SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer
Recruiting · NCT04861415 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Conventionally Fractionated RadiationSterotactic Body Radiotherapy
What this trial is about
Random assignment between SBRT and conventionally fractionated boost following HDR brachytherapy for prostate cancer.
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 or older
- Informed consent for treatment and study participation completed
- Pathologically proven diagnosis of prostate adenocarcinoma
- ECOG Performance Status 0-2
- No prior history of pelvic radiotherapy, brachytherapy, cryosurgery, HIFU, TURP or radical prostatectomy
Exclusion criteria
- Presence of nodal or distant metastasis on staging MRI or CT Abdomen/Pelvis and Bone scan within 90 days of enrolment (CT/MRI/Bone Scan are only required if the clinical risk of metastatic disease is sufficient to warrant these scans)
- Plan for adjuvant chemotherapy post-radiotherapy
- Serious medical comorbidities or other contraindications to HDR brachytherapy
- Presence of inflammatory bowel disease
- Presence of connective tissue disorder seen as a contraindication to radiotherapy
- Medically unfit for general/spinal anesthesia
- Unable or unwilling to complete questionnaires
Where it is running
1 location listed.
- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada