SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sterotactic Body Radiotherapy, Conventionally Fractionated Radiation.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Feasibility Trial of Stereotactic Body Radiotherapy Versus Conventional Fractionation With High Dose-rate (HDR) Brachytherapy Boost for Prostate Cancer
Overview
Random assignment between SBRT and conventionally fractionated boost following HDR brachytherapy for prostate cancer.
Detailed description
Many treatment options exist for prostate cancer. One common treatment approach is to combine high-dose rate (HDR) brachytherapy (temporary insertion of radiation into the prostate) and external beam radiation. External beam radiation typically requires daily radiation treatment for three to five weeks. Improvements to radiation planning and delivery has allowed stereotactic body radiation therapy (SBRT) to be implemented in many types of cancer. SBRT has been implemented as a standard treatment option after HDR brachytherapy in response to the COVID pandemic. We are seeking to evaluate whether it is feasible to randomly assign men between SBRT (which will be five treatments of radiation or conventional radiation (3-5 weeks of daily treatment) following HDR brachytherapy
Interventions
- Radiation Sterotactic Body Radiotherapy
Hypofractionated stereotactic radiation treatment. - Radiation Conventionally Fractionated Radiation
External beam radiation therapy treatment
Primary outcome measures
- Treatment Feasibility [Time frame: 18mo - 2 years]
Secondary outcome measures (10)
- QOL [Time frame: 7 years]
- Treatment Toxicity [Time frame: 7 years]
- Cumulative biochemical failure [Time frame: 7 years]
- Overall Survival [Time frame: 7 years]
- Cancer Free Survival [Time frame: 7 years]
- Metastasis Free Survival [Time frame: 7 years]
- Freedom From Local Failure [Time frame: 7 years]
- Freedom From Regional Failure [Time frame: 7 years]
- ADT Free Survival [Time frame: 7 Years]
- PSA nadir [Time frame: 6 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Sunnybrook Health Sciences Centre — Toronto
Identifiers
NCT: NCT04861415 · 2734