Phase II trial of neo-adjuvant chemohormonal therapy combining LHRH agonist and estramustine phosphate evaluating PSA failure free survival and safety for locally advanced prostate cancer

Phase II trial of neo-adjuvant chemohormonal therapy combining LHRH agonist and estramustine phosphate evaluating PSA failure free survival and safety for locally advanced prostate cancer - Phase II trial of neo-adjuvant chemohormonal therapy combining LHRH agonist and estramustine phosphate evaluating PSA failure free survival and safety for locally advanced prostate cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001660

Enrollment

Registered

2009-01-27

Start date

2009-02-01

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 receive neo-adjuvant chemohormonal therapy combining LHRH agonist and estramustine phosphate for 6 months and undergo radical prostatectomy.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed adenocarcinoma of the prostate 2) T2cN0M0 or T3N0M0 (UICC2002) 3) Life expectancy of at least 6 months 4) ECOG performance status 0-1 5) Age: 20 - 80

Exclusion criteria

Exclusion criteria: 1) patients with severe co-morbidity including uncontrollable cardiac, cerebral disease. 2) patients with serious liver dysfunction or serious blood disease. 3) patients with gastroenterial ulcer. 4) Patients who had hypersensitivity to Goserelin or Leuprorelin. 5) patients who fall under the followings: AST, ALT and ALP > 2.5 times upper limit of normal (ULN), Serum creatinine > 1.5 times ULN , Leukocyte count < 3,000/uL, Hemoglobin < 10.0g/dL, Platelet count < 75,000/uL 6) Patients with other cancer requiring treatment

Design outcomes

Primary

Measure	Time frame
1.biochemical-progression free survival 2.Safety	—

Secondary

Measure	Time frame
1. Overall survival 2. Cause-specific survival	—

Countries

Japan

Contacts

Public ContactTakuya Koie

Hirosaki University Graduate School of Medicine Urology

urology@cc.hirosaki-u.ac.jp0172-39-5091

Outcome results

None listed

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