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Prophylactic vs Therapeutic Rapaflo in Prostate Cancer RT
NCT02220829Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2016
- Primary completion
- Apr 2023
- Countries
- 1
- Sponsor
- Jewish General Hospital
- Modality
- Small Molecules
- Drugs
- silodosin
- Conditions
- lower urinary tract symptoms (LUTS)
01
Overview
Phase 3, randomised, open-label trial of silodosin in lower urinary tract symptoms (LUTS) (2 arms), sponsored by Jewish General Hospital. Primary endpoint: Rate of increase and mean difference from baseline IPSS score at 12 months. Started Jun 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Preventive Rapaflo
Rapaflo 8mg daily starting Day 1 of RT for 4 months, then 8mg q48h for 2 months.
Standard Care
Rapaflo 8mg daily only at onset of symptoms until resolution.
03
Who it enrols
Adult males with confirmed adenocarcinoma of the prostate (T1a-T3b) undergoing primary EBRT +/- HDR boost.
04
Endpoints
Primary
Rate of increase and mean difference from baseline IPSS score
Secondary
Rate of IPSS return to baseline
Rate of therapy dependence
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