Recruiting NCT05656794
Consolidative Prostate Radiotherapy in Metastatic 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: Radiotherapy.
- Who it may be relevant to
- Registry conditions: Prostate Metastases. Basic parameters: 18 years — 100 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
Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer
Overview
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
- Radiation Radiotherapy
Standard of care radiotherapy administered as per institutional guidelines.
Primary outcome measures
- Rates of acute toxicity [Time frame: 5 years]
Secondary outcome measures (3)
- Rates of late toxicity. [Time frame: 5 years]
- Measure failure-free survival [Time frame: 5 years]
- Quality of Life Outcomes [Time frame: 5 years]
Eligibility criteria
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
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
- University Health Network, Princess Margaret Hospital — Toronto
Identifiers
NCT: NCT05656794 · 22-5921