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New treatment option for Oligometastatic Prostate Cancer
Official title 5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)
ClinicalTrials.gov ID: NCT04610372
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kelowna, British Columbia, Canada
- Surrey, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Victoria, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kelowna, British Columbia, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada; Victoria, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.