Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer
NCT ID: NCT05656794
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2023-07-31
2031-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 - Investigational
Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).
Radiotherapy
Standard of care radiotherapy administered as per institutional guidelines.
Arm 2 - Standard
Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.
Radiotherapy
Standard of care radiotherapy administered as per institutional guidelines.
Interventions
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Radiotherapy
Standard of care radiotherapy administered as per institutional guidelines.
Eligibility Criteria
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Inclusion Criteria
* 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
* Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
* Any condition where radiotherapy is contraindicated
18 Years
100 Years
MALE
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Locations
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University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-5921
Identifier Type: -
Identifier Source: org_study_id
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