High-dose-rate brachytherapy as monotherapy for intermediate- and high-risk prostate cancer: A phase II clinical trial

High-dose-rate brachytherapy as monotherapy for intermediate- and high-risk prostate cancer: A phase II clinical trial - Monotherapeutic HDR-BT for intermediate- and high-risk prostate cancer: Phase II

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020206

Enrollment

100

Registered

2015-12-20

Start date

2015-12-25

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Prostate cancer

Interventions

Irradiation using high-dose-rate brachytherapy. In total 40 Gy in five fractions (8 Gy per fraction) will be given, with at least 6-hour intervals, at most twice a day, in consecutive 3 days.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Biopsy-proven adenocarcinoma 2) MRI, CT, bone scintigraphy were done, and no lymph node or distant metastasis was detected 3) T1c-4N0M0 4) Intermediate- or high-risk prostate cancer (any of T2b-4, GS >=7, or PSA >=10) 5) No neoadjuvant hormone therapy or <= 1 year if any 6) No apparent deficiency of hematological tests 7) Candidacy of epidural anesthesia 8) Age >=20, <80 9) Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1) Active other malignancy 2) Uncontrollable diabetes mellitus 3) Unstoppable anticoagulant drugs 4) Severe neurocognitive disease 5) Collagen disease 6) Previous surgery or irradiation to the pelvis 7) Previous TUR-P 8) Severe BPH or lower urinaly tract symptoms 9) Low-risk prosatate cancer 10) High-risk prostate cancer with all 3 factors of T3-4, GS >=, and PSA >=20 11) Neoadjucant hormone therapy >1 year 12) Castration-resistant prostate cancer 13) The physician juddged contraindication

Design outcomes

Primary

Measure	Time frame
5-year actuarial biochemical control rate	—

Secondary

Measure	Time frame
5-year actuarial rate of late adverse events (genitourinary and gastrointestinal Grade 3 or more), 5-year actuarial rate of late adverse events (genitourinary and gastrointestinal Grade 2 or more), and QOL questionnaire (EPIC + SF-8)	—

Countries

Japan

Contacts

Public ContactTakero Hirata

Osaka University Graduate School of Medicine Radiation Oncology

hirata@radonc.med.osaka-u.ac.jp06-6879-3482

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026