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Multi-institutional study to evaluate the efficacy and safety of hormone therapy with radiation therapy for prostate cancer with multiple bone metastases

Multicenter study to evaluate the efficacy and safety of combination therapy with LHRH antagonist, androgen-receptor signaling inhibitor, and denosumab followed by local radiation therapy in patients with multiple metastatic prostate cancer - Efficacy of multidisciplinary treatment including radiotherapy for prostate cancer with multiple bone metastases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054497
Enrollment
30
Registered
2024-05-28
Start date
2021-12-01
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

Patients with prostate cancer who had multiple bone metastases

Interventions

Degarelix, Denosumab, Enzarutamide, Radiation

Sponsors

Department of Urology, Gifu University Graduate School of Medicine Takuya Koie
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: histologically confirmed PCa with high burden synchronous metastatic disease (4 and more bone metastases), Eastern Cooperative Oncology Group performance status of 0-1, adequate bone marrow function (absolute neutrophil count 1500/m3 and more and platelet count 100000/m3 and more), adequate renal function (creatinine 2.0 mg/dL and less and/or creatinine clearance 40 mL/min and more), and adequate hepatic function (total bilirubin 1.5 mg/dL and less).

Exclusion criteria

Exclusion criteria: Patients who had previously undergone RT for the prostate or pelvis, or had received chemotherapy or hormonal therapy for PCa, were excluded. The patients who received finasteride or dutasteride before the surgery were also excluded from the present study.

Design outcomes

Primary

MeasureTime frame
Efficacy of this combination treatments on oncological outcomes

Countries

Japan

Contacts

Public ContactMakoto Kawase

Gifu University Graduate School of Medicine Urology

kawase.makoto.g5@f.gifu-u.ac.jp0582306000

Outcome results

None listed

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