5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)

Official Title

Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment

Summary:

We will investigate whether ultrahypofractionation using stereotactic ablative radiation therapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiation therapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favourable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.

Trial Description

Primary Outcome:

  • Urinary symptoms
Secondary Outcome:
  • Expanded Prostate Cancer Index (EPIC) urinary domain
  • EPIC bowel domain
  • EPIC sexual domain
  • Biochemical failure (time to increase in prostate specific antigen (ng/ml) to 50% > nadir
  • Distant metastatic failure
  • Nodal progression
  • Overall survival
  • Cause specific survival
  • Cost effectiveness
Men newly diagnosed with low volume oligometastatic prostate cancer defined as fewer than 5 bone metastases and/or non regional lymph node involvement who agree to treatment of the primary cancer with radiation will be randomized between standard moderately hypofractionated external radiation therapy (5500 centiGray/20 fractions as per Stampede trial) and one of 3 alternatives: stereotactic body radiation therapy (SABR) to deliver 36 Gy/5 fractions, or low dose rate Iodine 125 permanent seed implant or a single high dose rate temporary implant. The trial will take place in 4 regional cancer centres of British Columbia Cancer Agency, with each centre choosing their preferred alternative to 5500/20. To achieve 4 equally sized treatment arms, each randomization is weighted 3:1 for 42 patients in each arm and 168 total accrual. The primary endpoint is urinary quality of life as assessed by the International Prostate Symptom Score (IPSS) . As the typical acute symptoms from each of these radiation modalities has a unique time course, assessments are done at 6 different points during the first 2 years. Secondary endpoints are global quality of life as assessed by Expanded Prostate Cancer Index (EPIC) urinary, bowel and sexual scores, progression free survival, overall survival and cost effectiveness.

View this trial on ClinicalTrials.gov

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Resources

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