A Randomized, Open-Label, Multicenter study to evaluate effect of tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy (T-addon-RT trial)

A Randomized, Open-Label, Multicenter study to evaluate effect of tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy (T-addon-RT trial) - A Randomize study to evaluate effect of tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020674

Enrollment

100

Registered

2016-01-21

Start date

2016-01-20

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 treated after radiotherapy

Interventions

Tadalafil 5mg one a day, for 12 weeks Observation for 12 weeks, continuation of concomitant argents

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Males, 20 years or older, in patients with prostate cancer treated after radiotherapy;, including lower urinary tract symptoms (IPSS>7, or nocturia >1) who were not taking tadalafil Agree not to change prostate cancer or use erectile dysfunction treatments anytime during the study Have not taken phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 1. Without biochemical recurrence (prostate specific antigen < 2.0) at the visit 1.

Exclusion criteria

Exclusion criteria: Prostate specific antigen (PSA) beyond 2.0 ng/mL defined for study at Visit 1. History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1. History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1. Clinical evidence of recurrent prostate cancer at Visit 1. Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1. History of cardiac conditions, including angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study. History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1. Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to tadalafil

Design outcomes

Primary

Measure	Time frame
Change from Baseline to 12 Week of International Prostate Symptom Score (IPSS)	—

Secondary

Measure	Time frame
Change from Baseline to 12 Week of IPSS Irritative Subscore IPSS Voiding (Obstructive) Subscore IPSS Quality of Life (QoL) Index Uroflowmetry Parameter: Peak Flow Rate (Qmax) Number of Participants with Adverse Events International Index of Erectile Function (IIEF) Blood Pressure Postvoid Residual Volume (PVR) Prostate Specific Antigen (PSA) Testosterone oxygen stress	—

Countries

Japan

Contacts

Public ContactShingo Hatakeyama

Hirosaki University Graduate School of Medicine Department of Urology

shingorilla2@gmail.com+81172395091

Outcome results

None listed

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