Clinical Trial for Tri-Modality Therapy with I-125 Brachytherapy, External Beam Radiation Therapy, and Short- or Long-term Hormone Therapy for High-Risk Localized Prostate Cancer

Phase 3

• Conditions: Prostate Cancer

• Registration Number: JPRN-jRCTs031180252
• Lead Sponsor: AMIKI Mikio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-13
• Study Completion: 2020-03-18
• Results First Posted: 2023-10-04
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 349

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
5) Written informed consent must be obtained from patient

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
11) Patients who had CAB for more than 3 months prior to the registration
12) Patients who are judged inappropriate for the clinical trial by doctors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemical (PSA) progression-free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival<br>Clinical progression-free survival<br>Disease-specific survival<br>Salvage therapy-free survival<br>Metastasis-free survival<br>Evaluation of QOL<br>Evaluation of adverse events