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Pilot Study of Focal Salvage HDR Prostate Brachytherapy

Phase 1
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Pilot Study of Focal Salvage HDR Prostate Brachytherapy

Inclusion Criteria:

- Biopsy confirmed locally recurrent prostate adenocarcinoma > 30months after the
completion of radiotherapy 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

- Low or intermediate risk prostate cancer at initial diagnosis that is defined as
stages T1-T2cN0, Gleason score 2-7 and PSA < 20ng/mL

- American Urological Association Symptom Index Score (ie. IPSS) < 15

- Baseline (post radiotherapy) serum PSA < 10 ng/mL

- Prostate volume as measured by transrectal ultrasound (TRUS) < 50cc

- ECOG performance status 0-1

Exclusion Criteria:

- Prior radiotherapy to the prostate that exceeded 78Gy (2Gy fractions)

- Any of the following prior therapies: transurethral resection of the prostate (TURP),
radionuclide (permanent or temporary implantation) prostate brachytherapy,
prostatectomy or prostatic cryosurgery, HIFU (hi-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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of acute urinary and rectal toxicities

Outcome Description:

Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Outcome Time Frame:

Acute period (<6 months)

Safety Issue:


Principal Investigator

Hans Chung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre, Odette Cancer Centre


Canada: Health Canada

Study ID:




Start Date:

July 2012

Completion Date:

July 2017

Related Keywords:

  • Prostate Cancer
  • prostatic neoplasms
  • brachytherapy
  • salvage therapy
  • recurrent prostate cancer
  • Prostatic Neoplasms