Randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicalutamide for patients with metastatic prostate cancer.(KYUCOG-1401).

JRCT ID: jRCTs071180035

Registered date:11/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: metastatic prostate cancer
• Date of first enrollment: 04/09/2014
• Target sample size: 200
• Study type: Interventional

Intervention(s)

armA:
Degarelix 240mg, sc at day 1.
Degarelix 240mg, sc every 4 weeks.
Bicalutamide 80mg daily (as deferred CAB therapy in the case of PSA recurrence).
armB:
Leuprorelin or goserelin: subcutaneous injection every 4 weeks (according to usage and administration of package insert).
Bicalutamide 80mg daily.

Outcome(s)

• Primary Outcome: PSA Progression Free Survival

Secondary Outcome

1. Time to CAB Treatment Failure
(TTF in the case of deferred CAB therapy in antagonist monotherapy group)
2. Overall Survival
3. Progression Free Survival in image diagnosis
4. Radiographic Progression Free Survival
5. Change of PSA
6. Effect on hormone dynamics
7. Change of bone metabolic markers
8. Effect on lipid metabolism
9. Adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1. Histopathological confirmed prostate cancer patients.
2. Patients with metastatic prostate cancer (Stage D1,D2).
3. Patients' survival is expected more than six months.
4. Patients with written informed consent.

Exclude criteria

1. Patients with history of treatment or under treatment on prostate cancer.
2. Patients with active double cancer. Patients with history of malignant tumor within the past 5 years are regarded as having active double cancer. The basal cell carcinoma that radical treatment was taken or superficial squamous cell carcinoma are not included in active double cancer.)
3. Patients with less than 20 years of age on the enrollment day.
4. Any other patients who are regarded as unsuitable for this study by the investigators.

Related Information

• Primary Sponsor: Naito Seiji
• Source(s) of Monetary Support: Astellas Pharma Inc
• Secondary ID(s): UMIN000014243