Phase III Radium 223 mCRPC-PEACE III (PEACE III)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02194842|
Recruitment Status : Recruiting
First Posted : July 18, 2014
Last Update Posted : June 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Ra223 Drug: Enzalutamide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||416 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
Active Comparator: Enzalutamide
Enzalutamide will be given at a dose of 160 mg daily
Experimental: Enzalutamide and Ra223
Ra223 will be administered 55kBq/kg standard dose monthly for 6 months and given in combination with enzalutamide at a dose of 160 mg daily.
- radiological progression-free survival [ Time Frame: 46 months after first patient entry ]
Radiological progression free survival (rPFS1) is defined according to the recommendations of the "Prostate-Cancer clinical trials Working Group" version 3 and referred to as the "PCWG3"; for the setting "delay/prevent" progression.
An event of progression according to their definition is either of:
- Objective progression of the disease according to RECIST criteria for soft tissue lesions with the additional requirement that progression at the first follow-up assessment be confirmed by a second scan ≥ 6 weeks apart
- Appearance of ≥ 2 new bone lesions and for the first follow-up assessment only (i.e. within 12 weeks, during the flare period), a confirmatory scan performed ≥ 6 weeks later that shows a minimum of two or more additional new lesions (2+2 criterion)
In this protocol:
• PSA progression is not considered disease progression and should NOT trigger a change of treatment.
- Overall survival [ Time Frame: 63 months after first patient entry ]number of participants
- prostate cancer specific survival [ Time Frame: 63 months after first patient entry ]number of participants
- First symptomatic skeletal event [ Time Frame: 46 and 63 months after first patient entry ]number of participants
- Time and incidence of first skeletal progression-free survival [ Time Frame: 46 and 63 months after first patient entry ]number of participants
- Time from entry to initiation of next systemic anti-neoplastic therapy [ Time Frame: 46 and 63 months after first patient entry ]number of participants
- Treatments elected after first disease progression [ Time Frame: 46 and 63 months after first patient entry ]number of participants
- Second progression-free survival in sequential regimen [ Time Frame: 46 and 63 months after first patient entry ]number of participants
- Patient self-rate scale assessing the pain associated to prostate cancer [ Time Frame: 46 and 63 months after first patient entry ]Brief Pain Inventory questionnaire: BPI questionnaire is a validated instrument that is a patient self-rated scale assessing level of pain, effect of the pain on activities of daily living, and analgesic use. The BPI also measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The short form of the BPI is used in this study. It is intended to capture two dimensions of pain: severity and interference. This short version of the BPI contains four pain severity items and seven pain interference items rated on 0-10 scales and uses a 24-hour recall period.
- Time to pain progression [ Time Frame: 63 months after first patient entry ]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 long-acting opioid use for pain
- Occurence of adverse events [ Time Frame: 63 months after first patient entry ]Adverse events will be graded according to the "Common Terminology Criteria for Adverse events" CTCAE, version 4.0
- Time to opiate use for cancer-related pain [ Time Frame: 63 months after first patient entry ]number of participants
- Patient self-rate scale assessing the Quality of Life [ Time Frame: 46 and 63 months after first patient entry ]
EQ5D-5L questionnaire asks respondents to simply 'mark an X on the scale to indicate how your health is TODAY' and then to 'write the number you marked on the scale in the box below'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
The respondent is asked to indicate his health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. It should be noted that the numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.
- rate of skeletal fractures [ Time Frame: 63 months after first patient entry ]The rate of skeletal fractures per patient/year of follow-up will be estimated in each treatment arm using recurrent-event analysis methods. Analyses by type of fracture (e.g. pathological fracture) will also be conducted as appropriate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194842
|Contact: EORTC||+32 2 774 16 email@example.com|
|Study Chair:||Bertrand Tombal, Prof||Cliniques Universitaires de Saint Luc|
|Study Chair:||Silke Gillessen, Prof||Oncology Institute of Southern Switzerland - Ospedale San Giovanni|