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

RecruitingNAAges 18 Years - anyMaleBritish Columbia Cancer Agency
NCT04610372 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (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 favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Signed study specific informed consent * European Cooperative Oncology Group performance status 0 to 2 * Histologically confirmed adenocarcinoma of the prostate * Any Tumor stage, any T, any N, M1 * No prior therapy for prostate cancer apart from androgen deprivation * Planned for long-term androgen deprivation therapy (greater than 9 months in duration) * Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study * For brachytherapy arms, patient must be technically suitable for brachytherapy according to investigator, in terms of bladder function and prostate size. Exclusion Criteria: * High metastatic burden defined as 5 or more bone metastases or visceral metastases * Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation * For Brachytherapy Arms =: Any prior Transurethral resection of prostate
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What it tests

  • Hypofractionated external beam radiotherapy
  • High dose rate brachytherapy
  • Permanent seed implant
  • Stereotactic body radiotherapy
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Where

4 sites
British Columbia Cancer Agency Center for the Southern Interior
Kelowna, Canada
Fraser Valley Cancer Center
Surrey, Canada
Vancouver Cancer Center
Vancouver, Canada
Vancouver Island Cancer Center
Victoria, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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