prostate cancer
Conditions
Brief summary
The main study parameters are the fractions of patients that have disease progression (as a surrogate for progression free survival defined in paragraph 2: objectives) within 6-month follow up in the two arms, A second main study parameter is the time to disease progression and meeting EOT 1 criteria in both groups
Detailed description
Secondary endpoints will be the ADT free survival, PSA response, toxicity defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0), radiological state of the disease expressed in the difference in amount and size of suspicious nodes 18F-PSMA PET/(diagnostic) CT and (whole body) MRI between pre- and post-therapy and quality of life assessments, in both arms
Interventions
Sponsors
Stichting Radboud University Medical Center
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are the fractions of patients that have disease progression (as a surrogate for progression free survival defined in paragraph 2: objectives) within 6-month follow up in the two arms, A second main study parameter is the time to disease progression and meeting EOT 1 criteria in both groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be the ADT free survival, PSA response, toxicity defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0), radiological state of the disease expressed in the difference in amount and size of suspicious nodes 18F-PSMA PET/(diagnostic) CT and (whole body) MRI between pre- and post-therapy and quality of life assessments, in both arms | — |
Countries
Cyprus, Netherlands
Outcome results
None listed