Skip to content

Multi-institutional prospective trial on safety and efficacy of high dose rate brachytherapy as monotherapy for prostate cancer.

Multi-institutional prospective trial on safety and efficacy of high dose rate brachytherapy as monotherapy for prostate cancer. - Multi-institutional prospective trial on safety and efficacy of high dose rate brachytherapy as monotherapy for prostate cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031106
Enrollment
100
Registered
2018-02-01
Start date
2018-02-01
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

High dose rate brachytherapy (27 Gy / 2 fractions) Androgen deprivation therapy according to risk classification.

Sponsors

National Cancer Center Hospital, Japan. Department of Radiation Oncology.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Pathologically diagnosed prostate adenocarcinoma. 2) T1c-3bN0M0 3) PSA value under 50 ng/ml 4) Gleason score 6-10 5) Low, intermediate, high and very high risk (NCCN risk classification 2016) 6) Age :20-80 7) Performance status (ECOG) 0-1 8) Written informed consent 9) Patient chooses this trial method.

Exclusion criteria

Exclusion criteria: 1) Other cancers 2) Uncontrolled Diabetes Mellitus 3) Severe comobidity such as collagen disease, heart disease, respiratory disease and liver disease. 4) Patient with severe psychiatric disease. 5) Privious medical history of pelvic irradiation. 6) Privious medical history of surgery or HIFU for prostate cancer. 7) Chemotherapy (except androgen deprivation therapy) for prostate cancer. 8) Inflammatory bowel disease 9) IPSS score more than or equal to 22. 10) Difficult to protect dose constraints for normal tissue. 11) Attending physician judges it is not suitable for the study.

Design outcomes

Primary

MeasureTime frame
1. The occurence of more than or equal to Grade 3 late adverse effects in two years. 2. 5 year PSA relapse free rate.

Countries

Japan

Contacts

Public ContactKoji Inaba

National Cancer Center Hospital, Japan. Department of Radiation Oncology

koinaba@ncc.go.jp03-3542-2511

Outcome results

None listed

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