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A Multi-institutional Collaborative Study to Evaluate the Efficacy and Safety of Endocrine Therapy (Degarelix, Denosumab, Apalutamide) and Intensity-Modulated Radiation Therapy for Prostate Cancer with Multiple Bone Metastases

A Multi-institutional Collaborative Study to Evaluate the Efficacy and Safety of Endocrine Therapy (Degarelix, Denosumab, Apalutamide) and Intensity-Modulated Radiation Therapy for Prostate Cancer with Multiple Bone Metastases - Multimodal Therapy for Prostate Cancer with Multiple Bone Metastases

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058591
Enrollment
35
Registered
2025-07-24
Start date
2025-07-07
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

After registration, the following drugs will be administered: Degarelix: Initial dose of 240mg administered subcutaneously at two abdominal sites (120mg per site). From the second dose onward, 80mg w

Sponsors

Gifu University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Male prostate cancer patients aged 20 years or older with bone metastases at the time of informed consent 2. Prostate cancer patients with 4 or more bone metastases at the time of registration 3. Patients who can take apalutamide orally 4. Patients who can receive degarelix and denosumab administration 5. Patients with an expected survival of at least 6 months at the time of informed consent 6. Patients with Performance Status (PS) 0 or 1 at the time of informed consent 7. Patients from whom written informed consent for participation in this study can be obtained

Exclusion criteria

Exclusion criteria: 1. Patients with 3 or fewer bone metastases, or patients with visceral metastases other than lung metastases 2. Patients unable to visit the hospital for radiation therapy 3. Patients with osteonecrosis of the jaw at the time of informed consent, or patients with severe dental caries 4. Patients who have received anticancer drug treatment such as docetaxel prior to enrollment in this study 5. Patients who have received radiation therapy (regardless of site) prior to enrollment in this study 6. Patients judged ineligible for participation in this study by the principal investigator or co-investigators at the participating medical institutions of this study

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival (PFS)

Countries

Japan

Contacts

Public ContactTakuya Koie

Gifu University Urology

koie.takuya.h2@f.gifu-u.ac.jp0582306000

Outcome results

None listed

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