Pilot study for randomized clinical trial of bicaltamide alone versus bicaltamide plus goserelin acetate in patients with PSA failure after radical prostatectomy

Pilot study for randomized clinical trial of bicaltamide alone versus bicaltamide plus goserelin acetate in patients with PSA failure after radical prostatectomy - Pilot study for randomized clinical trial of androgen deprivation therapy in patients with PSA failure after radical prostatectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002822

Enrollment

Registered

2009-12-02

Start date

2009-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

Patients are randomized to arm 1 or arm 2 according to age, PSA levels, Gleason score and institutes. Arm 1. Bicaltamide alone Daily oral bicaltamide 80 mg for 3 years. Arm 2. Combined androgen b

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients must be diagnosed as prostate cancer pathologically. 2) Patients must have a PSA level of 1.0 ng/ml after radical prostatectomy. 3) Patients did not receive any prior hormonal therapy as adjuvant or neo-adjuvant setting. 4) Patients must satisfy the followings: WBC >= 2500/mm3 Lymphocyte >= 1000/mm3 Hb >= 8.0g/dl Platelet >= 80000/mm3 Serum Creatinine <= 2.5 x upper limit of normal Total Bilirubin <= 2 x upper limit of normal 5) Patients must be at a score level of 0-1 of performance status (PS) (EOCG) 6) Patients must be more 20 year-old. 7) Written informed consent must be obtained from patients.

Exclusion criteria

Exclusion criteria: The following patients must be excluded: 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2) Patients with the past history of severe allergic reactions. 3) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4) Patients who are judged inappropriate for the clinical trial by doctors.

Design outcomes

Primary

Measure	Time frame
Clinical relapse-free survival	—

Secondary

Measure	Time frame
1.Evaluation of quality of life (EPIC) 2.Rate of adverse events is evaluated based on the NCI-CTCAE (Ver.3) 3.Overall survival 4.Cause specific survival 5.PSA progression free survival	—

Countries

Japan

Contacts

Public ContactAkira Yamada

Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division

akiymd@med.kurume-u.ac.jp0942-31-7744

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026