Clinical Trial: 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 (Japan)

Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058591) titled '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' on July 24.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Gifu University

Condition: Condition - Prostate Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - o investigate whether multidisciplinary treatment combining hormone therapy and radiation therapy can improve biochemical recurrence and survival rates in prostate cancer patients with multiple bone metastases. Additionally, to examine treatment-related adverse events, patient backgrounds and oncological characteristics of patients who benefit from this treatment. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - 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 will be administered as a maintenance dose subcutaneously at one abdominal site every 4 weeks. Alternatively, from the second dose onward, 480mg may be administered as a maintenance dose subcutaneously at two abdominal sites every 12 weeks. Denosumab: 120mg administered subcutaneously once every 4 weeks. Calcium supplements will be administered to prevent hypocalcemia caused by this drug. Apalutamide: 240mg administered orally once daily (refer to package insert).

One year after treatment initiation, if no apparent disease progression is observed on imaging and blood tests, intensity-modulated radiation therapy will be administered to the prostate and bone metastatic lesions. The treatment outline is described below: Intensity-Modulated Radiation Therapy for Prostate: Depending on prostate size and disease status, 2Gy per fraction for 36-39 fractions will be delivered to the prostate (total 72-78Gy). Treatment is typically administered once daily on weekdays (Monday through Friday), completing treatment over approximately 7-8 weeks. Radiation Therapy for Bone Metastases: 2.5Gy per fraction for 15 fractions will be delivered to bone metastatic lesions (total 37.5Gy). Treatment is typically administered once daily on weekdays (Monday through Friday), completing treatment over approximately 3 weeks.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male Key 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 Key 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 Target Size - 35

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 07 Month 07 Day Date of IRB - 2025 Year 07 Month 07 Day Anticipated trial start date - 2025 Year 07 Month 07 Day Last follow-up date - 2033 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066988

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