High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy

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High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy

Condition: Recurrent Prostate Cancer

Intervention:

  • Radiation: HDR partial prostate brachytherapy

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03246802

Sponsor: British Columbia Cancer Agency

Primary Outcome Measures:

  • Measure: Late adverse gastrointestinal or genitourinary events grade 3 or higher
  • Time Frame: 3-60 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Late Quality of Life
  • Time Frame: 3-60 months
  • Safety Issue:
  • Measure: Late lower urinary tract symptoms
  • Time Frame: 3-60 months
  • Safety Issue:
  • Measure: Acute grade 3 or higher gastrointestinal or genitourinary adverse events
  • Time Frame: 0-3 months
  • Safety Issue:
  • Measure: Acute Quality of Life changes
  • Time Frame: 0-3 months
  • Safety Issue:
  • Measure: Acute lower urinary symptoms
  • Time Frame: 0-3 months
  • Safety Issue:
  • Measure: Biochemical disease free survival
  • Time Frame: 60 months
  • Safety Issue:

Estimated Enrollment: 15

Study Start Date: January 1, 2018

Eligibility:

  • Age: minimum 45 Years maximum 80 Years
  • Gender: Male

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

Contact:

  • Juanita Crook, MD
  • 2507123958

Location:

  • BCCA Center for the Southern Interior
  • Kelowna British Columbia V1Y 5L3 Canada

View trial on ClinicalTrials.gov

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