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Clinical Trials/NCT04245670
NCT04245670
Active, not recruiting
Not Applicable

5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC)

Sunnybrook Health Sciences Centre1 site in 1 country75 target enrollmentMay 31, 2018
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ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
75
Locations
1
Primary Endpoint
Acute Toxicity
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.

5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.

Registry
clinicaltrials.gov
Start Date
May 31, 2018
End Date
January 31, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Acute Toxicity

Time Frame: Baseline to 3 months post completion of treatment

To document the acute bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria

Secondary Outcomes

  • Economic analysis(Baseline to end of 5 year follow up)
  • Quality of Life outcome(Baseline to end of 5 year follow up)
  • Biochemical disease-free survival(Baseline to end of 5 year follow up)
  • Quality of life outcome(Baseline to end of 5 year follow up)

Study Sites (1)

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