Prostate Metastases
Conditions
Brief summary
This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.
Interventions
RADIATIONRadiotherapy
Standard of care radiotherapy administered as per institutional guidelines.
Sponsors
University Health Network, Toronto
TerSera Therapeutics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Histologically-proven prostate cancer * Presence of low-volume or high-volume metastases (high volume defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.) * Planned to or receiving systemic treatment ADT +/- ARAT as per physician discretion (Previous chemotherapy allowed if completed more than 6 weeks prior to randomization.) * Planned for EBRT * ECOG 0 or 1 * Age 18 years or older
Exclusion criteria
* Prior radiotherapy to pelvis * Active ulcerative colitis or Crohn's Disease, at discretion of treating physician * Any condition where radiotherapy is contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of acute toxicity | 5 years | Compare rates of acute toxicity between participants in Arm 1 and Arm 2. Acute toxicity will be measured using CTCAE V5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of late toxicity. | 5 years | Compare rates of late toxicity between participants in Arm 1 and Arm 2. Late toxicity will be measured using CTCAE V5.0 |
| Measure failure-free survival | 5 years | Compare failure-free survival, collected through medical records, for participants in Arm 1 and Arm 2 |
| Quality of Life Outcomes | 5 years | EPIC-26 Questionnaire |
Countries
Canada
Contacts
CONTACTPeter Chung, MD
Outcome results
None listed