Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Overall Response Rate (ORR) |
Response will be measured according to RECIST version 1.1, the ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient. |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
|
| Primary |
Duration of Response (DoR) |
Response will be measured according to RECIST version 1.1, the DoR is defined as the time from first tumor assessment at which the overall response was recorded as partial response (PR) or complete response (CR) that is subsequently confirmed until documented progressive disease (PD) or death form any cause, whichever occurs first. |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
|
| Secondary |
Progression Free Survival (PFS) |
Response will be measured according to RECIST version 1.1, the PFS is defined as the time from study enrolment until date of first documented disease progression or death due to any cause, whichever occurs first.Every 12 weeks a CT/MRI scan will be made to asses the progression free survival until PD. |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
|
| Secondary |
Clinical benefit rate (CBR) |
Response will be measured according to RECIST version 1.1, the CBR is defined as the confirmed CR or PR at any time or stable disease (SD) of at least 6 months. Every 12 weeks a CT/MRI scan will be made to asses the clinical benefit rate until PD. |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
|
| Secondary |
Overall survival (OS) |
The OS is defined as the time from study enrolment to the date of death to any cause. |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years |
|
| Secondary |
Quality of Life (QoL) based on the EORTC QLQ-C30 questionnaire |
Quality of Life (QoL) based on the EORTC QLQ-C30 questionnaire. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD. |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
|
| Secondary |
Quality of Life (QoL) based on the EORTC QLQ-H&N43 questionnaire |
Quality of Life (QoL) based on the EORTC QLQ-H&N43 questionnaire. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD. |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
|
| Secondary |
Quality of Life (QoL) based on the EORTC QLQ-SHQ22 questionnaire |
Quality of Life (QoL) based on the EORTC QLQ-SHQ22 questionnaire. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD. |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
|
| Secondary |
Pain level assessed by the VAS (visual analog scale) questionnaire |
Scale range 0-10, in which a higher score represents more pain. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD. |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
|
| Secondary |
Adverse Events according to CTCAE v5.0 |
Adverse events will be recorded using International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, the investigator will assess whether those events are drug related. Every OPD visit (every 3 months until PD) |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
|
| Secondary |
Circulating tumor DNA (ctDNA) levels |
ctDNA levels will be assessed to evaluate whether treatment response and disease progression can be predicted. Baseline, 3 months, 6 months, and at PD. |
through study completion, estimated after 3 years |
|
| Secondary |
mRNA expression levels of AR and AR splice variants |
mRNA expression of AR and AR splice variants on baseline and post-treatment tumor tissue samples to evaluate whether treatment response and disease progression can be predicted. Pre-treatment and post-treatment (i.e. PD) |
through study completion, estimated after 3 years |
|
| Secondary |
mRNA expression levels of SRD5A1/SRD5A2 |
mRNA expression of SRD5A1/SRD5A2 on baseline and post-treatment tumor tissue samples to evaluate whether treatment response and disease progression can be predicted. Pre-treatment and post-treatment (i.e. PD) |
through study completion, estimated after 3 years |
|
