VIGOR Study

JRCT ID: jRCTs052230106

Registered date:28/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stage: Stage I-II
• Date of first enrollment: 28/09/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Use of a vacuum constriction device for 15 minutes once every 2 days beginning at the time of urethral catheter removal after brachytherapy.

Outcome(s)

• Primary Outcome: SHIM score at 6 months after brachytherapy

Secondary Outcome

SHIM score at 1 month and 3 months after brachytherapy
Quality of life at 1 month, 3 months after after brachytherapy, and at the end of intervention (6 months after after brachytherapy)
Change in penile blood flow before after brachytherapy, after 1 month , after 3 months of after brachytherapy, and at the end of intervention (after 6 months of brachytherapy)
Change in penile length and penile circumference before and 1 month , 3 months after brachytherapy, and at the end of intervention (6 months after brachytherapy)
Change in testosterone levels and body composition before and 1 month , 3 months after brachytherapy, and at the end of the intervention (6 months after brachytherapy)
Change in Pittsburgh Sleep Quality Index global score (PSQIG) before and 3 months after brachytherapy
Change in nocturia after 1 month, 3 months after brachytherapy, and at the end of intervention (after 6 months brachytherapy)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Onishi Kenta
• Secondary Sponsor: Tanaka Nobumichi
• Source(s) of Monetary Support: ALTECH Corporation