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Trial record 11 of 11 for:    juanita crook
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LDR vs. HDR Brachytherapy for Prostate Cancer (LDR/HDRmono)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03426748
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : April 14, 2023
Sponsor:
Collaborator:
BC Cancer Foundation
Information provided by (Responsible Party):
British Columbia Cancer Agency

Study Description
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Brief Summary:
H17-02904 is a randomized comparison of low dose rate vs. high dose rate prostate brachytherapy for favorable and intermediate risk prostate cancer suitable for brachytherapy as monotherapy. This is a continuation with expanded accrual of the randomized Pilot study H15-02103

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Low dose rate prostate brachytherapy Radiation: High dose rate prostate brachytherapy Not Applicable

Detailed Description:
Men suitable for prostate brachytherapy as monotherapy will undergo multiparametric Magnetic Resonance Imaging for staging and identification of a dominant lesion and will be randomly selected for either a single low dose rate permanent seed implant or 2 fractions of high dose rate brachytherapy. Using image registration techniques, dominant lesions will be biopsied under anesthesia at the start of the brachytherapy procedure. Biopsies will reviewed for tumor Gleason score and sent for Cell Cycle Progression testing (Prolaris). Patients receiving high dose rate brachytherapy will also have biopsies between the 2 fractions to assess tumor changes induced from the first fraction. Post implant quality assurance will determine the dose to the dominant lesions and compare these between the 2 types of brachytherapy. Post implant symptoms will be tracked for severity and time course.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Low Dose Rate Compared to High Dose Rate Prostate Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : August 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Low dose rate brachytherapy
Device: Radiation. Low dose rate prostate brachytherapy is delivered under anesthesia 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: permanent seed implant
Experimental: High dose rate brachytherapy

Device: Radiation. High dose rate prostate brachytherapy is delivered in 2 procedures, 2 weeks apart, also under anesthesia, 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


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

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

  6. Cell cycle progression score [ Time Frame: 1 month to 10 years ]
    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.

  7. Tumor oxygenation and cell cycle distribution [ Time Frame: 1 month to 10 years. ]
    For patients receiving 2 fractions of high dose rate brachytherapy, biopsy between the 2 fractions will assess radiosensitivity by evaluating changes in oxygenation and cell cycle distribution between the 2 fractions, for ultimate correlation with efficacy


Eligibility Criteria
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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:

Favorable risk and low-tier intermediate-risk prostate cancer with estimated life expectancy of at least 10 years.

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

  • 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 tumor 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
Contacts and Locations
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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): NCT03426748


Contacts
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Contact: Juanita M Crook, MD 250 712 3958 jcrook@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   
Sub-Investigator: Deidre Batchelar, PhD         
Sub-Investigator: Cynthia Araujo, PhD         
Sub-Investigator: David Kim, MD         
Sub-Investigator: David Petrik, MD         
Sub-Investigator: Michelle Hilts, PhD         
Sub-Investigator: Ross Halperin, MD         
Sub-Investigator: Moore Jocelyn, MD         
Sub-Investigator: Koulis Theodora, MD         
Principal Investigator: Halperin Ross, MD         
Sponsors and Collaborators
British Columbia Cancer Agency
BC Cancer Foundation
Investigators
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Study Director: Ross Halperin, MD British Columbia Cancer Agency Program Director
  Study Documents (Full-Text)

Documents provided by British Columbia Cancer Agency:
Study Protocol and Statistical Analysis Plan  [PDF] December 7, 2017

More Information
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Publications:

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Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT03426748    
Other Study ID Numbers: H17-02904
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: April 14, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by British Columbia Cancer Agency:
Brachytherapy
Quality of life
High dose rate vs. low dose rate
Intermediate risk group
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases