RCT of Tri-Modalities with I-125 Brachy Therapy and EBRT and Short or Long Term Hormone Therapy for High-risk Localized Prostate Cancer - TRIP STUDY

AMIKI Mikio0 sites349 target enrollmentMarch 13, 2019

ConditionsProstate Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: AMIKI Mikio
Enrollment: 349
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

TRIP trial was designed to determine whether long-term ADT was superior to short-term ADT when combined with brachytherapy and EBRT for localized high-risk prostate cancer. Primary endpoint was PSA progression-free survival (PFS). Secondary endpoints were OS, clinical PFS, disease-specific survival, salvage treatment FS, metastasis FS, and evaluation of QOL and voiding function. There were no significant differences between the two arms in any of the endpoints.

Registry

who.int

Start Date

March 13, 2019

End Date

March 18, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

AMIKI Mikio

Eligibility Criteria

Inclusion Criteria

•1\) Patients with high risk prostate cancer which is defined by PSA value, clinical stage or Gleason score determined by the central pathological judgment.
•High risk is the case where at least one of the following three factors is satisfied
•(1\) PAS\>20 ng/mL prior to CAB
•(2\) Clinical stage of T2c or T3a
•(3\) GS\>\=8 by central pathologists
•2\) Performance status 0\-1 (ECOG)
•3\) Age\>\=40 and \<80 when obtaining the written informed consent
•4\) Patients who satisfy the following (within 14 days prior to the CAB)
•a) Peripheral blood test : WBC\>\=3\.0x103/microL, hemoglobin\>\=10\.0 g/dL, blood plate\>\=10x104/microL
•b) Biological test: serum creatinine\<\=2\.0 mg/dL, AST(GOT)\<\=100 IU/L, ALT(GPT)\<\=100 IU/L

Exclusion Criteria

•1\) Patients who have active double cancer
•2\) Patients with poorly controlled hypertension (i.e., diastolic blood pressure\>\=120 mm Hg)
•3\) Patients with severe psychiatric disorders
•4\) Patients with collagen diseases
•5\) Patients with poorly controlled diabetes
•6\) Patients with poorly controlled ischemic cardiac disease
•7\) Patients who had prior surgery for prostate (transurethral prostatectomy, radical prostatectomy, orchiectomy, other surgery for BPH and/or hyperthermia)
•8\) Patients who had brachytherapy and/or EBRT
•9\) Patients who are taking steroid drugs (except for ointment)
•10\) Patients who are taking other antiandrogen for BPH