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Effect of tadarafil on lower urinary tract symptoms in patients treated with low dose rate brachytherapy for prostate cancer

Effect of tadarafil on lower urinary tract symptoms in patients treated with low dose rate brachytherapy for prostate cancer - TABRAP study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047981
Enrollment
220
Registered
2022-06-10
Start date
2022-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

Silodosin Silodosin plus Tadalafil

Sponsors

Nara Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1, cT1-T3aN0M0 prostate cancer diagnosed by prostate biopsy, technetium-99 m [99 m-Tc] bone scans, computed tomography, and magnetic resonance imaging 2, Adult men aged 20-80 years 3, Performance Status 0-2 4, Men who undergo 125I-brachytherapy for prostate cancer 5, Prostate volume > 15mL based on MRI before treatment

Exclusion criteria

Exclusion criteria: 1 Patients who take nitric acid agents 2 Allergy to tadalafil 3 Unstable angina 4 Heart failure NYHA3 or more 5 Uncontrolled arrhythmia or hypotension 6 Myocardial infarction within 3 months 7 Cerebral infarction or hemorrhage within 6 months 8 Patients who take PDE 5 inhibitor 9 Ineligibility judged by the investigator due to medical, psychological or other reason

Design outcomes

Primary

MeasureTime frame
The change in mean 24-hour urinary frequency for 3 days at 3 months after I125 brachytherapy from baseline

Secondary

MeasureTime frame
The changes in IPSS, OABSS, and EPIC score; post-voiding residual urine; and mean volume voided per micturition from baseline at 3 months after I125 brachytherapy urinary frequency for 3 days at 1 month and 3 months after I125 brachytherapy from baseline

Countries

Japan

Contacts

Public ContactYasushi Nakai

Nara Medical University Department of Urology

nakaiyasusiuro@live.jp0744240345

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026