5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)
Recruiting · NCT04610372 · Interventional (participants receive a specific treatment) · Lead sponsor: British Columbia Cancer Agency
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
4 locations listed.
- British Columbia Cancer Agency Center for the Southern Interior - Kelowna, British Columbia, Canada
- Fraser Valley Cancer Center - Surrey, British Columbia, Canada
- Vancouver Cancer Center - Vancouver, British Columbia, Canada
- Vancouver Island Cancer Center - Victoria, British Columbia, Canada