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

Locations

4
British Columbia Cancer Agency Center for the Southern InteriorV1Y5L3, KelownaBritish Columbia, Canada
Fraser Valley Cancer Center SurreyBritish Columbia, Canada
Vancouver Cancer Center VancouverBritish Columbia, Canada
Vancouver Island Cancer Center VictoriaBritish Columbia, Canada

Sponsors and collaborators

British Columbia Cancer Agency

Lead sponsor