VIGOR Study

Not Applicable

Recruiting

• Conditions: Stage: Stage I-II; prostate cancer

• Registration Number: JPRN-jRCTs052230106
• Lead Sponsor: Onishi Kenta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1) Disease: Prostate cancer
2) Stage: Stage 1-2
3) Age: 20-75 years old
4) Gender: Male
5) ECOG PS (Performance Status) 0-1
6) Mild to moderately preserved sexual function before brachytherapy (SHIM more than 12 points)
7) Patients treated with brachytherapy alone
8) Patients planning to have sexual intercourse before or after surgery
9) Patients who have given written consent to participate in this clinical study

Exclusion Criteria

1) Patients with cognitive impairment
2) Patients with poorly controlled diabetes mellitus (HbA1c of 10% or higher)
3) Patients with neurological disease
4) Patients undergoing adjuvant hormonal therapy (surgical castration or medical castration) for brachytherapy
5) Patients receiving external radiation therapy as adjuvant therapy to brachytherapy
6) Patients taking PDE5 inhibitors
7) Patients using vacuum constriction device
8) Patients on antithrombotic therapy or predisposed to bleeding
9) Patients who have difficulty operating vacuum constriction device
10) Patients who are deemed inappropriate as research subjects by the principal investigator or subinvestigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified