Upfront therapy in high risk metastatic prostate cancer

JRCT ID: jRCTs021180021

Registered date:25/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: metastatic hormone naive prostate cancer
• Date of first enrollment: 01/04/2016
• Target sample size: 100
• Study type: Interventional
• Intervention(s): patients are assigned to the three groups including ADT, ADT+abiraterone, and ADT+docetaxel according to the patient's preference.

Outcome(s)

• Primary Outcome: Metastatic free survival
• Secondary Outcome: Complete serologic response rate, cancer specific survival, overall survival, adverse event, pain score and frequency of skeltal related event, QOL

Key inclusion & exclusion criteria

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

Include criteria

Patients who meet the criteria as described below will be included:
1.Historically confirmed prostate cancer
2.Metastatic disease on radiographic examinations without any initial treatment
3.20 years and older
4.ECOG performance status 0-2
5.Plan to receive androgen-deprivation therapy including leuteinizing hormone-releasing hormone (LHRH) agonist, LHRH antagonist, surgical castration with and without bicalutamide
6.Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following
criteria
*Leukocyte counts >= 3,000/mm3
*N*Platelets >= 750,000/mm3
*Hemoglobin concentration >= 9.0 g/dL
*AST <= 90IU
*ALT <= 100IU
*Total bilirubin <=2.0mg/dL.
*Serum creatinine, <= 3.0mg/dL
7. Agree with the protocol with signed informed consent

Exclude criteria

Patients who meet the criteria below will be excluded:
1.Severe cardiovascular disease and diabetes mellitus
2.Chronic pulmonary disease
3.Allergy to taxanes
4. Active concomitant malignancy
5. Difficulty of understanding of the trial because of mental disease
6.Inappropriate patients for this study judged by the physicians

Related Information

• Primary Sponsor: Narita Shintaro
• Secondary Sponsor: Habuchi Tomonori