Phase III randomized trial of combined androgen deprivation with high dose rate brachytherapy in locally advanced prostate cancer

UMIN ID: UMIN000001537

Registered date:01/12/2008

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 2008/11/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients receive neoadjuvant hormonal therapy for three months and undergo high dose rate brachytherapy and external radiation therapy with concurrent hormonal therapy. Patients then receive adjuvant hormonal therapy for up to 36 months.
Patients receive neoadjuvant hormonal therapy for three months and undergo high dose rate brachytherapy and external radiation therapy with concurrent hormonal therapy. Patients are followed up without adjuvant hormonal therapy.

Outcome(s)

• Primary Outcome: Biochemical progression-free survival (PFS)
• Secondary Outcome: Overall survival Cause- specific survival Clinical progression-free survival QOL Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male
• Exclude criteria: 1. Patients with other cancer requiring treatment 2. Patients with serious complications 3. Patients who fall under the following(Leukocyte count < 3,000/uL, Hemoglobin < 10.0g/dL, Platelet count < 75,000/uL, AST, ALT and ALP > 2.5 times upper limit of normal (ULN), Serum Creatinine > 1.5 times ULN)

Related Information

• Primary Sponsor: Wakayama Medical University, Department of Urology
• Secondary Sponsor: None
• Source(s) of Monetary Support: Department of Urology Wakayama Medical University,None