EORTC 1333-GU: A Randomized multicenter phase III trial comparing enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone (PEACE III)

Conditions

Castration resistant prostate cancer patients metastatic to bone.

Brief summary

Radiological Progression free survival (rPFS1)

Detailed description

Overall survival, Prostate-cancer specific survival, First symptomatic skeletal event (SSE), Time and incidence of first skeletal progression-free survival, Rate of skeletal fractures, Time to next systemic anti-neoplastic therapy, Treatments elected after first disease progression, Second progression-free survival, Safety according to Common Terminology Criteria for Adverse Events, Pain: Brief Pain Inventory (BPI). In this study only pain related to prostate cancer is considered, Time to pain progression (defined as an increase of 2 or more points in the "worst pain in 24 hours" score from baseline observed at 2 consecutive evaluations ≥ 4 weeks apart OR initiation of short or longacting opioid use for pain), Time to opiate use for cancer-related pain, Quality of Life (EQ-5D-5L)

Related papers

No related papers found yet.

Interventions

DRUGXtandi - 40 mg soft capsules

DRUGXofigo 1100 kBq/mL solution for injection

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Radiological Progression free survival (rPFS1)	—

Secondary

Measure	Time frame
Overall survival, Prostate-cancer specific survival, First symptomatic skeletal event (SSE), Time and incidence of first skeletal progression-free survival, Rate of skeletal fractures, Time to next systemic anti-neoplastic therapy, Treatments elected after first disease progression, Second progression-free survival, Safety according to Common Terminology Criteria for Adverse Events, Pain: Brief Pain Inventory (BPI). In this study only pain related to prostate cancer is considered, Time to pain progression (defined as an increase of 2 or more points in the "worst pain in 24 hours" score from baseline observed at 2 consecutive evaluations ≥ 4 weeks apart OR initiation of short or longacting opioid use for pain), Time to opiate use for cancer-related pain, Quality of Life (EQ-5D-5L)	—

Measure

Time frame

Overall survival, Prostate-cancer specific survival, First symptomatic skeletal event (SSE), Time and incidence of first skeletal progression-free survival, Rate of skeletal fractures, Time to next systemic anti-neoplastic therapy, Treatments elected after first disease progression, Second progression-free survival, Safety according to Common Terminology Criteria for Adverse Events, Pain: Brief Pain Inventory (BPI). In this study only pain related to prostate cancer is considered, Time to pain progression (defined as an increase of 2 or more points in the "worst pain in 24 hours" score from baseline observed at 2 consecutive evaluations ≥ 4 weeks apart OR initiation of short or longacting opioid use for pain), Time to opiate use for cancer-related pain, Quality of Life (EQ-5D-5L)

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Countries

Belgium, Denmark, France, Ireland, Italy, Norway, Poland, Spain

Outcome results

None listed