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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorBritish Columbia Cancer Agency

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

168 Participants
are divided into 4 treatment groups

Sponsors and collaborators