Pilot Study of Focal Salvage HDR Prostate Brachytherapy

Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01583920

Sponsor: Sunnybrook Health Sciences Centre


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Biopsy-confirmed locally recurrent prostate adenocarcinoma > 30months after the completion of XRT, SBRT, LDR or HDR brachytherapy boost with XRT, or LDR or HDR brachytherapy as monotherapy by a stereotactic transperineal biopsy
  • Staging T2-weighted, DWI and DCE-MRI that demonstrates solitary recurrence confined to prostate, and correlates with stereotactic transperineal biopsy
  • Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases
  • American Urological Association Symptom Index Score (ie. IPSS) < 15
  • Baseline (post-XRT) serum PSA < 10 ng/mL
  • Prostate volume as measured by transrectal ultrasound (TRUS) < 50cc
  • ECOG performance status 0-1

Exclusion Criteria:

  • Any of the following prior therapies: transurethral resection of the prostate (TURP), radionuclide (permanent or temporary implantation) prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU (high-intensity focused ultrasound), bilateral orchiectomy, chemotherapy for prostatic carcinoma
  • Evidence of castrate resistance (defined as PSA > 3 ng/mL while testosterone is < 1.7 nmol/L). Patients could have been on combined androgen blockade with initial radiotherapy but are excluded if this was started due to PSA progression.

View trial on ClinicalTrials.gov

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