pfront therapy in high risk metastatic prostate cancer

Phase 2

Recruiting

• Conditions: metastatic hormone naive prostate cancer; prostate cancer, hormone naive, metastatic

• Registration Number: JPRN-jRCTs021180021
• Lead Sponsor: arita Shintaro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Last Update Posted: 17 October 2023

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
*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

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: Not specified

Primary Outcome Measures

Name	Time	Method
Metastatic free survival

Secondary Outcome Measures

Name	Time	Method
Complete serologic response rate, cancer specific survival, overall survival, adverse event, pain score and frequency of skeltal related event, QO