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)

Not Applicable

• Conditions: Prostate cancer treated after radiotherapy

• Registration Number: JPRN-UMIN000020674
• Lead Sponsor: Hirosaki University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-21
• Study Completion: 2022-07-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline to 12 Week of International Prostate Symptom Score (IPSS)

Secondary Outcome Measures

Name	Time	Method
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