Phase III randomized trial of combined androgen deprivation with high dose rate brachytherapy in locally advanced prostate cancer

Phase III randomized trial of combined androgen deprivation with high dose rate brachytherapy in locally advanced prostate cancer - Phase III randomized trial of combined androgen deprivation with high dose rate brachytherapy in locally advanced prostate cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001537

Enrollment

120

Registered

2008-12-01

Start date

2008-11-01

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 neoadjuvant hormonal therapy for three months and undergo high dose rate brachytherapy and external radiation therapy with concurrent hormonal therapy. Patients then receive adjuvant

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the prostate 2. Previously untreated disease 3. Prostate-Specific Antigen (PSA) 20.1-100 ng/mL 4. T2N0M0(Gleason score >or= 8) or T3N0M0(Any Gleason score) 5. Rate of positive core of prostate biopsy >or= 50% 6. ECOG performance status 0-1 7. Age <or= 80

Exclusion criteria

Exclusion criteria: 1. Patients with other cancer requiring treatment 2. Patients with serious complications 3. Patients who fall under the following(Leukocyte count < 3,000/uL, Hemoglobin < 10.0g/dL, Platelet count < 75,000/uL, AST, ALT and ALP > 2.5 times upper limit of normal (ULN), Serum Creatinine > 1.5 times ULN)

Design outcomes

Primary

Measure	Time frame
Biochemical progression-free survival (PFS)	—

Secondary

Measure	Time frame
Overall survival Cause- specific survival Clinical progression-free survival QOL Safety	—

Countries

Japan

Contacts

Public ContactIsco Hara, M.D.

Wakayama Medical University Department of Urology

hara@wakayama-med.ac.jp073-441-0637

Outcome results

None listed

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