5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)
Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment
About This Trial
- This study is looking at whether shorter, more focused radiation treatments work just as well and cause no more side effects than standard radiation given over several weeks.
- It is for people with prostate cancer that has spread to only a few areas in the body and who are planning to be on hormone therapy for at least nine months.
- People with cancer that has spread widely, such as to five or more bone locations or to internal organs, are not eligible.
- Before deciding to join, you should know that the specific radiation option you receive may depend on your urinary health, and you will be asked to fill out regular questionnaires tracking your daily well-being.
More Information
- 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 Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is looking at whether shorter, more focused radiation treatments work just as well and cause no more side effects than standard radiation given over several weeks.
Study Details
- Start Date: July 12, 2021
- Lead Sponsor: British Columbia Cancer Agency
Full Eligibility Criteria
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
Treatments
- Radiation: Hypofractionated external beam radiotherapy
- Radiation: High dose rate brachytherapy
- Radiation: Permanent seed implant
- Radiation: Stereotactic body radiotherapy