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Partial Prostate Salvage High Dose Rate Brachytherapy (SalvageHDR)

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. Identifier: NCT03246802
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : July 1, 2021
Information provided by (Responsible Party):
Juanita Crook, British Columbia Cancer Agency

Brief Summary:
A dose-response relationship for radiation in the management of prostate cancer is well established. Local recurrence of prostate cancer after external beam radiotherapy occurs in at least 40% of patients treated because of inability to deliver sufficient dose through external beam techniques. These patients respond well to re-irradiation using brachytherapy with about 50% of selected patients remaining free of recurrence 5 years after salvage. Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows identification of the site of recurrence, permitting partial prostate salvage brachytherapy. There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose Rate.

Condition or disease Intervention/treatment Phase
Recurrent Prostate Cancer Radiation: HDR partial prostate brachytherapy Not Applicable

Detailed Description:
Appropriately selected patients with histologically documented recurrence 3 years or more after initial external beam radiotherapy will undergo mpMRI for identification of the site of recurrence. A planning transrectal ultrasound (TRUS) will be obtained for fusion with the mpMRI and transposition of the target volume (GTV=gross tumor volume). A margin of 4.5 cm will be added to the GTV to create a focal planning target volume (PTV). The margin may be cropped at the interface with critical organs. Two fractions of HDR brachytherapy will be delivered, each from a single implant, 2 weeks apart. Following treatment patients will be monitored for toxicity and quality of life using the Expanded Prostate cancer Index (EPIC) questionnaire as well as the International Prostate Symptom score. Efficacy will be evaluated by monitoring the Prostate Specific Antigen (PSA) and repeat mpMRI at 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: High Dose Rate brachytherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: HDR partial prostate brachytherapy
2 fractions of high dose rate prostate brachytherapy will be delivered to the site of recurrent disease as determined by mp-MRI
Radiation: HDR partial prostate brachytherapy
temporary radioactive implant

Primary Outcome Measures :
  1. Late adverse gastrointestinal or genitourinary events grade 3 or higher [ Time Frame: 3-60 months ]
    Common Terminology Criteria for Adverse Events (CTCAE V4.0)

Secondary Outcome Measures :
  1. Late Quality of Life [ Time Frame: 3-60 months ]
    Expanded Prostate Cancer Index (EPIC)

  2. Late lower urinary tract symptoms [ Time Frame: 3-60 months ]
    International Prostate Symptom Score

  3. Acute grade 3 or higher gastrointestinal or genitourinary adverse events [ Time Frame: 0-3 months ]
    Common Terminology Criteria for Adverse Events (CTCAE V4.0)

  4. Acute Quality of Life changes [ Time Frame: 0-3 months ]
    Expanded Prostate Cancer Index (EPIC)

  5. Acute lower urinary symptoms [ Time Frame: 0-3 months ]
    International Prostate Symptoms Score

  6. Biochemical disease free survival [ Time Frame: 60 months ]
    PSA < 0.4 ng/ml at 60 months

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >45 and Life expectancy >10 years
  • Previous External Beam Radiotherapy (EBRT) dose up to 78Gray/39 fractions, 81 Gray/45 fractions or 70 Gray/28 fractions
  • > 3 year interval since EBRT
  • No late toxicity from prior EBRT > grade 2
  • Rising PSA post EBRT > nadir + 2 ng/ml but < 10 ng/ml
  • PSA Doubling time > 6 months
  • Negative staging with CT scan of the abdomen/pelvis and bone scan
  • Able to undergo multiparametric MRI with endorectal coil
  • Radiographic evidence of dominant intraprostatic lesion (DIL) as only area of recurrence (i.e unifocal recurrence) and corresponding to site of original disease
  • Biopsy confirmation of DIL with pathology review by British Columbia Cancer Agency GenitoUrinary pathologist (TB)
  • Willing to provide informed consent
  • History and physical examination within 90 days of registration
  • ECOG performance status 0-1 prior to registration
  • IPSS < 16, or adequate voiding study (post void residual < 100cc and peak flow rate > 10 cc/second).
  • No prior trans urethral prostatic resection
  • Recurrence suitable for implant with HDR brachytherapy as assessed on ultrasound simulation (maximum PTV ideally < 65% of prostate volume)
  • No history of inflammatory bowel disease or previous rectal surgery
  • Suitable for procedure under anesthesia, spinal or general
  • INR <2.5 and platelet count >75 x 109/L
  • Androgen Deprivation Therapy may be initiated at the discretion of the treating oncologist

Exclusion Criteria:

  • Not compliant with criteria above
  • Unable to give informed consent

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 identifier (NCT number): NCT03246802

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Contact: Juanita Crook, MD 2507123958
Contact: Francois Bachand, MD 2507123900

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Canada, British Columbia
BCCA Center for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Juanita Crook, MD    250 712 3958   
Contact: Francois Bachand, MD    250 712 3900   
Principal Investigator: Juanita Crook, MD         
Sub-Investigator: Deidre Batchelar, PhD         
Sub-Investigator: Michelle Hilts, PhD         
Sub-Investigator: Marie-Pierre Milette, PhD         
Sub-Investigator: Ross Halperin, MD         
Sub-Investigator: David Petrik, MD         
Sub-Investigator: David Kim, MD         
Sub-Investigator: Brenda Farnquist, MD         
Sub-Investigator: Terry Bainbridge, MD         
Sponsors and Collaborators
British Columbia Cancer Agency
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Study Director: Mira Keyes, MD BCCA

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Responsible Party: Juanita Crook, Professor of Radiation Oncology, British Columbia Cancer Agency Identifier: NCT03246802    
Other Study ID Numbers: H17-01641
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: July 1, 2021
Last Verified: June 2021
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 Juanita Crook, British Columbia Cancer Agency:
recurrent prostate cancer
salvage HDR brachytherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases