Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
Recruiting · NCT05313815 · Interventional (participants receive a specific treatment) · Lead sponsor: University Health Network, Toronto
View the official record on ClinicalTrials.gov →Interventions studied
Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)
What this trial is about
This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age \> 18 years.
- Able to provide informed consent.
- Histologic diagnosis of prostate adenocarcinoma.
- ECOG performance status 0-1.
- High-risk localized disease by NCCN criteria (\>cT3, Grade group \>4, or PSA \>20 ng/mL) or clinical N1 disease.
- Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET))
Exclusion criteria
- Prior pelvic radiotherapy.
- Contraindications to radiotherapy
Where it is running
1 location listed.
- Princess Margaret Cancer Center - Toronto, Ontario, Canada