NCT04236752|UnknownDMC
Stereotactic Pelvic Brachytherapy With HDR Boost for Dose Escalation in High Tier Intermediate and High Risk Prostate ca
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Sponsor study identifier
interventional
33
1 country
1
Study Start
September 29, 2014
Actual (reported)Primary Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
HDR brachytherapy in conjunction with pelvic SABR in high tier intermediate and high risk prostate cancer patients can provide a safe and effective means of radiotherapy dose escalation. Utilizing multiparametric MRI to focally boost the dominant intraprostatic lesion during HDR brachytherapy is safe and feasible.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 29, 2014
Actual (reported)May 31, 2019
Actual (reported)January 22, 2020
Actual (reported)December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Acute GI and GU toxicities
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v3.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks. This will be calculated using the F distribution method (exact confidence limits).
Baseline (start of treatment) to 6 weeks post completion of Radiation treatment
Late GI and GU RTOG toxicities
6 months post start of treatment to end of 5 year follow up post completion of treatment
Quality of Life outcome- EPIC
Baseline ( start of treatment) to end of 5 year follow up post completion of treatment
Biochemical disease-free survival
Baseline ( start of treatment) to end of 5 year follow up post completion of treatment
Quality of Life outcome- EQ5D
Baseline to end of 5 year follow up post completion of treatment
Quality of Life outcome- PORPUS-U
Baseline ( start of treatment) to end of 5 year follow up post completion of treatment
HDR Brachytherapy Boost of 15Gy to the prostate followed by Stereotactic Ablative Body Radiation (SBRT) 25 Gy in 5 fractions, once weekly to prostate, SVs and pelvic lymph nodes + 6-18 months of ADT
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sunnybrook Health Sciences Center
Toronto, Ontairo, M4N 3M5, Canada
33 participants (actual enrollment reported by the registry).
First Submitted
May 31, 2019
First Posted
January 22, 2020
Study Start
September 29, 2014
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 22, 2020
Record last verified: 2020-01
Overall study data will be available thru publications. Individual Participants Data will not be made public.
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Source: ClinicalTrials.gov.
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