Prostate Cancer
Conditions
Brief summary
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
RADIATIONSterotactic Body Radiotherapy
Hypofractionated stereotactic radiation treatment.
RADIATIONConventionally Fractionated Radiation
External beam radiation therapy treatment
Sponsors
Dr. Gerard Morton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Feasibility | 18mo - 2 years | The proportion of patients accepting of being randomized divided by the number of patients approached for the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Toxicity | 7 years | Proportion of patients with urinary, bowel and sexual Grade 2 and 3 toxicity measured by CTCAE v5.0 throughout the study period. |
| Cumulative biochemical failure | 7 years | Defined as the time of enrolment to biochemical failure (based on the Phoenix definition, PSA nadir plus 2) |
| Overall Survival | 7 years | Defined as time of enrollment to death from any cause |
| Cancer Free Survival | 7 years | Defined as time of enrolment to death attributed to prostate cancer |
| QOL | 7 years | Urinary, bowel and sexual health-related quality of life measured by the Expanded Prostate Cancer Index Composite (EPIC) domains over the study period. Each domain is normalized from 0 to 100, with a higher score indicating better outcome. |
| Freedom From Local Failure | 7 years | Defined as time of enrolment to first local recurrence |
| Freedom From Regional Failure | 7 years | Defined as time of enrolment to first regional recurrence |
| ADT Free Survival | 7 Years | Defined as time of enrolment to salvage ADT use or death from any cause |
| PSA nadir | 6 years | PSA nadir at 4-years post treatment |
| Metastasis Free Survival | 7 years | Defined as time of enrolment to development of metastasis or death from any cause |
Countries
Canada
Contacts
Primary ContactGerard Morton, MD
Backup ContactMerrylee McGuffin
Outcome results
None listed