Tier Intermediate Risk Prostate Cancer
Actual Study Start Date : May 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Low dose rate brachytherapy
Device: Radiation Low dose rate prostate brachytherapy is delivered under anaesthesia in a single 1.5-2 hour procedure as an out-patient. The men return 4 weeks later for detailed imaging to assess implant quality.
Radiation: Low dose rate prostate brachytherapy
Permanent implantation of radioactive Iodine-125 seeds under anesthesia with ultrasound guidance
Other Name: LDR brachytherapy, seed brachytherapy

Experimental: High dose rate brachytherapy

Device: Radiation High dose rate prostate brachytherapy is delivered in 2 procedures, 2 weeks apart, also under anaesthesia, but no follow-up imaging visit is required.

HDR brachytherapy is also accomplished as an out-patient.

Radiation: High Dose Rate prostate brachytherapy
Temporary implantation of radioactive material into the prostate in the form of a stepping source of Iridium 192 that travels through 16-18 needles or catheters strategically placed through the prostate
Other Name: HDR brachytherapy




Primary Outcome Measures :
  1. The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy. [ Time Frame: 0-36 months ]
    The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed.


Secondary Outcome Measures :
  1. Quality of Life in the bowel and sexual domains [ Time Frame: 0-36 months ]
    The EPIC score in the bowel and sexual domains will be evaluated at baseline, 1, 3, 6, 12, 24 and 36 months

  2. Time to return to baseline +/- 3 points for the International Prostate Symptom Score [ Time Frame: 0-36 months ]
    The IPS Score will be assessed at baseline, 1, 3, 6, 12, 24 and 36 months

  3. Acute and long term toxicity [ Time Frame: 0-10 years ]
    Acute and long-term toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE V4) at each follow up time point

  4. TRUS- MRI fusion [ Time Frame: baseline ]
    TRUS- MRI fusion will be developed within our planning software to facilitate treatment planning

  5. Biochemical Outcome [ Time Frame: 5-10 years ]
    PSA will be recorded every 6 months to 5 years and then annually to 10 years

  6. Histologic Outcome [ Time Frame: 3 years ]
    Prostate re-biopsy will be performed at 36 months to assess the local efficacy of treatment

  7. Cell cycle progression score [ Time Frame: one month ]
    For those patients consenting to targeted biopsies under anesthesia at the start of their brachytherapy procedure (separate optional consent) MRI-TRUS fusion accuracy will be verified by targeted biopsies and Biopsy material will be sent for genetic testing to determine Cell cycle Progression scores for both arms of the trial to ultimately correlate with outcome.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical stage T1c-T2b, PSA < 20, Gleason < 8
  • ECOG 0-1
  • Low tier intermediate-risk prostate cancer is defined by;

    o a single NCCN intermediate risk factor (either Gleason 7(3+4) and PSA < 10 ng/ml OR Gleason 6 and PSA 10-20 ng/ml)

  • Extensive favorable-risk disease is defined as:

    • clinical stage T1c-T2a
    • PSA < 10
    • Gleason 6
    • ≥ 50% of biopsy cores containing cancer
    • PSA density > 0.2 ng/cc
  • Selected intermediate risk patients not defined above

    • - T1c/T2a
    • - PSA < 10
    • -Gleason 4+3
    • -< 33% of cores involved
    • -Max tumour length in any core 10 mm
  • No androgen deprivation therapy (ADT)
  • Prostate volume by TRUS ≤ 60 cc.
  • Not eligible for, or accepting of, active surveillance according to NCCN guidelines.
  • Signed study specific informed consent.

Exclusion Criteria:

  • Prior radical surgery for carcinoma of the prostate,
  • Prior pelvic radiation
  • Prior chemotherapy for prostate cancer,
  • Prior TURP or cryosurgery of the prostate
  • Claustrophobic or unable to undergo MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692105


Contacts
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Contact: Juanita M Crook, MD 250 712-3958 jcrook@bccancer.bc.ca
Contact: Francois Bachand, MD 250 712 3958 fbachand@bccancer.bc.ca

Locations
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Canada, British Columbia
British Columbia Cancer Agency Center for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y5L3
Contact: Juanita Crook, MD    250 712 3958    jcrook@bccancer.bc.ca   
Contact: Francois Bachand, MD    250 712 3958    fbachand@bccancer.bc.ca   
Sub-Investigator: Matt Schmidt, MSc         
Sub-Investigator: Deidre Batchelar, PhD         
Sub-Investigator: Cynthia Araujo, PhD         
Sub-Investigator: David Kim, MD         
Sub-Investigator: David Petrik, MD         
Sub-Investigator: Marie-Pierre Millette, PhD         
Sub-Investigator: Michelle Hilts, PhD         
Sub-Investigator: Brenda Farnquist, MD         
Sub-Investigator: Terry Bainbridge, MD         
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
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Study Director: Ross Halperin, MD British Columbia Cancer Agency Program Director

Publications:
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Responsible Party: Juanita Crook, Professor of Radiation Oncology, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT02692105     History of Changes
Other Study ID Numbers: H15-02103
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Juanita Crook, British Columbia Cancer Agency:
prostate adenocarcinoma
intermediate risk group
brachytherapy
High Dose Rate vs Low Dose Rate
Quality of Life

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases