Upfront therapy in high risk metastatic prostate cancer (UFAD in mHNPC)

Recruiting

• Conditions: metastatic hormone naive prostate cancer

• Registration Number: jRCTs021180021

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2019-03-25
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 100

Inclusion 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
   NPlatelets >= 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Metastatic free survival